Active Pharma Ingredients (API)

Custom Pharma Services (CPS)

Global Generics

Generic Biopharmaceuticals

New Chemical Entities & Differentiated Formulations

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Product Query

APIDr. Reddy's offers an unparalleled portfolio to our customers, who include innovators and generic formulators worldwide. With a strong product portfolio of more than 140 products, including niches like oncology and hormones, and our “first in, last out” approach, it is little wonder we are today the third ranked API player globally. Our goal is always to enable our customers to be the first to launch a generic product and to provide value added services to help them remain competitive and profitable for the entire life cycle of the product. We have built the capabilities to consistently deliver on this promise in scale and across the largest product range.

A highly skilled global team focuses on timely delivery of products, product development, technology leadership, cost competitiveness, the highest levels of customer service, and full compliance with regulatory and quality requirements.

Our expertise in organic synthesis and process development complemented by a controlled supply chain enables us to provide our customers with high quality Bulk Actives at competitive prices. We are aggressively building our product portfolio to cater to generic players in the emerging markets and generic and patent challenge formulators in regulated markets.

Our operations capabilities are among our core strengths, with six USFDA approved plants in India, one in Mexico and our latest addition, a USFDA inspected plant in Mirfield, UK, having a total capacity of 3300KL.

Our API business is supported by our technologically advanced Product Development infrastructure, which identifies new products and is engaged every step of the way, from the conceptual stage to delivery of drugs to the market place. The Product Delivery Teams, the Centres of Excellence and IP teams help create value through Intellectual Property and proactive patenting; early development work on certain promising molecules; breakthrough product delivery; and by delivering cost leadership in API.

All the above advantages make Dr. Reddy's API, an ideal partner in your product development effort

Regulatory:

Dr. Reddy's is committed to the manufacture of premium quality products in compliance with all regulatory requirements and customer expectations. We operate in accordance with cGMP requirements and the USFDA and ICH guidelines & regulations. All our manufacturing facilities are successfully inspected for several products by the USFDA and various other Agencies.

We are aided by a Best-in-Class Regulatory Affairs Team and we support our customers with DMFs for their dosage form approvals / ANDA filings. We have filed several DMFs in US, Canada (PMFs), Europe, Turkey, Korea, CIS and many more in other parts of the world. Some of our products have also recieved the Certificate of Suitability (COS) from European Pharmacopoeia

Our Customer support on Technical and Regulatory queries with constant focus on responsiveness, reliability, customization, and confidentiality set us apart from others. Continuous adaptation to the latest developments in global regulatory procedures and active partnership with Pharmacopoeial bodies give us cutting edge in this area.

Intellectual Property:

Competent and well equipped Intellectual Property Management Cell of Dr. Reddy’s facilitates the creation of intellectual wealth by navigating the Research and Development work and honoring others intellectual property. A team of well qualified IP experts comprising specialists from diverse fields of science are involved in evaluating techno-legal and techno-commercial aspects of the products, strategic product development, competitive IP generation and patenting, leveraging the intellectual property across the globe. This is a continuous process aimed at providing generic medicines at affordable prices to the mankind. IPM cell in Dr Reddy's also facilitates P-IV challenges leading to early generic launch of the products in the US market.

Dr. Reddy's bulk manufacturing operations are spread across six units in Andhra Pradesh, India, a state-of-the-art facility in Mexico and a manufacturing site based in Mirfield, UK. These facilities have been built and are operated in accordance with the latest regulatory guidelines on cGMP. Our facilities have been inspected by the USFDA and numerous other international regulatory agencies for all major products.

A brief overview of our API manufacturing facilities.

Unit 1

1. Set up in 1985

2. Located at Bollaram, Hyderabad

3. Has a Reaction Volume Capacity of 130 KL

4. Is USFDA Inspected and ISO-9001 certified

Unit 2

1. Set up in 1986

2. Located at Bollaram, Hyderabad

3. Has a Reaction Volume Capacity of 152 KL

4. Is USFDA Inspected and ISO-9001 certified

Unit 3

1. Set up in 1995

2. Located at Bollaram, Hyderabad

3. Has a Reaction Volume Capacity of 71 KL

4. Is USFDA Inspected and ISO-9001 certified

Unit 4

1. Set up in 1984

2. Located at Jeedimetla, Hyderabad

3. Has a Reaction Volume Capacity of 110 KL

4. Is USFDA Inspected and ISO-9001 certified

Unit 5

1. Set up in 1987

2. Located at Miriyalaguda, 150 kms from Hyderabad

3. Has a Reaction Volume Capacity of 700 KL

4. Is USFDA Inspected and ISO-9001 certified

5. Has achieved 'Zero Discharge'

Unit 6

1. Set up in 1990

2. Located at Pydibheemavaram, 800 kms from Hyderabad

3. Has a Reaction Volume Capacity of 570 KL

4. Is USFDA Inspected and ISO-9001 certified

Unit 7

1. Our API facility in Mexico gives us niche steroidal API capacities and has the world’s largest capacity for sodium naproxen

   Unit 8

1. The chiral and biocatalysis technology at the Cambridge facility and the scale up capability in Mirfield adds significant value to the CPS business offerings.

Custom Pharma Services  

Our Custom Pharmaceutical Services (CPS) business serves several ‘innovators’, both Big Pharma and emerging biotech, and a large number of emerging Pharma companies. Within a short span, we have become the largest CPS player from India and a partner-of-choice to innovators, offering top-end technical expertise, tailor-made pharma solutions and a track record of bringing innovations to the market quickly, efficiently and economically.

We offer both speed and flexibility. We have the capability to supply both small-scale clinical trial quantities and commercial-scale requirements. Our end-to-end services and competitive pricing makes a compelling value proposition to our global ‘innovator’ customers.

Niche technology-led acquisitions have made us a one-stop shop for many customers. Our acquisition of Roche's API manufacturing unit in Mexico added the capability to manufacture niche steroidal APIs. The acquisition of the Small Molecule business of Dow Pharma at its Mirfield and Cambridge sites in the UK has further strengthened our portfolio and service offerings for our customers. We now also offer a pool of chiral technologies, including biocatalysis.

We aim to be the preferred partner for innovator companies by providing a complete range of services that are necessary to take their innovations to the market with greater speed, efficiency and lower capital expenditures.

