rivastigmine - pharmacompass · containing rivastigmine against alvogenand focus farma because the...
TRANSCRIPT
RIVASTIGMINEPHARMACOMPASS MARKET OVERVIEW
PharmaCompass.com New Delhi: [email protected]
Paris: [email protected]
PATENT & NEWS
Patent in the US
Novartis’ Exelon has 6 patents for Transdermal Patch (Extended Release) which are set to expire in Jan 2019
PRODUCT OVERVIEW AND
PATENT IN THE U.S.
Overview
Rivastigmine (sold under the trade name Exelon) is a parasympathomimetic or cholinergicAgent.
Synonyms: Exelon™, Rivastigmine tartrate , Rivastach® Patch, Prometax®, SDZ ENA 713
Chemical Name: (S)-3-[1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate
Therapeutic Indication: It is used for the treatment of mild to moderate dementia of the Alzheimer's type and dementia due to Parkinson's disease.
Originator: Novartis
Originator Market: The United States
Developer: Novartis; Ono Pharmaceutical
PATENT & NEWS
Related news and articles
• The Hague District Court rejected Novartis’ claim based on infringement of its patent for patches containing rivastigmine against Alvogen and Focus Farma because the patent was invalid- July 7, 2016
Novartis AG is co-owner of EP 2 292 219 B1 (EP 219), granted on 12 June 2013. EP 219 relates to a “Transdermal therapeutic system for the administration of rivastigmine”
• Novartis has been battling generic-drug makers over the Exelon patch patents in multiple suits over the past few years:- November 6, 2015
(i) Novartis and LTS Lohmann Therapie-Systeme AG claim Dr. Reddy’s and Amneal and its New York and India subsidiaries infringed two patents associated with Exelon
(ii) The brand name drugmaker sued Par Pharmaceuticals and Watson Lab. over the Exelon patch patents in 2013
(iii) A judge ruled that Watson infringed the patents in its ANDA in June 2014 and Par settled, only to go to trial later
(iv) After beating Watson, Novartis took on Mylan Pharmaceuticals in June 2014 as well
(v) Zydus Pharma (USA) also got slapped with an Exelon suit in 2014, but it was thrown out for lack of jurisdiction in August
GLOBAL NEWS
GENERIC LANDSCAPE
U.S. MARKET
Patch
Alvogen Launches the First Generic Exelon® Patch in the United States market -September 04, 2015
Sandoz launches authorized generic version of Exelon® Patch in the United States market -September 2, 2015
Capsules
Sun Pharma introduces generic rivastigmine capsules in the United States market- July 2, 2010
Dr. Reddy’s announces the launch of Rivastigmine Tartrate Capsules in the United States market -September 22, 2011
Generic overview: detailed description here
PRODUCT SALES INFORMATION U.S. MARKET
Capsules generics are on the rise
Sales Data from Annual Reports 2015
COMPANY NAME
PRODUCT NAME
ACTIVE INGREDIENT
MAIN THERAPEUTIC INDICATION
2014 REVENUE IN MILLIONS
2015 REVENUE IN MILLIONS
SALES DIFFERENCE IN MILLIONS GROWTH
(%)(USD) (USD) (USD)Novartis Exelon Caps/
Exelon PatchRivastigmine Neuroscience and
Mental Health 1,009 728 -281 -28%
DRUG NAME GENERIC NAME BENEFICIARIES PRESCRIPTIONS CLAIMS TOTAL DRUG COST
Exelon Rivastigmine Patch 235,060 78,098 1,381,768 $465,772,265.79Exelon Rivastigmine Tartrate Capsules 1,092 1,129 3,704 $1,395,838.32
Rivastigmine Rivastigmine Tartrate Capsules 51,762 36,189 333,686 $54,729,264.75
Sales Data from U.S. Medicare Prescription Payment in 2013
Sales 2011 from IMS dataEXELON®* brand and generic Rivastigmine tartrate had U.S. sales of approximately $92.6 million forthe most recent twelve months ending June 2011.
Sales 2014 from IMS dataNovartis’s Exelon® patch, delivered sales of approximately $400 million USD in the United States during 2014.
