Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1PHARMACEUTICAL WORKS POLPHARMA S.A. Starogard Gdanski PL
02 1SANOFI İLAÇ SANAYI VE TICARET A.Ş. Istanbul TR
03 1Medichem, S.A. Sant Joan Despà ES
04 1ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN
05 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
06 1CADILA PHARMACEUTICALS LIMITED Ankleshwar IN
07 1CHONGQING CARELIFE PHARMACEUTICAL CO., LTD. Chongqing CN
08 1CIPLA LIMITED Mumbai IN
09 1DR. REDDY'S LABORATORIES LIMITED Hyderabad IN
10 1GEDEON RICHTER PLC Budapest HU
11 1IPCA Laboratories Limited Mumbai IN
12 1JUBILANT PHARMOVA LIMITED Nanjangud IN
13 1Merck Sharp & Dohme (Europe) Inc. Brussels BE
14 1Shijiazhuang Pharmaceutical Group, Huasheng Pharma Co., Ltd. Shijiazhuang CN
15 1TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN
01 14Sodium alendronate trihydrate
02 1Sodium alendronate trihydrate, Milled
01 2China
02 1France
03 1Hungary
04 8India
05 1Poland
06 1Spain
07 1U.S.A
01 1Expired
02 11Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 2Withdrawn by Holder
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Certificate Number : R1-CEP 2003-273 - Rev 04
Status : Valid
Issue Date : 2021-05-12
Type : Chemical
Substance Number : 1564
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2004-215 - Rev 04
Status : Valid
Issue Date : 2019-01-04
Type : Chemical
Substance Number : 1564
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Certificate Number : R1-CEP 2010-273 - Rev 00
Status : Valid
Issue Date : 2016-10-13
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2008-230 - Rev 04
Status : Valid
Issue Date : 2022-09-14
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2005-126 - Rev 04
Status : Valid
Issue Date : 2018-08-29
Type : Chemical
Substance Number : 1564
Sodium Alendronate Trihydrate, Milled
Certificate Number : R1-CEP 2004-095 - Rev 04
Status : Valid
Issue Date : 2020-08-19
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2008-090 - Rev 02
Status : Valid
Issue Date : 2021-04-27
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2011-111 - Rev 01
Status : Valid
Issue Date : 2022-08-24
Type : Chemical
Substance Number : 1564
Certificate Number : CEP 2009-290 - Rev 02
Status : Valid
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 1564
Certificate Number : R1-CEP 2008-192 - Rev 01
Status : Valid
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 1564
A Fosamax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosamax, including repackagers and relabelers. The FDA regulates Fosamax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosamax API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Fosamax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosamax supplier is an individual or a company that provides Fosamax active pharmaceutical ingredient (API) or Fosamax finished formulations upon request. The Fosamax suppliers may include Fosamax API manufacturers, exporters, distributors and traders.
click here to find a list of Fosamax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosamax CEP of the European Pharmacopoeia monograph is often referred to as a Fosamax Certificate of Suitability (COS). The purpose of a Fosamax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fosamax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fosamax to their clients by showing that a Fosamax CEP has been issued for it. The manufacturer submits a Fosamax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fosamax CEP holder for the record. Additionally, the data presented in the Fosamax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fosamax DMF.
A Fosamax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fosamax CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Fosamax suppliers with CEP (COS) on PharmaCompass.
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