CPS Mirfield The chiral and biocatalysis technology at the Cambridge facility and the scale up capability in Mirfield adds significant value to the CPS business offerings.

Global Generics

Branded GenericsOur Branded Generics portfolio offers over 200 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology. Brands like Omez, Ciprolet, Nise, Enam, Ketorol, Exifine and Cetrine enjoy leadership positions in several key markets, including India, Romania, Venezuela, Russia & the CIS countries.

Our 2,000 plus representatives, armed with technology enabled devices and supported by a well integrated back-end service deliver value to our customers on every call. Deep customer relationships, quality medicines and consistently delivered promise make us a trusted brand across the world.

Unbranded GenericsIn the unbranded generics space, we have capitalized on every opportunity to bring our high-quality products to more people around the world. A synchronized supply chain that leverages our strong product development capabilities, state-of-the-art manufacturing and vertical integration with our own APIs has created a creditable track record of successful “Day 1” launches, with significant market shares in all our key markets. Our transparent and strong relationships with pharmacy chains, insurance funds and other distributor networks help us deliver upon our promise to customers and patients globally.

Our generics offerings deliver quality at cost-effective prices in the highly regulated markets of the United States, UK and Germany. In the US, we rank among the top 12 generic companies, with 34 product families being marketed and a large pipeline pending approval. In the UK, we have more than 30 products in the market. Our acquisition of betapharm, Germany's 5th largest generics company, further consolidated our presence in the European Union (EU), with 145 products in the market.

Dr. Reddy’s began as an API manufacturer in 1984, producing high-quality APIs to first the Indian, and later, the international markets. In 1987, we started our formulations operations and, after becoming a force to reckon with in the Indian formulations market, went international in 1991.

In India, we have a product portfolio of over 200 brands in major therapeutic areas, with an emphasis on gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, probiotic, pediatrics and dermatology.

Today, our value proposition to our customers derives from an optimal operating system in which operations, product development and marketing & sales are fully integrated. Operations and the supply chain are aligned to ensure high availability, pull based replenishment of products at the retail level and superior inventory turns to our customers. This advantage is combined with a highly effective prescription generation detailing effort.

A field force of over 1,400 motivated and knowledgeable representatives supported by an integrated network of back-end services and armed with handheld devices for quick information access add value to every customer call and interaction.

With a range of over 200 brands across 13 therapeutic areas, Dr. Reddy’s aims to further consolidate its position as an industry leader in the Indian pharma market.

Key therapeutical area

Therapy Name

Anti Diabetic

Anti-Infective

Blood Related

Cardiology

Dermatology

Gastrointestinal

Gynaecology

Neurology / CNS

Pain / Analgesics

Respiratory

Stomatologicals

Urology

Vitamins / Minerals / Nutrients

India Product List

BRAND MOLECULE THERAPHY

ACETEC  ACITRETIN Derma

ALADIN  ANTIOXIDANTS EXCL.EICOSA. Vitamins / Minerals / Nutrients

ALFOO  OTHER DRUGS FOR BPH Uro

ANAIDA  DICLOFENAC INJECTABLES Pain / Analgesics

ANTOXID  ANTIOXIDANTS EXCL.EICOSA. Vitamins / Minerals / Nutrients

ANTOXID-HC  ANTIOXIDANTS EXCL.EICOSA. Vitamins / Minerals / Nutrients

AQUADERM  EMOLLIENTS,PROTECTIVES Derma

ASTERIDE  OTH. CORTICO. ORAL SOLIDS Hormones

ATOCOR  ATORVASTATIN Cardiac

ATOCOR-E  ATORVA + EZETEMIBE Cardiac

ATOCOR-F  FENOFIBRATE+ATORVASTATIN Cardiac

ATOCOR-N  NICOTINIC ACID+ATORVASTAT Cardiac

ATOCOR-R  OTHER CHOLESTEROL COMB. Cardiac

AVERTZ  PREGABALIN Neuro / CNS

BECELAC  OTH.B-COMP.COMB. SOLIDS Vitamins / Minerals / Nutrients

BECELAC-PB  C.BUTYRICIUM Gastrointestinal

BECOZINC  VIT. B-COMP. WITH ZINC Vitamins / Minerals / Nutrients

BETAONE-AM  AMLODIPINE + OTHERS Cardiac

BETAONE-R  OTHER HYPOTENSIVE COMB. Cardiac

BETAONE-XL  METOPROLOL Cardiac

BIO-E  VITAMIN E Vitamins / Minerals / Nutrients

CAPIBINE  CAPECITABINE Others

CARDIOPRIL  RAMIPRIL Cardiac

CARDIOPRIL-H  RAMIPRIL+ HYDROCHLORTHIAZ Cardiac

CEFALONG  OTH. CEPHALO. COMB. SOLID Anti-Infective

CEFALONG  CEPHALEXIN ORAL SOLIDS Anti-Infective

CELADRIN  ANTI-ARTHRITIC PREP. SOL. Pain / Analgesics

CELADRIN  OTH. ANTIRHEU. NON-STR. Pain / Analgesics

CETRINE  CETIRIZINE ORAL LIQUIDS Respiratory

CETRINE  CETIRIZINE ORAL SOLIDS Respiratory

CHEERIO  STOMATOLOGICALS Stomatologicals

CIPROLET  CIPROFLOXACIN ORAL SOLIDS Anti-Infective

CIPROLET  CIPROFLOXACIN INJECTABLES Anti-Infective

CIPROLET  CIPROFLOXACIN Ophthal / Otologicals

CIPROLET-A  CIPRO.+ TINI. SOLIDS Gastrointestinal

CLAMP  AMOXY. & CLAV. SOLIDS Anti-Infective

CLAMP  AMOXY. & CLAV. LIQUIDS Anti-Infective

CLAMP  CLOXA.& AMPI.COMB.SOLID Anti-Infective

CLAMP  AMOXY. & CLAV. INJECT. Anti-Infective

CLAMP  CLOXA.& AMPI.COMB.INJECT Anti-Infective

CLEARZ  KOJIC ACID Derma

CLOHEX  STOMATOLOGICALS Stomatologicals

CLOHEX-PLUS  STOMATOLOGICALS Stomatologicals

COMBIHALE-FB  FORMOTERAL+BUDESONIDE Respiratory

COMBIHALE-FF  OTHER COMB.BRONCHO.INH Respiratory

CYTOGEM  GEMCITABINE Others

DACOTIN  OTH.CYTOSTATICS Others

DEVIPROST  OTH.OXYTOCICS INJECTABLES Gynaec.