Exelon® Patch is the first and only patch to treat all stages of Alzheimer's disease
Market Size : $ 26.7 million global sales of Rivastigmine in 2015 (as per IMS Data)
Market share: 9 %As per U.S. Medicare Prescription (2013):Capsules sales : 11 %Patch Sales: 89 %
GLOBALAPI SUPPLIERLANDSCAPE
Regulatory Filings(US DMF, CEP/COS,
EU Written Confirmation)
[1/3]
S. NO.
COMPANY NAME COUNTRY ACTIVE INGREDIENTS ALL COMBINED
US DMF CEP/COS
WRITTEN CONFIRMATION
COMPLIANCE ISSUES
1 Aarti Drugs Ltd India Rivastigmine Hydrogen Tartrate Filed ( 2009) - Issued (2013) Import Alert(23-3-2015)
2 Actavis Group Ptc Ehf Ireland Rivastigmine Hydrogen Tartrate Filed ( 2009) - - -
3 Alembic Pharmaceuticals Ltd
India Rivastigmine Filed ( 2015) Issued (2015) Issued (2013) -
Rivastigmine Tartrate Filed ( 2008) - - -
Rivastigmine Hydrogen Tartrate - Issued (2014) - -
4 Apotex Pharmachem Inc Canada Rivastigmine Filed ( 2015) -- Warning Letter
(30/01/15)Rivastigmine Tartrate Filed ( 2008) -
5 Aurobindo Pharma Ltd India Rivastigmine Filed ( 2015) -
Rivastigmine Tartrate Filed ( 2010) - - -
Rivastigmine Hydrogen Tartrate - Issued ( 2015) - -
6 Cadila Healthcare Ltd India Rivastigmine Filed ( 2013) - Issued (2013) -
7 Cambrex Karlskoga Ab United States
Rivastigmine Filed ( 2015) Issued (2016) - -
Rivastigmine Hydrogen Tartrate - Issued (2016) - -
8 CentaurPharmaceuticals
India Rivastigmine Hydrogen Tartrate - - Issued (2016) -
9 Cipla Ltd India Rivastigmine Hydrogen Tartrate Filed ( 2003) Issued (2015) Issued (2013) -
10 Dr Reddys Laboratories Ltd
India Rivastigmine Filed ( 2012) - Issued (2013) Warning Letter
(11/05/15)
Rivastigmine Tartrate - - Issued (2016) -
Rivastigmine Hydrogen Tartrate Filed( 2004) (2008)
Issued (2015) Issued (2016 -
GLOBALAPI SupplierLandscape
with DMF & COS[2/3]
S. NO.
COMPANY NAME COUNTRY ACTIVE INGREDIENTS ALL COMBINED
US DMF CEP/COS
WRITTEN CONFIRMATION
COMPLIANCE ISSUES
11 Erregierre Spa Italy Rivastigmine Filed ( 2011) - - -
Rivastigmine Tartrate Filed ( 2007) - - -
12 Excella Gmbh De 90537 Feucht
Germany Rivastigmine - Issued (2015) - -
13 Interquim Sa Spain Rivastigmine Filed ( 2009) Issued (2015) - -
Rivastigmine Hydrogen Tartrate
- Issued (2015) - -
14 Jubilant Generics Ltd India Rivastigmine Filed ( 2011) - - -
Rivastigmine Tartrate Filed ( 2011) - - -
15 MacleodsPharmaceuticals Ltd
India Rivastigmine Tartrate Filed ( 2010) - - -
16 MSN Organics Private Ltd
India Rivastigmine Filed ( 2015) - - -
Rivastigmine Tartrate Filed ( 2014) - - -
Rivastigmine Hydrogen Tartrate
- Issued (2016) - -
17 Mylan Laboratories Ltd United States
Rivastigmine Filed( 2010) (2012)
Issued (2015) Issued (2013) -
Rivastigmine Tartrate Filed ( 2010) - -
Rivastigmine Hydrogen Tartrate
- Issued (2014) Issued (2013)
18 Nuray Chemicals Pvt. Ltd.,
India Rivastigmine Hydrogen Tartrate
- - Issued (2014) -
GLOBALAPI SUPPLIERLANDSCAPE
Regulatory Filings(US DMF, CEP/COS,
EU Written Confirmation)
[2/3]
GLOBALAPI SupplierLandscape
with DMF & COS[3/3]
