Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG Bubendorf CH
02 2ASPEN OSS B.V. Oss NL
03 1TEVA PHARMACEUTICAL INDUSTRIES LTD Petach Tikva IL
04 2BCN PEPTIDES S.A. St Quinti De Mediona ES
05 1CHEMI S.P.A. Patrica IT
06 1HYBIO PHARMACEUTICAL CO., LTD. Shenzhen CN
07 1MALLINCKRODT, INC. Hazelwood US
08 1PIRAMAL PHARMA LIMITED Navi Mumbai IN
09 1PolyPeptide Laboratories (Sweden) AB Limhamn SE
10 1PolyPeptide Laboratories Inc. Torrance US
11 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
12 1Takeda Pharmaceutical Company, Limited Osaka JP
13 1ZHEJIANG PEPTITES BIOTECH CO., LTD. Sanjie Town CN
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Certificate Number : R1-CEP 2001-454 - Rev 01
Status : Valid
Issue Date : 2009-02-18
Type : Chemical
Substance Number : 1442
Aspen API. More than just an API.
Certificate Number : R1-CEP 2016-199 - Rev 00
Status : Valid
Issue Date : 2022-08-26
Type : Chemical
Substance Number : 1442
TAPI offers customized CDMO Solutions for API development and manufacturing services.
Certificate Number : R1-CEP 2006-028 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2015-07-15
Type : Chemical
Substance Number : 1442
Aspen API. More than just an API.
Certificate Number : R0-CEP 2021-472 - Rev 00
Status : Valid
Issue Date : 2022-02-28
Type : Chemical
Substance Number : 1442
A Leuprolide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprolide, including repackagers and relabelers. The FDA regulates Leuprolide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprolide 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 Leuprolide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leuprolide supplier is an individual or a company that provides Leuprolide active pharmaceutical ingredient (API) or Leuprolide finished formulations upon request. The Leuprolide suppliers may include Leuprolide API manufacturers, exporters, distributors and traders.
click here to find a list of Leuprolide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Leuprolide CEP of the European Pharmacopoeia monograph is often referred to as a Leuprolide Certificate of Suitability (COS). The purpose of a Leuprolide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Leuprolide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Leuprolide to their clients by showing that a Leuprolide CEP has been issued for it. The manufacturer submits a Leuprolide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Leuprolide CEP holder for the record. Additionally, the data presented in the Leuprolide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Leuprolide DMF.
A Leuprolide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Leuprolide 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 Leuprolide suppliers with CEP (COS) on PharmaCompass.
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