DIALEX  COUGH PREP. ETHICALS Respiratory

DIAVISTA  PIOGLITAZONE Anti Diabetic

DICYNENE  ETHAMSYLATE Gynaec.

DOCETERE  OTH.CYTOSTATICS Others

DOLOGEL  STOMATOLOGICALS Stomatologicals

DOXOBID  OTHERS PLA.BRONCHO.SOL. Respiratory

DOXOBID  OTHER PLAIN BRONCHO.LIQ. Respiratory

DOXT  DOXYCYCLINE ORAL SOLIDS Anti-Infective

DUTALFA  OTHER DRUGS FOR BPH Uro

DUTAS  DUTASTERIDE Uro

DUTAS-T  OTHER DRUGS FOR BPH Uro

DYNAPRES  TAMSULOSIN Uro

EBERNET  OTHER TOPICAL ANTIFUGALS Derma

EBIZA-L  ANTIOXIDANTS EXCL.EICOSA. Vitamins / Minerals / Nutrients

ECONORM  S.BOULADRIL Gastrointestinal

ELINA  OTHER ANTI-HIST. PL.SOL. Respiratory

ENAM  ENALAPRIL Cardiac

ENAM-D  ENALAPRIL+ HYDROCHLORTHIA Cardiac

ETURA  OTH. PL. ANTIRHEU.SOLIDS Pain / Analgesics

FINAST  FINASTERIDE Uro

FINAST-T  OTHER DRUGS FOR BPH Uro

FINAX  FINASTERIDE Uro

FIONA  RALOXIFENE & COMB Gynaec.

FITTY DENT  STOMATOLOGICALS Stomatologicals

GAITY  GATIFLOXACIN Anti-Infective

GAITY  OTHER QUINO.INJECTABLES Anti-Infective

GEMONE  GEMIFLOXACIN Anti-Infective

GLA  PRIMROSE OIL/GLA & COMB. Vitamins / Minerals / Nutrients

GLA-M  MECOBALAMIN COMB. Vitamins / Minerals / Nutrients

GLIMY  GLIMEPRIDE Anti Diabetic

GLIMY-M  GLIMEPIRIDE+METFORM. Anti Diabetic

GLIMY-MP  PIOGLITAZ.+METFORM.+GLIM. Anti Diabetic

GLIMY-P  PIOGLITAZ.+ GLIMEPRIDE Anti Diabetic

GLIOZ  OTH.ANTILEUKAEMICS Others

GRAFEEL  ALL OTH.THERAPEUTIC PREP. Others

GRIS-OD  SYSTEMIC,GRISEOFULVIN Derma

HILIN  OTH. PL. ANTIRHEU.SOLIDS Pain / Analgesics

HYALOSYN  ANTI-ARTHRITIC PREP. INJ. Pain / Analgesics

IBUCLIN  IBUPRO.COMB.ORAL SOLIDS Pain / Analgesics

IMNIT  ISOSORBIDE-5-MONONITRATE Cardiac

INSTREL  TRAMADOL COMB. SOLIDS Pain / Analgesics

INSTREL  ANTIPRURITICS Derma

IRNOCAM  OTH.CYTOSTATICS Others

K CIT  URINARY ALKALISERS Uro

KETOROL  OTHER ORAL SOLIDS Pain / Analgesics

KETOROL  OTHER INJECTABLES Pain / Analgesics

LANZAP  LANSOPRAZOLE Gastrointestinal

LEON  LEVOFLOXACIN Anti-Infective

LEON  OTHER QUINO.INJECTABLES Anti-Infective

LOSTATIN  LOVASTATIN Cardiac

MEGA-3  ANTIOXIDANTS WITH EICOSA. Vitamins / Minerals / Nutrients

MENOSAFE  PHYTOESTROGENS Gynaec.