S. NO.
COMPANY NAME COUNTRY ACTIVE INGREDIENTS ALL COMBINED
US DMF CEP/COS
EU WRITTEN CONFIRMATION
COMPLIANCE ISSUES
19 Orchid Chemicals And Pharmaceuticals Ltd
India Rivastigmine - - Issued (2013) -
Rivastigmine Tartrate Filed ( 2007) - Issued (2013) -
20 Shodhana Laboratories Ltd.
India Rivastigmine - - Issued (2013) -
Rivastigmine Hydrogen Tartrate
- - Issued (2013) -
21 Sun Pharmaceutical Industries Ltd
India Rivastigmine Tartrate Filed ( 2004) - Issued (2013) -
22 Zhejiang JiuzhouPharmaceutical Co., Ltd. CN 318 000 Taizhou City
China Rivastigmine - Issued (2015)
- -
Conclusion: Total API Suppliers= 22
API Suppliers for :India # 14 (i.e. more than 50%) United States # 2Canada # 1China # 1Germany # 1Italy # 1Ireland # 1Spain # 1
GLOBALAPI SUPPLIERLANDSCAPE
Regulatory Filings(US DMF, CEP/COS and
EU Written Confirmation)
[3/3]
GLOBALAPI SUPPLIERLANDSCAPE
Others
Other Suppliers in various databases
Rivastigmine Bioiberica S.A (CPHI China Exhibitor Product List) Hangzhou Read Chemical Co.,Ltd. (CPHI China Exhibitor Product List) Hubei Lansun Biochemistry Pharmaceutical Co., Ltd. (CPHI China Exhibitor Product List) Interquim, S.A. *(New Zealand Database) Mylan Laboratories Limited *(New Zealand Database) Novartis Pharma AG *(New Zealand Database) Novartis Ringaskiddy Ltd *(New Zealand Database) Shenzhen Oriental Pharmaceutical Co., Ltd. (CPHI China Exhibitor Product List)
Rivastigmine Tartrate Alembic Pharmaceuticals Limited, Unit I (Mexico COFEPRIS Database ) Bharat Pharma (Product List) BOC Sciences (Product List) Cipla Ltd (New Zealand Database) Dalian Wondersun Biochemical Technology Co,.Ltd (CPHI China Exhibitor Product List) Globe Quimica Ltda (Product List) Hangzhou Neway Chemicals Co.,Ltd (CPHI China Exhibitor Product List) Langfang Gaobo Jingband Pharmaceutical Co.,Ltd. (CPHI China Exhibitor Product List)
Rivastigmine Hydrogen Tartrate Aarti Drugs Limited Cipla Ltd (Iran API Registration ) Interquim (Iran API Registration ) Sun Pharmaceutical (Iran API Registration )
* Manufacturer for both Rivastigmine and Rivastigmine Tartrate
EGYPT MARKET CUSTOMERS SUPPLIERS
LANDSCAPE
Commercial opportunity for Multinational Pharmaceutical
Companies • Egypt' s pharmaceutical and healthcare sector presents a high-risk investment opportunityfor international drug makers
• Egypt finished dosage formulators import API majorly from India and China
COMPANY NAME (SUPPLIERS) COUNTRY CUSTOMERS IN EGYPT
Aarti Drugs Limited India Al Esraa Pharmaceutical Optima-egypt
Dr Reddy's Laboratories Ltd India Global NAPI Pharmaceuticals (GNP), Hikma pharmaEmcure Pharmaceutical Limited India Global NAPI Pharmaceuticals (GNP)
Interquim S.A-spain Spain Eva pharma for Pharmaceuticals and Medical Appliances
Mahavir Laboratories Private Ltd India Arab Company for Pharmaceuticals & Medicinal Plants (Mepaco- Medi Food)
MSN Organics P Ltd India universal pharmceutical industries (unipharma)
Shodhana Laboratories Ltd India Mash Company For Pharmaceutical Industries (Mash Premiere)
Sun Pharmaceutical Industries-india India Eva pharma for Pharmaceuticals and Medical Appliances
Shanghai Daishang Chemical Co.,Ltd-china China Mash Company For Pharmaceutical Industries (Mash Premiere)
