www.arkgenpharma.cominfo@arkgenpharma.comsamrat@arkgenpharma.com

+91 80 4150 0424+91 99674 55776

Corporate Office Address:ArkGen Pharma Private Limited‘PSP SQUARE’, Site No: 201, 3rd Floor, Green Glen Layout, Bellandur Outer Ring Road, Bangalore - 560 103, Karnataka, India.

Manufacturing Site Address:Sonia OrganicsPlot No. 11/2, A�bele Industrial Area,Balagaranahalli, Anekal Taluk, Bangalore - 562 107.Karnataka, India.

Srini Pharmaceu�cals Pvt. Ltd.Plot No.10, Type C, Road No.8, Film Nagar, Hyderabad, India - 500096.

Syntho Chirals Pvt. Ltd. Plot No. 53B & 54P, Kolhar KIADB Industrial Area,Bidar-585 401, Karnataka, INDIA.

Mumbai Branch Office Address:ArkGen Pharma Private Limited 701, Trishul Terraces Annexe, Plot 32, Sector 20, Koparkhairane, Navi Mumbai – 400 709, India.

R&D Lab Address:ArkGen Pharma Private LimitedPlot No. 488B, 303 - 304, VITC Model Export Bhavan, Peenya Industrial Area, Bangalore - 560 058 Karnataka, India.

We believe in Leadership, Science, Innova�on & Care!

ArkGen Pharma Private Limited is a pharmaceu�cal company based at Bengaluru, India. We started our journey in 2014, offering technical exper�se with regulatory insight to our Partners and Associates in the Pharmaceu�cal arena.

We currently offer the following productsŸ Ac�ve Pharma Ingredients (API)Ÿ Key Star�ng Materials (KSM) for Ac�ve Pharma Ingredients (API)Ÿ Related Substances (Reference Standards, Impuri�es, metabolites and Deuterated compounds)

Ÿ Regulatory and Dossier Management- Compila�on of the dossier and filing to respec�ve regulatory authorit- Life-cycle management of dossier along with necessary gap analysis- Responding to queries from various regulatory agencies

ŸŸ Technology Transfer- Preparing gap analysis on client's documents with receiver sites- Op�mizing manufacturing process prior to transfer - Preparing risk evalua�on and mi�ga�on documents- Prepara�on of transfer/ valida�on protocols and Tech Transfer summary- Monitoring technology transfer opera�on during commercial produc�on- Periodic integrity and quality audits- Trouble shoo�ng and failure inves�ga�on- Reformula�on support if necessary in a mutually agreed development facility

Ÿ Facilita�on of CRO and CMO Services (at USFDA,EU,KFDA,TGA,COFEPRIS,DIGEMID,PICs,WHO-GMP approved facili�es)

Ÿ Procurement Services (procure RLDs in large volumes of a single batch or

mul�ple batches)

Ÿ Pharmaceu�cal manufacturing Facility Set-up and Turnkey Projects (in

compliance to target market regulatory guidelines)

Ÿ Clinical Trial Supplies (for clinical studies in India or other countries)

Ÿ Licensing (We are ac�vely seeking in-licensing and out-licensing arrangements and

strategic partnerships with various interna�onal pharma companies focused on marke�ng of generics to enter new segments and grow in these markets)

Ÿ Project Management (We can take up stand-alone project Management ac�vity

to monitor all types of projects involving development, manufacturing, clinical trials, projects from incep�on to comple�on, ensuring �mely delivery of projects)

Our Services

Welcome to ArkGen Pharma!

We currently offer the following services

Note: Products listed here will not be supplied to countries in which these could be in conflict with exis�ng patents.The final responsibility lies exclusively with the buyer.