METORAL  METOLAZONE Cardiac

METROHEX  STOMATOLOGICALS Stomatologicals

MINTOP  MINOXIDIL Derma

MITOTAX  PACLITAXEL Others

MOREASE  MEBEVERINE Gastrointestinal

MOREASE-I  MEBEVERINE Gastrointestinal

MUCOLITE  COUGH PREP. ETHICALS Respiratory

NIALIP  NICOTINIC ACID Vitamins / Minerals / Nutrients

NIAP  NIME.COMB.ORAL SOLIDS Pain / Analgesics

NICETAMOL  PARACETAMOL ORAL LIQUIDS Pain / Analgesics

NICETAMOL  PARACETAMOL ORAL SOLIDS Pain / Analgesics

NILTAN  OTHER DEMELANIZING AGENTS Derma

NISE  NIMESULIDE ORAL SOLIDS Pain / Analgesics

NISE  NIMESULIDE ORAL LIQUIDS Pain / Analgesics

NISE  NSAIDS Pain / Analgesics

NISE  OTH. PL.ANTIRHEU. INJECT. Pain / Analgesics

NISE-MR  TIZANIDINE+NIMESULIDE COM Pain / Analgesics

NORILET  NORFLOXACIN ORAL SOLIDS Anti-Infective

NORILET  NORFLOXACIN Ophthal / Otologicals

NORILET-A  NORFLOX.+ TINI. SOLIDS Gastrointestinal

OMEZ  OMEPRAZOLE ORAL SOLIDS Gastrointestinal

OMEZ  OMEPRAZOLE.INJ Gastrointestinal

OMEZ FF  OMEPRAZOLE ORAL SOLIDS Gastrointestinal

OMEZ-D  OMEPRAZ.+ DOMPERID. Gastrointestinal

OPTISULIN  PLAIN ORAL SOLIDS Vitamins / Minerals / Nutrients

ORDENT  OFLOXACIN+ORNIDAZOL.SOL Gastrointestinal

ORETA  LETROZOLE Others

OSETRON  ONDANSETRON INJ. Gastrointestinal

OSETRON  ONDANSETRON ORAL SOL. Gastrointestinal

OVISTA  ANTIOXIDANTS EXCL.EICOSA. Vitamins / Minerals / Nutrients

PALZEN  OTHER INJECTABLES Gastrointestinal

PECEF  CEFPODOXIME LIQUIDS Anti-Infective

PECEF  CEFPODOXIME SOLIDS Anti-Infective

PEDICLORYL  PSYCHOSTIM.,NEUROTONICS Neuro / CNS

PLAGRIL  CLOPIDOGREL Cardiac

PLAGRIL-A  ASPIRIN + CLOPIDOGREL Cardiac

PLERMIN  DRESSINGS Derma

PROSENIOR  OTHERS Gastrointestinal

PUNOX  OTHER QUINO.ORAL SOLIDS Anti-Infective

RAZO  RABEPRAZOLE Gastrointestinal

RAZO  RABEPRAZOLE INJ. Gastrointestinal

RAZO-D  RABEPRA.+ DOMPERID. Gastrointestinal

REBALANZ  ORAL ELECTROLYTES Gastrointestinal

RECLIDE  GLICLAZIDE Anti Diabetic

RECLIMET  GLICLAZIDE + METFORMIN Anti Diabetic

REDEFINE  CONV.IRON SOLIDS Gynaec.

REDITUX  OTH.ANTILEUKAEMICS Others

REDOTIL  RACECADOTRIL Gastrointestinal

RELENT  CETIRIZINE COMB. SOLIDS Respiratory

RELENT  CETIRIZINE COMB. LIQUIDS Respiratory

RELENT-L  LEVOCETIRIZINE COMB. SOLI Respiratory

RETOZ  ETORECOXIB ORAL SOLIDS Pain / Analgesics

REZUM  DRUGS FOR ED Uro

RIFLUX  ANTACID+ANTIFLATU.SOLIDS Gastrointestinal

RIFLUX  ANTACID+ANTIFLATU.LIQ Gastrointestinal

RIFLUX  PLAIN ANTACIDS Gastrointestinal

ROZAT  ROSUVASTATIN Cardiac

RUPANEX  OTHER ANTI-HIST. PL.SOL. Respiratory

SAL MUCOLITE  SALBUTAMOL COMB. Respiratory

SALICYLIX  SALICYLATE COMB EXCL CORT Derma

SEMI RECLIMET  GLICLAZIDE + METFORMIN Anti Diabetic

SENQUEL  STOMATOLOGICALS Stomatologicals

SENQUEL-AD  STOMATOLOGICALS Stomatologicals

SENQUEL-F  STOMATOLOGICALS Stomatologicals

SENQUEL-F-LAMI  STOMATOLOGICALS Stomatologicals

S-FLO  STOMATOLOGICALS Stomatologicals

SPARACID  SUCRALFATE. Gastrointestinal

SPARFLO  SPARFLOXACIN ORAL SOLIDS Anti-Infective

STAMACE  AMLODIPINE + RAMIPRIL Cardiac

STAMCOR  ATORVASTATIN+AMLODIPINE Cardiac

STAMLO  AMLODIPINE Cardiac

STAMLO BETA  ATENOLOL+AMLODIPINE Cardiac

STAMLO D  OTHER ANTIHYPERT+DIURETIC Cardiac

STOLIN  STOMATOLOGICALS Stomatologicals

STOLIN-R  STOMATOLOGICALS Stomatologicals

STYPTOCHROME  VITAMIN K AND OTHERS Blood Related

STYPTOVIT  VITAMIN K AND OTHERS Blood Related

STYPTOVIT-K  VITAMIN K AND OTHERS Blood Related

SUEZ  CONV.IRON INJ. Gynaec.

SUPANAC  DICLOFENAC ORAL SOLIDS Pain / Analgesics

TABI  OTH. GONADOTROPHINS Gynaec.

TAZZLE  DRUGS FOR ED Uro

TELSARTAN  TELMISARTAN Cardiac

TELSARTAN-AM  AMLODIPINE + OTHERS Cardiac

TELSARTAN-H  TELMISARTAN + HCT Cardiac

TELSARTAN-R  TELMISARTAN+RAMIPRIL Cardiac

THAANGIO  IMMUNO MODULETORS Others

TINIMOX  OTHER COMB.SOLID Gastrointestinal

TORQ  TOLTERODINE Uro

TROSPA  DROTAVARINE Gastrointestinal

ULTRAVEX  OTHER CORTICOSTEROIDS Derma

VANTEJ  STOMATOLOGICALS Stomatologicals

VELOCIT  OTHER DIAGNOSTIC AGENTS Gynaec.

VENUSIA  EMOLLIENTS,PROTECTIVES Derma

VIBOLIV  OTH.HEPATIC PROT.LIPO SOL Hepatoprotectives

VIBOLIV  OTH.HEPATIC PROT.LIPO INJ Hepatoprotectives

VOZUCA  VOGLIBOSE Anti Diabetic

Z & D  OTHER MINERAL SUPPLEMENT Vitamins / Minerals / Nutrients

ZORAN  RANITIDINE ORAL SOLIDS Gastrointestinal

ZORAN  RANITIDINE INJECTABLES Gastrointestinal

Generic Biopharmaceuticals

Biologics, or biopharmaceuticals, are protein therapeutics drugs that are produced using recombinant DNA technology. Over the past two decades, Biologics have revolutionized the treatment landscape in several therapeutic areas, especially in Oncology & Autoimmune disorders. The biggest advantage of Biologics over conventional medicines is that they are targeted and highly specific. However, Biologics are more complex and difficult to develop and are therefore relatively expensive. As a consequence, in developing countries they are unaffordable for most people.

We view generic biopharmaceuticals as an integral part of our mid to long term growth strategy and believe that building depth in development and manufacturing capabilities will be critical in accessing this opportunity. We have made significant efforts in this direction and have over the years succeeded in creating world class infrastructure and a highly capable team.