Zhengzhou Sigma Chemical Co.Ltd-china China Mash Company For Pharmaceutical Industries (Mash Premiere)
Zhiyu Biotechnology Co,ltd-china China Mash Company For Pharmaceutical Industries (Mash Premiere)
Conclusion:
COMPETITOR ANALYSIS
API Trade Statistics
[1/2]
Major destinations from where API has been Imported are :
IMPORTING PORT QUANTITY(KGS) CIF ($) AVG. PRICE
($/KGS)
Spain 5.5 44,455.0 8,082.7
Ahmedabad 5.5 44,455.0 8,082.7Slovak Republic 1.0 3,349.0 3,349.0
Mumbai Air 1.0 3,349.0 3,349.0
Imported by Rusan Pharma from Slovak Republic
(Highly possibility that the supplier is Saneca)
The United States16.2gms of API was imported for USD 132,475. Possible suppliers can be Mylan US or CambrexKarlskoga
France11gms of API was imported for USD 9,844
Imported by Zydus Cadila from Spain(Highly possibility that the supplier is Interquim)
API Imports to India from Jan 2015- Mid 2016
From Jan 2015- Mid 2016,Less than 10 Kg API has been
imported into India
API Exports of India from Jan 2015- Mid 2016
EXPORTING PORTDESTINATION IN INDIA
QUANTITY (KGS) CIF ($) AVG. PRICE
($/KGS)Seoul - Incheon Int' 1,027 3,904,116 3,801.5
Mumbai Air 999 3,767,068 3,771.2Hyderabad Air 24 123,926 5,163.6Ahmedabad 4 13,122 3,200.5
Boston - Logan, Ma 591 1,897,779 3,206.3Mumbai Air 591 1,897,779 3,206.3
Philadelphia 421 1,346,487 3,196.6Mumbai Air 421 1,346,487 3,196.6
Guarulhos 221 732,501 3,314.5Ahmedabad 120 383,935 3,199.5Mumbai Air 101 348,566 3,451.1
Reykjavik 85 297,485 3,499.8Mumbai Air 47 159,164 3,386.5Ahmedabad 38 138,321 3,640.0
Tehran 71 255,219 3,594.1Mumbai Air 71 255,219 3,594.1
Total Export Of API - 2,653 Kg/ USD 9,650,590
Export of different salts of API mentioned below-
Rivastigmine: 2,090 Kg/ USD 7,261,356Rivastigmine Tartrate: 368 Kg/ USD 1,320,979Rivastigmine Hydrogen Tartrate: 198 Kg/ USD 1,068,947
Alembic Pharmaceuticals exported 197 Kg/ USD 660,215 API from Ahmedabad as per the transaction data
Hyderabad exported 67 Kg/ USD 309,044 API ; possible supplier can be Aurobindo Pharma, MSN organic, Hetero Drugs, Shodhana Laboratories as per the transaction data
Bangalore exported 14 Kg/ USD 32,713 API
API exported by Mumbai - 2,375 Kg/ USD 8,648,618
Mylan (Mumbai) exported 814 Kg/ USD 2,625,032 Other exports are of Oceanic Pharmachem
[104 Kg/ 400891] and Cipla based on transaction data Centaur Pharma, Macleods , Sun Pharmaceuticals
can be other possible suppliers from MumbaiExported by Emcure to Marham Daru, Iran
Major destinations where API has been exported are :
Conclusion: API export of India (2,552Kgs) has been almost 365 times compare to the API import (7Kgs) to India
From Jan 2015-Mid 2016;
COMPETITOR ANALYSIS
API Trade Statistics
[2/2]
Major destinations from where FDF has been imported are:
From Jan 2015-Mid 2016; USD 2,003,303 FDF has been imported
Transdermal Patch CapsulesUSD1,804,522 USD198,781
Rivastigmine Transdermal patch was imported by Novartis India, Possible supplier from Spain can be Novartis Farmaceutica as per the list of Imported finished formulation (registered) (June 2014- Dec. 2014
which is valid till 2017) issued by CDSCO (India)
Rivastigmine capsules was imported by Novartis India, Possible supplier from Germany can be M/S Lts Lohmanni as per the list
of Imported finished formulation (registered) (June 2014- Dec. 2014 which is valid till 2017) issued by CDSCO (India)
