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RIVASTIGMINE, RIVASTIGMINE TARTRATE
A PHARMACOMPASS BUSINESS INTELLIGENCE REPORT - 2016
PharmaCompass.com
New Delhi: [email protected]
Paris: [email protected]
PATENT & NEWS
Patents in the U.S.
Novartis’ Exelon has 6 patents for Transdermal Patch (Extended Release)
First Patent Expiry -Jan 2019
PRODUCT OVERVIEW
&
U.S. PATENTS
Overview
Rivastigmine (sold under the trade name Exelon) is a parasympathomimetic or cholinergic agent
Synonyms:Exelon™, Rivastigmine tartrate , Rivastach® Patch, Prometax®, SDZ ENA 713
Chemical Name:(S)-3-[1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate
Originator: Novartis ; Ono Pharmaceutical
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.
Chemical Structure
BRAND/GENERICS
LANDSCAPE
U.S. MARKET
Patch
Capsules
BRAND:
GENERICS:
Exelon® Patch is the first and only patch to treat all stages of Alzheimer's disease
PRODUCT SALES INFORMATION U.S. MARKET
Capsules generics are on the rise
Sales Data from Annual Report 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 Patch
Rivastigmine 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 $465,772,265.79
Exelon 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 Data 2011 from IMS
EXELON®* brand and generic Rivastigmine tartrate had U.S. sales of approximately $92.6 million for the most recent twelve months ending June 2011
Sales Data 2014 from IMS
Novartis’s Exelon® patch, delivered sales of approximately $400 million USD in the United States in 2014
Market Size : $ 26.7 million global sales of Rivastigmine in 2015 (IMS Data)
Market share: 9 %
As per U.S. Medicare Prescription (2013):Capsules sales : 11 %Patch Sales: 89 %
PATENT & NEWS
Recent 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
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
Other Databases
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 )
* Manufacturers for both Rivastigmine and Rivastigmine Tartrate
EGYPTIAN MARKET
CUSTOMERS/SUPPLIERS LANDSCAPE
Mash Premiere Leading Buyer of Rivastigmine
• 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 pharma
Emcure Pharmaceutical Limited India Global NAPI Pharmaceuticals (GNP)
Interquim S.A-spain Spain Eva pharma for Pharmaceuticals and Medical Appliances
Mahavir Laboratories Private Ltd IndiaArab Company for Pharmaceuticals & Medicinal Plants (Mepaco- Medi Food)
MSN Organics P Ltd India Universal pharmceutical industries (unipharma)
Shodhana Laboratories Ltd IndiaMash Company For Pharmaceutical Industries (Mash Premiere)
Sun Pharmaceutical Industries-india India Eva pharma for Pharmaceuticals and Medical Appliances
Shanghai Daishang Chemical Co.,Ltd-china ChinaMash Company For Pharmaceutical Industries (Mash Premiere)
Zhengzhou Sigma Chemical Co.Ltd-china ChinaMash Company For Pharmaceutical Industries (Mash Premiere)
Zhiyu Biotechnology Co,ltd-china ChinaMash Company For Pharmaceutical Industries (Mash Premiere)
Conclusion:
COMPETITOR ANALYSIS
API Trade Statistics
[1/3]
IMPORTING PORTQUANTITY
(KGS)CIF ($)
AVG. PRICE ($/KGS)
Spain 5.5 44,455.0 8,082.7
Ahmedabad 5.5 44,455.0 8,082.7
Slovak Republic 1.0 3,349.0 3,349.0
Mumbai Air 1.0 3,349.0 3,349.0
Major destinations from where API has been Imported are :
Imported by Rusan Pharma from Slovak Republic
(High possibility that the supplier is Saneca)
Imported by Zydus Cadila from Spain
(High 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 3,801.5Mumbai Air 999 3,767,068 3,771.2
Hyderabad Air 24 123,926 5,163.6
Ahmedabad 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 3,199.5
Mumbai Air 101 348,566 3,451.1
Reykjavik 85 297,485 3,499.8Mumbai Air 47 159,164 3,386.5
Ahmedabad 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 7,261,356
Rivastigmine Tartrate-368 Kg/ USD 1,320,979
Rivastigmine Hydrogen Tartrate-198 Kg/ USD 1,068,947
Exported by Emcure to Marham Daru, Iran
Major destinations where API has been exported are :
From Jan 2015-Mid 2016; COMPETITOR
ANALYSIS
API Trade Statistics
[2/3]
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
Conclusion: Mylan, Alembic, Oceanic Pharmachem are the major exporters