Strengths

Proven generic biopharmaceutical development capabilities with two marketed products - GrafeelTM (filgrastim) and RedituxTM

(rituximab), in emerging markets

Developed and launched Reditux (rituximab) - the world's first generic monoclonal antibody

The product portfolio spans multiple therapeutic areas - oncology, auto-immune diseases and CNS

cGMP facilities to manufacture Biologics, in adherence with global regulatory requirements at a significant cost advantage

Pipeline

We have a pipeline of 8 generic biopharmaceuticals in various stages of development with two in clinical development stage

REDITUX

Reditux™ is the Dr. Reddy’s brand of rituximab, a chimeric murine/human anti-CD20 monoclonal antibody (MAb), and is the world's first

biosimilar monoclonal antibody. Reditux™ is used in the treatment of Non-Hodgkin’s Lymphoma, which is a group of cancers arising

from lymphocytes, a type of white blood cell

GRAFEEL

GRAFEEL is one of the hemopoietic growth factors that stimulate the proliferation of neutrophils. Grafeel is produced by a strain of

Escherichia coli bearing a genetically engineered plasmid that contains a human G-CSF gene. GRAFEEL regulates the production,

maturation, and function of cells of the neutrophil lineage. GRAFEEL is used to treat cancer patients suf

Capabilities

Infrastructure:

cGMP E.Coli manufacturing

cGMP mammalian cell-culture manufacturing

Facilityo In accordance with cGMP guidelines; approved by regulatory agencies

o Has the ability to handle most mammalian expression platforms; currently dealing only with products based on CHO cell expression

Overall capacityo 800L: 4 X 200L bioreactor

o One downstream processing train

Fill-finish with lyophilizer: Equipped to handle vials (liquid and lyophilized) and pre-filled syringes.

o Vials: 4 million annually (Expandable to 7 million); Volumes: 1 to 50 ml

o Pre-filled syringes: 3 million annually (Expandable to 6 million)

o Lyophilizer: 7 sq. meters

o R&D Center

o Animal facility

System and expertise in developing biological products of varied complexity

Proven skills in technology transfer, analytical development and scale-up

Expertise in regulatory support and filing across key geographies

New Chemical Entities & Differentiated Formulations

We are engaged in the discovery, development, and commercialization of novel small molecule agents to address significant clinical unmet needs. We are also developing novel formulations of approved products whose safety and efficacy profiles are well characterized. Although distinct, both efforts seek to improve the care of patients suffering from serious diseases and impaired quality of life. Our therapeutic areas of focus are bacterial infections, metabolic disorders, and pain/inflammation. 

Focus Therapeutic Areas

Bacterial infections: The incidence of hospital acquired infections is growing as drug-resistant bacteria are becoming more difficult to treat. There are significant challenges in adequately treating infections caused by multi-drug resistant pathogens such as staphylococcus aureas, pseudomonas aeruginosa, and acinetobacter baumannii. The resultant infections are often serious and life-threatening. We are working to identify new approaches to treating these infections with products that have improved efficacy and tolerability profiles.

Metabolic Disorders: Cardiovascular Disease is one of the leading causes of death globally. Many patients suffering from CVD are also afflicted with insulin resistance, type 2 diabetes, dyslipidemia, and obesity. While there are several treatment options for a few of these conditions, a need persists for effective and safe therapies that address insulin resistance, obesity, low HDL cholesterol and atherosclerosis. We have several programs targeting one or more of these disease conditions.

Pain/Inflammation: The prevalence of chronic and acute pain is growing steadily as our population ages and diagnosis rates improve. Although

there are a number of medications to treat chronic and acute pain, new treatments that are both safe and tolerable remain essential. We are developing products with improved efficacy and side effect profiles in several areas of acute and chronic pain.

Our most advanced Differentiated Formulations efforts are in dermatology, where we have launched several effective and innovative products through our wholly owned subsidiary Promius Pharma. Headquartered in Bridgewater, New Jersey (USA), Promius Pharma is a branded specialty company with a portfolio of in licensed dermatological products and an internal pipeline of topical products in different stages of development. Promius Pharma’s current portfolio contains innovative topical products for the treatment of psoriasis, atopic dermatitis and seborrheic dermatitis. 

For more information about Promius Pharma, please visit www.promiuspharma.com 

Promiseb™ Topical Cream

Promiseb™ is contraindicated in persons with a known hypersensitivity to any component of the formulation. Please see accompanying important safety information and full prescribing info. For more info, visit www.Promiseb.com. Promiseb™ does not contain milk, wheat, peanut or animal derivatives. This Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with a known allergy to nuts or nut oils should consult their physician before using this topical preparation.

Scytera Foam

Scytera Foam is a novel coal tar foam for the treatment of psoriasis, a skin disease that affects approximately 7.5 million Americans according to the National Psoriasis Foundation. Scytera Foam delivers a time tested active ingredient, coal tar, in a cosmetically elegant foam formulation. Please visitwww.scytera.com for more information about Scytera Foam, including usage instructions. 

EpiCeram® Skin Barrier Emulsion

EpiCeram® Skin Barrier Emulsion is a novel prescription therapy for the treatment of atopic dermatitis, a skin disease that affects more than 15 million patients in the United States. EpiCeram was developed to specifically address the defective skin barrier of atopic patients to safely and effectively control the signs and symptoms of atopic dermatitis. Please visitwww.EpiCeram.com for more information about EpiCeram Emulsion, including prescribing information.

Dr. Reddy's LaboratoriesFrom Wikipedia, the free encyclopedia

Dr Reddy's Laboratories Ltd.

Type Public

Industry Pharmaceuticals

Founded 1984

Headquarters Hyderabad, Andhra Pradesh,India

Key people Anji Reddy, Chairman

GV Prasad, CEO

Revenue $1.5 billion (May 2007)

Net income $216 million (May 2007)

Employees 8,225

Website www.drreddys.com

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Dr. Reddy's Laboratories Ltd., trading as Dr. Reddy's, founded in 1984 by Dr. K. Anji Reddy , has

become India's second biggestpharmaceutical company. Dr. Anji Reddy had worked in the publicly-owned Indian

Drugs and Pharmaceuticals Ltd. Reddy's manufactures and markets a wide range of pharmaceuticals in India

and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients for drug

manufacture, diagnostic kits, critical care, and biotechnology products.

Dr. Reddy's began as a supplier to Indian drug manufacturers, but it soon started exporting to other less-

regulated markets that had the advantage of not having to spend time and money on a manufacturing plant that

that would gain approval from a drug licensing body such as the U.S. Food and Drug Administration (FDA). By

the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to

begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants

in more-developed economies. This allowed their movement into regulated markets such as the US and Europe.

