01 1DSM Nutritional Products Ltd. Kaiseraugst CH
02 1ZHEJIANG SHENGDA BIO-PHARM CO., LTD. Tiantai CN
01 2Biotin
01 1China
02 1Switzerland
01 2Valid
Certificate Number : CEP 2001-405 - Rev 06
Status : Valid
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 1073
Certificate Number : R0-CEP 2019-320 - Rev 00
Status : Valid
Issue Date : 2021-08-09
Type : Chemical
Substance Number : 1073
A Biotin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biotin, including repackagers and relabelers. The FDA regulates Biotin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biotin 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 Biotin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biotin supplier is an individual or a company that provides Biotin active pharmaceutical ingredient (API) or Biotin finished formulations upon request. The Biotin suppliers may include Biotin API manufacturers, exporters, distributors and traders.
click here to find a list of Biotin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Biotin CEP of the European Pharmacopoeia monograph is often referred to as a Biotin Certificate of Suitability (COS). The purpose of a Biotin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Biotin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Biotin to their clients by showing that a Biotin CEP has been issued for it. The manufacturer submits a Biotin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Biotin CEP holder for the record. Additionally, the data presented in the Biotin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Biotin DMF.
A Biotin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Biotin 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 Biotin suppliers with CEP (COS) on PharmaCompass.
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