Actavis Pharma Development Centre (Chennai) imported Capsules from Iceland
IMPORTING PORTDESTINATION IN INDIA CIF ($)
Spain 1,162,336
Bombay Air Cargo 881,879
Mumbai Air 280,457
Germany 600,371
Mumbai Air 600,371
Iceland 198,781
Chennai Air Cargo 187,578
Chennai Air 11,203
Japan 21,256
Bombay Air Cargo 16,912
Ahmedabad 4,344
United States 20,329
Mumbai Air 20,329
France 230
Bangalore Air 230
GRAND TOTAL 2,003,303
FDF Imports to India from Jan 2015- Mid 2016
Mumbai imported USD 1,799,948 Exelon Patch
Lupin and Cliantha Research, India are among the few importers who imported Rivastigmine Transdermal Patch from Japan
Sidmak Laboratories, India imported USD 4,170 Exelon patch from the United States
COMPETITOR ANALYSIS
FDF Trade Statistics
[1/2]
Major destinations from where FDF has been exported:
EXPORTING PORT CIF ($)
Chicago, Il 2,647,080Detroit Mi 1,547,854Miami, Fl 992,421Prague - Ruzyne 672,825Wixom 632,110Kuala Lumpur 397,471Helsinki 230,798Brownsburg 168,451Chicago 146,005London Metropolitan 111,544Stuttgart 106,071
From Jan 2015-Mid 2016; USD 8,112,264 FDF has been exported
Capsules Patch USD 8,112,109 USD 155
Mumbai exported USD 6,155,118 capsules Hyderabad exported USD 1,937,414 capsules
Ahmedabad exported USD 7,400 capsules
FDF Exports of India from Jan 2015- Mid 2016
Summary of FDF exports of India:
Mylan Laboratories, India exported USD 437,033 Rivastigmine Capsules to Medis International A S, Serbia Mind (Torrent Pharmaceuticals), India exported USD 429,979 capsules (Brand Name: Rivadem) Macleods Pharmaceuticals, India exported USD 343,710 capsules to Macleods Pharmaceuticals USA as per the
transaction data Sun Pharmaceuticals, India exported USD 266,480 capsules (Brand Name: Rivamer and Rivastigmine Tartrate) Torrent Pharmaceuticals, India exported USD 230,798 capsules (Brand Name: Rivastigmin Orion) to Orion
Corp, Finland Dr. Reddy, India exported USD 1,612,049 capsules to Dr. Reddy’s, United States Pharmascience exported USD 19,194 capsules (Brand Name: PMS- rivastigmine) Zydus exported USD 18,274 capsules out of India
Conclusion: India exported USD 8,112,264 FDF which is almost 4 times compare to the FDF import (USD 2,003,303)
COMPETITOR ANALYSIS
FDF Trade Statistics
[2/2]
GLOBALFINISHED DOSAGE
FORMULATORS
[1/5]
COMPANY NAME COUNTRY WEBSITEGenericon Pharma Gesellschaft M.B.H Austria http://www.genericon.at/STADA Arzneimittel Gmbh Austria http://www.stada.at/unternehmen/stada-arzneimittel-gmbh/Enestia Belgium N.V / S.A. Belgium http://www.sharpservices.com/Eurogenerics N.V Belgium http://www.eg.be/nlNovartis (Bangladesh) Ltd. BangladeshSun Pharmaceutical (Bangladesh) Ltd. Bangladesh http://www.sunpharma.com/Apotex Inc Canada http://www.apotex.com/global/default.aspGeneric Medical Partners Inc Canada http://www.gmprx.com/Site/Home.htmlMint Pharmaceuticals Inc Canada http://www.mintpharmaceuticals.com/English/index.phpNovopharm Ltd Canada https://www.tevacanada.com/default.aspxPharmascience Inc Canada http://www.pharmascience.com/homePro Doc Limitee Canada http://www.prodoc.qc.ca/S & D Pharma CZ , Spol . S.R.O Czech Republic http://www.sdpharma.cz/Orifarm Generics A / S, Denmark Denmark http://www.orifarm.com/Pharmacodane Aps Denmark