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 available transaction data
Centaur Pharma, Macleods , Sun Pharmaceuticals can be other possible suppliers from Mumbai
COMPETITOR ANALYSIS
API Trade Statistics
[3/3]
Brief Analysis of API Exports of India from Jan 2015- Mid 2016
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)
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)
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 2,647,080
Detroit Mi 1,547,854
Miami, Fl 992,421
Prague - Ruzyne 672,825
Wixom 632,110
Kuala Lumpur 397,471
Helsinki 230,798
Brownsburg 168,451
Chicago 146,005
London Metropolitan 111,544
Stuttgart 106,071
From Jan 2015-Mid 2016; USD 8,112,264 FDF has been exported
Capsules PatchUSD 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 more than USD 8 million of Rivastigmine FDF
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/nl
Novartis (Bangladesh) Ltd. Bangladesh
Sun Pharmaceutical (Bangladesh) Ltd. Bangladesh http://www.sunpharma.com/
Apotex Inc Canada http://www.apotex.com/global/default.asp
Generic Medical Partners Inc Canada http://www.gmprx.com/Site/Home.html
Mint Pharmaceuticals Inc Canada http://www.mintpharmaceuticals.com/English/index.php
Novopharm Ltd Canada https://www.tevacanada.com/default.aspx
Pharmascience Inc Canada http://www.pharmascience.com/home
Pro 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.html
Delpharm Huningue SAS France http://www.delpharm.com/Delpharm-Huningue
Laboratoires Plasto Sante France http://www.plastopharma.com/
TEVA Santé France http://www.teva-france.fr/Pages/default.aspx
Zydus France France http://www.zydusfrance.com/
ACC Gmbh Analytical Clinical Concepts Germany http://www.accgmbh.com/en/index.html
Aliud 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.aspx
Genus 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.html
Merckle 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.html
Salutas Pharma Gmbh Germany http://www.sandoz.de/salutas/
Stada Arzneimittel Ag Germany https://www.stada.com/start.html
Torrent Pharma Gmbh Germany http://www.torrentpharma.com/int_europe.php
Welding 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 Greece
Lavipharm 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=en
Specifar 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-mylan
Actavis Group PTC Ehf Iceland http://www.actavis.co.uk/en-gb/home
Aurochem Pharmaceuticals (India) Pvt. Ltd India http://www.aurochemlaboratories.com/
Alembic Pharmaceuticals Limited India
Cipla 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.aspx
Veros Healthcare Pvt . Ltd . De India India http://www.verospharma.com/
Mcdermott Laboratories Limited Ireland http://www.mylan.ie/en-ie/contact-mylan
Suir 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/en
Jelfa SA Poland http://www.valeant.eu/contact/jelfa-sa
Pabianice Polfa SA Poland http://med-interplast.com/producers/10.html
Teva Operations Poland Sp . Z O.O. Poland http://www.teva.pl/Pages/default.aspx
Valeant 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/index
Krka, D. D., Novo Mesto slovenia https://www.krka.biz/en/
Cinfa Laboratories, Sa Spain http://www.cinfa.com/cinfa/home/inicio.aspx
Kern Pharma Spain http://www.kernpharma.com/en
Laboratorios 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/lacer
Novartis Farmacéutica, S.A Spain https://www.novartis.es/
Acino Ag Switzerland http://www.acino-pharma.com/html/index.php?id=1&L=1
Novartis Pharma-switzerland Switzerland https://www.novartis.com/
Novartis (Thailand) Ltd Thailand www.th.novartis.com
World 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.html
Nicobrand 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 THE COUNTRIES MENTIONED BELOW
Arab Emirates, Bahrain, China, Costa Rica, Colombia, Lebanon, Mexico, Saudi Arabia, Singapore, Sudan, Taiwan
NOT LAUNCHED IN THE COUNTRIES MENTIONED BELOW
Guatemala, Vietnam
OPPORTUNITIES FOR API MANUFACTURERS
MEXICO
Alembic Pharmaceuticals Limited, Unit I is the only API manufacturer
IRAN
Cipla, Interquim and Sun Pharmaceutical are the API manufacturer
JAPAN
No JPDMF fillings