By 2007, Dr. Reddy's had six FDA-plants producing active pharmaceutical ingredients in India and seven FDA-

inspected and ISO 9001(quality) and ISO 14001 (environmental management) certified plants making patient-

ready medications – five of them in India and two in the UK.[1]

In 2010, the family-controlled Dr Reddys denied[2] that it was in talks to sell its generics business in India to US

phamarceutical giant Pfizer,[3] which had been suing the company for alleged patent infringement after Dr Reddys

announced that it intended to produce a generic version of Atorvastatin, marketed by Pfizer as Lipitor, an anti-

cholesterol medication.[4][5]Reddys was already linked to UK pharmaceuticals multinational Glaxo Smithkline .[6]

Contents

 [hide]

1 Dr Reddy's and regulations

o 1.1 Generics goldmine

o 1.2 India: patents and profits

o 1.3 The passage from India

o 1.4 Drug discovery troubles

o 1.5 Diabetes drug in Phase III trial

2 Key people

3 Key products

o 3.1 Top active pharmaceutical ingredients

o 3.2 Top-10 brands in India

o 3.3 Top brand in Middle East

4 References

5 External links

[edit]Dr Reddy's and regulations

This article or section needs copy editing resulting in readable prose, proper spacing, and/or standard section length.You can assist by editing it now. A how-to guide is available.(May 2010)

[edit]Generics goldmine

With drug prices high in most OECD member states, health services came to rely on generic versions of drugs

rather than the branded 'originals' – in the UK this was made the result of advice to National Health

Service doctors from the country's health department and in the US by the 1984 Hatch-Waxman Act or Drug

Price Competition and Patent Term Restoration Act [7]  and the financial liberalization of the mid 1990s[8] gave what

had been 'third world' pharmaceuticals firms a chance of getting into more lucrative markets, using their ability to

reverse-engineer. In 1997, the U.S. FDA created an incentive for generics companies to engage branded drug

makers in court, with the introduction of the Para 4 filing law, in a bid to generate competition. The law rewarded

generic manufacturers for challenging existing patents instead of waiting for them to expire.

[edit]India: patents and profits

In the 60 years since India's independence, the domestic pharmaceutical industry has been shaped primarily by

regulation. Initially, multinationals had a near monopoly on pharmaceuticals. They imported and marketed

complete formulations in India, mainly low-cost generics along with a few highly priced specialty drugs. When the

government increased pressure to deter the import of finished products, multinationals set up formulating units

and continued importing bulk drugs.

In the 1960s, the Indian government laid the foundation for a domestic pharmaceuticals industry by promoting

the state-owned Hindustan Antibiotics Ltd. and Indian Drugs and Pharmaceuticals Ltd. for the manufacture of

bulk drugs. However, the multinationals maintained their lead because of their technical expertise, financial

muscle, and ability to move innovations from one market to another. The high cost of original research, the

sophisticated scientific knowledge needed and a lack of financing options worked against the private-sectorIndian

companies.

This state of affairs changed with the 1970 Indian Patent Act, whereby substances used in foods and

pharmaceuticals were not granted product patents. Process patents were granted for a period of five years from

the date of grant or seven years from the date of filing, whichever was earlier. Process modifications were easier

to accomplish, and there was a rapid influx of domestic manufacturers. These companies generally started with

bulk drugs and gradually progressed into complete medications. The multinationals were constrained by their

parent companies' product ranges but the Indian producers could make almost anything. Not paying product

patent royalties cut the cost of local manufacture and helped Indian producers thrive.

Shortly thereafter, the Drugs Price Control Order put a ceiling on prices of certain mass-usage formulations.

Since selling at such low prices could cause discontent in their home markets, multinationals dramatically

curtailed new product launches, further boosting India's domestic players.

Under the Foreign Exchange Regulations Act in the late 1970s, the multinationals had to reduce their stakes in

Indian ventures to 40%, or comply with certain export obligations and keep their equity stake at 51%. Many

multinationals preferred not to do business in that climate – another shot in the arm for India's pharmaceutical

industry.

In 1986, Reddy's started operations on branded formulations. Within a year Reddy's had launched Norilet,

Reddy's first recognized brand in India. But, thanks to its superior process technology, Reddy's scored a big

success with Omez, its branded omezaprole – ulcer and reflux oesophagitis medication – launched at half the

price of other brands on the Indian market at that time.

Within a year, Reddy's became the first Indian company to export the active ingredients for pharmaceuticals to

Europe. In 1987, Reddy's started to transform itself from a supplier of pharmaceutical ingredients to other

manufacturers into a manufacturer of pharmaceutical products.

[edit]The passage from India

First it moved into Russia, forming a joint venture with the country's biggest pharmaceuticals producer Biomed in

1992, pulling out in 1995 amid accusations of scandal, involving 'a significant material loss due to the activities of

Moscow's branch of Reddy's Labs with the help of Biomed's chief executive[9] selling the joint venture to the

Kremlin-friendly Sistema group and buying the whole company in 2002.

In 1993, Reddy's entered into a joint venture in the Middle East and created two formulation units there and in

Russia. Reddy's exported bulk drugs to these formulation units, which then converted them into finished

products. In 1994, Reddy's started targeting the US generic market by building state of art manufacturing facility.

Reddy's path into new drug discovery involved targeting speciality generics products in western markets to gain

drug discovery abilities. The reason why development of speciality drugs was an important link to the

development of new chemical entities is that all the elements that are involved in an NCE effort, such as

innovation in the laboratory, developing the compound, sending the sales team to the market etc. are also stages

in the development of a specialty drug. Reddy's also invested heavily in building R&D labs and is the only Indian

company to have significant R&D being undertaken overseas. Dr. Reddy's Research Foundation was established

in 1992 and dedicated to research in area of new drug discovery. At first, the foundation's drug research strategy

revolved around searching for analogues but its changed focus to innovative R&D, hiring new scientists –

especially Indian students studying abroad on doctoral and post-doctoral courses. In 2000, foundation set up

a US lab in Atlanta, dedicated to discovery and design of novel therapeutics. The lab is called Reddy US

Therapeutics Inc (RUSTI) and its main aim is the discovery of next-generation drugs

using genomics and proteomics. Reddy's research thrust focused on large niche areas in western markets – anti-

cancer, anti-diabetes, cardiovascular and anti-infection drugs.