http://pharmacodane.dk/Al Esraa Pharmaceutical Optima Egypt http://esraapharma.com/hcp/Eva Pharma For Pharmaceuticals And Medical Appliances Egypt http://www.evapharma.com/Mash Company For Pharmaceutical Industries Egypt http://www.mashpharma.com/Mepaco-medifood Egypt http://www.mepaco-pharma.net/Unipharma Co. Egypt http://www.unipharma-eg.com/Western Pharmaceuticals Industries Egypt http://www.western-pharmaceutical.com/index.htmlDelpharm Huningue SAS France http://www.delpharm.com/Delpharm-HuningueLaboratoires Plasto Sante France http://www.plastopharma.com/TEVA Santé France http://www.teva-france.fr/Pages/default.aspxZydus France France http://www.zydusfrance.com/ACC Gmbh Analytical Clinical Concepts Germany http://www.accgmbh.com/en/index.htmlAliud Pharma Gmbh & Co. Kg Germany http://www.aliud.de/AMW Gmbh Germany https://a-m-w.eu/en/Betapharm Arzneimittel Gmbh Germany http://www.drreddys.com/germany/dr-reddys-in-germany.aspxGenus Pharmaceuticals Ltd Germany http://www.thorntonross.co.uk/Hexal AG Germany http://www.hexal.de/Lek Pharmaceuticals D.D Germany http://www.lek.si/en/Lts Lohmann Therapie Systeme Ag Germany http://www.ltslohmann.de/en/home.htmlMerckle GMBH Germany http://www.merckle.de/Neuraxpharm Arzneimittel Gmbh Germany http://www.neuraxpharm.de/html-de/start.php
GLOBALFINISHED DOSAGE
FORMULATORS
[2/5]
COMPANY NAME COUNTRY WEBSITENovartis Pharma Gmbh Germany https://www.novartis.de/PHAST Society For Pharmaceutical Quality Standards Mbh Germany http://www.phast.com/index.htmlSalutas Pharma Gmbh Germany http://www.sandoz.de/salutas/Stada Arzneimittel Ag Germany https://www.stada.com/start.htmlTorrent Pharma Gmbh Germany http://www.torrentpharma.com/int_europe.phpWelding Gmbh & Co. Kg Germany http://welding.eu/en/Winthrop Arzneimittel Gmbh Germany https://www.zentiva.de/Genepharm Sa Greece http://www.genepharm.gr/en/Global Napi Pharmaceuticals Greece http://www.globalnapi.com/Heumann Pharma Gmbh & Co. Generica KG Greece https://www.heumann.de/Kleva Pharmaceuticals SA GreeceLavipharm SA Greece http://www.lavipharm.gr/Pharmanel Pharmaceuticals SA, Greece http://www.pharmanel.gr/Pharmathen Greece http://www.pharmathen.com/home/home-27.htm?lang=enSpecifar S.A Greece http://www.specifar.gr/Vianex S.A Greece http://www.vianex.gr/Mylan Hungary Kft. Hungary http://www.mylan.co.hu/hu-hu/kapcsolatfelvetel-mylanActavis Group PTC Ehf Iceland http://www.actavis.co.uk/en-gb/homeAurochem Pharmaceuticals (India) Pvt. Ltd India http://www.aurochemlaboratories.com/Alembic Pharmaceuticals Limited IndiaCipla Ltd India http://www.cipla.com/en/Mylan Laboratories Limited India http://www.mylan.in/Orchid Healthcare (Una División De Orchid Chemicals & Pharmaceuticals Ltda.) De India India http://www.orchidpharma.com/Default.aspxVeros Healthcare Pvt . Ltd . De India India http://www.verospharma.com/Mcdermott Laboratories Limited Ireland http://www.mylan.ie/en-ie/contact-mylanSuir Pharma (Formerly A Stada AG Manufacturing Site) Ireland http://www.suirpharma.com/Jeil Pharmaceutical Co., Ltd. Korea https://www.jeilpharm.co.kr/eng/Myungmoon Pharm. Co., Ltd Korea http://www.mmpharm.co.kr/APL Swift Services (Malta) Limited Malta http://www.aurobindo.com/Milpharm Limited Malta http://www.aurobindo.com/Centrafarm Services B.V. Netherlands http://www.centrafarm.nl/Focus Farma Netherlands http://www.focusfarma.nl/