API Product List# API CAS Number Form Therapeu�c Use

1 CABERGOLINE [81409-90-7] 0.50 mg oral tablet

Lacta�on suppression in hyper-pro-lac�nemia

Treatment of Prolac�n-producing pituitary gland tumors

Treatment of uterine fibroids

Monotherapy in early phase of Parkinson's disease (PD)

Combina�on with Levodopa and Carbidopa in progressive-phase PD

Adjunc�ve therapy of acromegaly

2 LEVOTHYROXINE SODIUM [6893-02-3] 25 µg oral tablet

Treat hypothyroidism

Treat goiter

Thyroid cancer to suppress TSH

Myxedema coma

3 MISOPROSTOL (1% dispersion in HPMC) [745-65-3] 100 mcg or 200 mcg oral and vaginal tablets

Preven�on of NSAID-induced gastric ulcers

Labor induc�on by uterine contrac�ons and thinning of cervix

Medical abor�ons

Missed miscarriage to treat early fetal death

Prevent and treat post-partum bleeding

4 NEPAFENAC (Micronized and Sterile) [78281-72-8]1mg/ml or 3mg/ml ophthalmic

suspensionNSAID to reduce pain, inflamma�on and swelling in the eyes a�er cataract

surgery.

5 PYRIDOXAMINE DI HCL [524-36-7]50 mg, 100 mg, 300 mg oral

tabletsEffec�ve in slowing the progression of Diabetes-induced arterial s�ffening

7 VALGANCICLOVIR HCL [175865-59-5] 450 mg oral film-coated tablets Cytomegalovirus Prophylaxis in Renal Transplanta�on

8 OSELTAMIVIR PHOSPHATE [204255-11-8]75 mg capsule or 6 mg/ml oral

suspensionAn�viral used in treatment of influenza virus types A and B

9 MINOXIDIL SULFATE [83701-22-8] 7% topical solu�on Ac�ve metabolite of Minoxidil used in treatment of androgenic alopecia

10 MINOXIDIL [38304-91-5] 5% topical solu�on Treatment of androgenic alopecia

11 IRON SUCROSE (Pyrogen Free) [8047-67-4] i.v. Or infusionIron replacement product used to treat iron deficiency anemia in pa�ents with

chronic kidney disease (CKD)

12 DOCUSATE SODIUM [577-11-7]100 mg oral tablets or so�gel

capsulesStool so�ener to prevent straining of bowel movement a�er a heart a�ack or

surgery

13 FLUNARIZINE DI HCL [30484-77-6] 5 mg or 10 mg oral tablets and capsules

Calcium channel blocker used in the treatment of dizziness, ver�go and

preven�on of migraine.

14 MICONAZOLE NITRATE [22832-87-7] 2% w/w topical / vaginal cream or oral gel

An�fungal agent applied topically to the skin or to mucous membranes and a

skin condi�on called pityriasis

15 NITAZOXANIDE (Micronized) [55981-09-4]500 mg oral tablet and 100 mg/5ml oral susp.

Broad-spectrum an�parasi�c and broad-spectrum an�viral drug used in

treatment of various helminthic, protozoal, and viral infec�ons.

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Intermediates Product ListS. No. Intermediate Name CAS No. Used for API

1 [651324-08-2] OSELTAMIVIR

2 [1068-90-2] FINGOLIMOD

4 [825643-65-0] NETUPITANT

5 [825643-59-2]

6 [211915-06-9] DABIGATRAN

7 [14328-03-6] PREGABALIN

8 [4698-11-7] OXCARBAZEPINE

9 [2133835-48-8] ACALABRUTINIB

10 [635702-60-2] PAZOPINIB

11

(3R,4R,5S)-4-N-Acetyl(1,1-dimethylethyl)amino-5-N,N-

diallylamino-3-(1-ethylpropoxy)-1-cyclohexene-1-

carboxylic acid ethyl ester mono hydrochloride

Diethyl acetamido malonate

6-Chloro-N-methyl-4-(otolyl)pyridine-3-amine

6-Chloro-4-Iodo-N-methylpyridin-3-amine

Dabigatran etexilate

3-isobutyl-pentanedioic acid dimethyl ester

10-Methoxy Imino-s�lbene

4- [amino (3-chloro-2-pyrazinyl) methyl] -N- (2-pyridyl)

benzamide

2, 3-dimethyl-6-amino-2H-indazole Hydrochloride

4-[4-Methylpiperazin-1-yl]methyl]benzoyl Chloride di

hydrogen chloride[148077-69-4] IMATINIB

NETUPITANT

3 [194154-40-0] VALGANCICOLVIR Mono-benzyloxycarbonyl-L-valine Ganciclovir