Reddy's international marketing successes were built on a strong manufacturing base which itself was a result

of inorganic growth through acquisition of international and national facilities. Reddy's merged Cheminor Drug

Limited (CDL) with primary aim of supplying APIs to the technically demanding markets of North

America and Europe. This merger also gave Reddy's entry into value added generics business in the regulated

markets of APIs.

By 1997, Reddy's was ready for the next major step. From being an API and bulk drug supplier to regulated

markets like the USA and the UK, and a branded formulations supplier in unregulated markets like India and

Russia, Reddy's made the transition into generics by filing an Abbreviated New Drug Application (ANDA) in the

USA. The same year, Reddy's out-licensed a molecule for clinical trials to Novo Nordisk,

a Danish pharmaceutical company.

It strengthened its Indian manufacturing operations by acquiring American Remedies Ltd. in 1999. This

acquisition made Reddy’s the third largest pharmaceutical company in India, afterRanbaxy and Glaxo (I) Ltd.,

with a full spectrum of pharmaceutical products, which included bulk drugs, intermediates, finished dosages,

chemical synthesis, diagnostics and biotechnology.

Reddy’s started exploiting Para 4 filing as a strategy in bringing new drugs to the market at a faster pace. In 1999

it submitted a Para 4 application for Omeprazole- the drug it had so successfully marketed in India. In December

2000, Reddy’s had undertaken its first commercial launch of a generic product in the USA., and its first product

with market exclusivity was launched there in August 2001. The same year, it also became the first non-

Japanese pharmaceutical company from the Asia-Pacific region to obtain a New York Stock Exchangelisting.

Each of these achievements was path breaking for the Indian pharmaceutical industry.

In 2001 when Reddy’s became the first Indian company to launch the generic drug, fluoxetine (a generic version

of Eli Lilly and Company’s Prozac) with 180 day market exclusivity in the USA. Eli Lilly's antidepressant drug

Prozac had sales in excess of $1 billion per year in the late nineties. Barr Laboratories of the U.S. obtained

exclusivity for all of the approved dosage forms (10 mg, 20 mg) except one (40 mg), which was obtained by

Reddy’s. Lilly had numerous other patents surrounding the drug compound and had already enjoyed a long

period of patent protection. The case was heard twice by the Federal Circuit court, and Reddy’s won both

hearings. The importance of market exclusivity is illustrated by the fact that. Reddy’s generated nearly $70 million

in revenue during the six-month period. With such phenomenal returns at stake, Reddy’s was beginning to

gamble on litigation that could cost millions of dollars, depending on the length of the trial.

The fluoxetine marketing success was followed by the launch of ibuprofen tablets 400, 600 and 800 mg in the US

under its own brand name, in January 2003. Direct marketing under the Reddy’s brand name represented a

significant step in the company’s efforts to build a strong and sustainable US generic business. It was the first

step in building Reddy’s fully fledged distribution network in the US market. This was much on the lines of the

Indian software majors who have marketing professionals in the US.

In 2001 Reddy’s completed its US initial public offering of $132.8 million American Depositary Receipts issue and

also listed on the New York Stock exchange. Funds raised from the USinitial public offering helped Reddy’s

move into international production – and take over technology-based companies.

In 2002, Reddy’s started its European operations by acquiring two pharmaceutical firms in the UK. The

acquisition of BMS Laboratories and its wholly owned subsidiary, Meridian UK allowed Reddy’s to expand

geographically and gave company an opportunity to enter the European market. In 2003 Reddy’s also invested

US$. 5.25 million in equity capital of Bio Sciences ltd.

Auriegene Discovery Technologies, a contract research company was established as a fully owned subsidiary of

Reddy’s in 2002, to gain experience of drug discovery through contract research for other Pharma companies.

Reddy’s entered into a venture investment type of agreement with the Indian bank, ICICI. Under the terms of the

agreement, ICICI Venture funds the development, registration and legal costs related to the commercialization of

ANDAs on a pre-determined basis. On commercialization of these products, Dr. Reddy's pays ICICI Venture

royalty on net sales for a period of 5 years. Reddy’s successful growth into a fully integrated pharmaceutical

company in less than a decade was founded on a successful and targeted program of inorganic growth and

investments in process R&D. It had chosen a high risk-high gain strategy to growth by going into direct

competition with existing patent holders. A major challenge for Reddy’s is to find ways to de-risk its overall

strategy. One way may lie in managing the cash flows from the ‘safer’ API and formulations businesses. Another

way may be to seek out more experienced partners for the R&D business or use acquisitions to boost R&D

resources and revenues. It has chosen the global route and went on an acquiring spree.

In March 2002, Dr. Reddy’s acquired BMS Laboratories, Beverley, and it is wholly owned subsidiary Meridian

Healthcare, for EUR 14.81 million. These companies deal in oral solids, liquids and packaging, with

manufacturing facilities in London and Beverley in the UK. Recently, Dr. Reddy’s entered into an R&D and

commercialization agreement with Argenta Discovery Ltd., a private drug development company based in the

UK, for the treatment of COPD.

With growing success in the generics market, Reddy’s also came to realize the need for developing marketing

and distribution capabilities in the USA Reddy’s was considering several options for marketing

the hypertension product in 2003. The company already had one tie-up with Pharmaceutical Resources, Inc. to

market Fluoxentine 40 mg tablets. It also had a tie-up with Par Pharmaceuticals Inc., to produce and

market over-the-counter drugs in the U.S. In addition to the United States, Reddy’s generics business had

established a presence in the UK, is a platform for expansion into other countries in Europe. Reddy’s also plans

to expand its presence in Canada and South Africa. Its API business had sales in over 60 countries, with the US

and India being the most significant revenue contributors. The branded formulations business was active in over

30 countries and Reddy’s was a significant player in the Indian and Russian markets. The business planned to

significantly increase its presence in China, Brazil and Mexico in the near future.

Dr. Reddy’s entered into a 10-year agreement with Rheoscience A/S of Denmark for the joint development and

commercialization of Balaglitazone (DRF-2593), a molecule for the treatment of type-2 diabetes. Rheoscience

holds this product’s marketing rights for the European Union and China, while the rights for the US and the rest of

the world will be held by Dr. Reddy’s. Dr. Reddy’s conducted clinical trials of its cardiovascular drug RUS 3108

in Belfast, Northern Ireland, in 2005.The trials were conducted to study the safety and the pharmacokinetic

profiles of the drug, which is intended for the treatment of atherosclerosis, a major cause of cardiovascular

disorders.