Teva Pharma B.V Netherlandshttp://www.tevapharm.com/teva_worldwide/europe/teva_in_netherlands/
GLOBALFINISHED DOSAGE
FORMULATORS
[3/5]
COMPANY NAME COUNTRY WEBSITETjoapack Netherlands BV Netherlands http://tjoapack.com/Douglas Pharmaceuticals (Fiji) Limited New Zealand http://www.douglaspharmaceuticals.com/en/Douglas Manufacturing Ltd New Zealand http://www.douglasmanufacturing.co.nz/en/ICN Polfa Rzeszów S.A. Poland http://www.icnpolfa.pl/enJelfa SA Poland http://www.valeant.eu/contact/jelfa-saPabianice Polfa SA Poland http://med-interplast.com/producers/10.htmlTeva Operations Poland Sp . Z O.O. Poland http://www.teva.pl/Pages/default.aspxValeant Sp. Z O.O. Sp. J. Poland http://www.valeantinfo.pl/en
Farma-aps Pharmaceuticals, SA Portugal http://www.atlasdasaude.pt/publico/content/farma-aps-produtos-farmaceuticos-sa
S.C. Rompharm Company S.R.L. Romania http://www.rompharm.ro/HBM Pharma S.R.O. Slovak Republic http://www.hbmpharma.eu/en/main/indexKrka, D. D., Novo Mesto slovenia https://www.krka.biz/en/Cinfa Laboratories, Sa Spain http://www.cinfa.com/cinfa/home/inicio.aspxKern Pharma Spain http://www.kernpharma.com/enLaboratorios Medicamentos Internacionales S.A Spain http://www.medinsa.es/Laboratorios Vir S.A. Spain http://vir.es/index.php/en/Labosuan Spain http://www.labosuan.com/en/Lacer S.A Spain http://www.lacer.es/wps/portal/wp/lacerNovartis Farmacéutica, S.A Spain https://www.novartis.es/Acino Ag Switzerland http://www.acino-pharma.com/html/index.php?id=1&L=1Novartis Pharma-switzerland Switzerland https://www.novartis.com/Novartis (Thailand) Ltd Thailand www.th.novartis.comWorld Medicine Ilac San Ve Tic LTD Stl Turkey http://www.worldmedicinegroup.com/Bristol Laboratories Limited United Kingdom http://www.bristol-labs.co.uk/Generics [UK] Ltd United Kingdom http://www.mylan.co.uk/Hikma Pharma United Kingdom http://www.hikma.com/en/index.htmlNicobrand Limited United Kingdom http://www.nicobrand.com/Rosemont Pharmaceuticals Ltd United Kingdom https://www.rosemontpharma.com/
GLOBALFINISHED DOSAGE
FORMULATORS
[4/5]
Watson Labs [NDC No. 0591-3208-60] is getting the USFDA approved product manufactured in India by Cipla based on the Label
Alvogen is getting the USFDA approved product manufactured in Germany by Acino AG on the basis of NDC No. 47781-304-03 (mentioned on Medlibrary)
GLOBALFINISHED DOSAGE
FORMULATORS
[5/5]
Breckenridge Pharmaceutical [NDC No. 51991-793-33] is getting the USFDA approved product manufactured in India by Alembic Pharmaceuticals based on the Label
Sun Pharmaceuticals Industries, US[NDC 62756-145-86] is getting the USFDA approved product manufactured in India by Sun Pharmaceuticals India based on the label
OPPORTUNITIES TO
CONSIDER
NO GENERICS PRESENT IN BELOW MENTIONED COUNTRIES
Arab Emirates, Bahrain, China, Costa Rica, Colombia, Lebanon, Mexico, Saudi Arabia, Singapore, Sudan, Taiwan
NOT LAUNCHED IN BELOW MENTIONED COUNTRIES
Guatemala, Vietnam
OPPORTUNITY FOR API MANUFACTURER IN MENTIONED COUNTRIES
MEXICOAlembic Pharmaceuticals Limited, Unit I is the only API manufacturer
IRANCipla, Interquim and Sun Pharmaceutical are the API manufacturer
JAPANNo JPDMF fillings