Dr. Reddy’s entered into a marketing agreement with Eurodrug Laboratories, a pharmaceutical company based

in Netherlands, for improving its product portfolio for respiratory diseases. It introduced a second-generation

xanthine bronchodilator, Doxofylline, which is used for the treatment of asthma and chronic obstructive

pulmonary disease (COPD) patients.

In 2004, Reddy’s acquired Trigenesis Therapeutics Inc; the US based private dermatology company. This

acquisition gave Reddy’s access to certain products and proprietary technologies in dermatology segment. Dr.

Reddy’s Para 4 application strategy for generic business received a severe set back when Reddy’s lost the

patent challenge in case of Pfizer’s drug Norvasc (amlodipine maleate). Amlodipine maleate , the generic version

of Pfizer's Norvasc, is indicated for the treatment of hypertension and angina. The cost involved in patent

litigation as well as the strategic reversal affected Reddy’s plans to start speciality business in the US generic

markets.

In March 2006, Dr. Reddy’s acquired Betapharm Arzneimittel GmbH from 3i for EUR 480 million. This is one of

the largest-ever foreign acquisitions by an Indian pharmaceutical company. Betapharm is Germany’s fourth-

largest generics pharmaceuticals covering 3.5% market share including 150 active pharmaceutical ingredients.

Reddy’s has promoted India’s first integrated drug development company Perlecan Pharma Pvt Ltd together with

ICICI ventures capital fund management company Ltd and Citigroup Venture Capital  International growth

partnership Mauritius Ltd. The combined entity will undertake clinical development and out-licensing of New

Chemical Entity Assets.

Dr. Reddy's is presently licensed by Merck & Co. to sell an authorized generic version of the popular

drug simvastatin (Zocor) in the USA. Since Dr. Reddy's has a license from Merck, it is not subject to the

exclusivity period on generic simvastatin of 180 days from June 23, 2006, which is split between Ranbaxy

Laboratories (also from India) and Teva Pharmaceutical Industries .[10]

As on 2006, Dr. Reddy’s Labs crossed US $500 M in revenues flowing from segments such as APIs, Branded

Formulations and Generics with the former two segments accounting for almost 75% of revenues. On an overall

note, Dr. Reddy’s controls the entire supply chain and offers high-quality products at competitive prices at the

opportune time. It deals in and manages all the processes, from the development of the API to the submission of

finished dosage dossiers to the regulatory agencies. It has moved from strength to strength and has built a

variety of partnerships as well as acquisitions across its key overseas markets, US and Europe and had laid a

strong foundation and is well poised to take advantage of opportunities in international markets.

[edit]Drug discovery troubles

Dr. Reddy's spun off its drug discovery and research wing into a separate company called Perlecan Pharma

Private Limited in September 2005 which was hailed as an innovative move at that time but it had to be wound

down in 2008 due to funding constraints.[11] Dr. Reddy's was the first Indian pharma company to attempt such an

effort to de-couple risk of drug discovery from the parent company by creating a separate company with external

source of funding. Perlecan Pharma was part funded by ICICI Venture Capital and Citigroup Venture

International, both of which held a 43% stake in Perlecan for an estimated $22.5 million. However, the company

had to buy back the Perlecan shares from ICICI and Citigroup as the venture capitalists wanted out because of

their doubts in the commercial viability of the drugs candidates that were in Perlecan's pipeline. Dr. Reddy's

bought back the shares in July and Perlecan became a wholly owned subsidiary, however in the board meeting

set for 23 October, the company is set to amalgamate/absorb Perlecan, thereby making it an inhouse research

facility, like before 2005.[11]

In 2009, the company did a U-turn and has handed over discovery research and related Intellectual property to

its Bangalore based subsidiary, with the possibility of spinning it off as a different entity altogether. "The company

may be hoping to find a strategic partner in the future to share the risks and research funding." [12]

[edit]Diabetes drug in Phase III trial

The Phase III testing of the company's diabetes drug candidate, Balaglitazone, was delayed reportedly due to the

Danish research partner conducting the clinical trials facing financial problems[13] Rheoscience's parent company

Nordic Bioscience is believed to have undertaken to provide funds to Rheoscience to continue the trials and thus

live up to the contractual obligations to Dr. Reddy's.

In January 2010, Dr. Reddy's Laboratories announced that its first late-stage trial of the experimental diabetes

drug Balaglitazone hit its primary endpoint for the reduction of blood glucose levels. Dr Reddy's claims the data

"leaves the program on track to an eventual regulatory approval".[14]

[edit]Key people

On March 31, 2006 board members and senior executives included.

Mr. Amit Patel - Vice President, Corporate Development & Strategic Planning

Dr. K Anji Reddy, chairman

Mr. GV Prasad - vice chairman & chief executive

Mr. Satish Reddy - managing director & COO

Mr. B.Koteswar rao - independent director

Mr. Anupam Puri - independent director

Dr. Krishna G Palepu - independent director (Following the Satyam accounting scandal, media has reported

that Prof Palepu has been informally asked to quit the Dr. Reddy's Laboratories Board.[15])

Dr. Omkar Goswami - independent director

Mr. P N Devarajan - independent director

Mr. Ravi Bhoothalingam - independent director

Dr. V. Mohan - independent director

Dr. Rajinder Kumar - president, Research, Development and Commercialization (joined on April 30, 2007 left

the company in 2009-10 so no more associated with Dr. Reddy's)[16]

[edit]Key products

[edit]Top active pharmaceutical ingredients

Ciprofloxacin Hydrochloride

Ramipril

Terbinafine HCI

Ibuprofen

Sertaline Hydrochloride

Ranitidine HCI Form 2

Naproxen Sodium

Naproxen

Atorvastatin

Montelukast

Losartan Potassium

Sparfloxacin

Nizatidine

Fexofenadine

Ranitidine Hydrochloride Form 1

Clopidogrel  (Not in US due to 2007 patent case)

Omeprazole

Finasteride

Sumatriptan

[edit]Top-10 brands in India

Omez

Nise

Stamlo

Stamlo Beta

Enam

Atocor

Razo

Reclimet

Clamp

Mintop

[edit]Top brand in Middle East

Temad Co., Active Pharmaceutical Ingredients