01 1FLEMING LABORATORIES LIMITED Hyderabad IN
02 1MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN
01 2Penicillamine
01 2India
01 2Valid
Certificate Number : CEP 2022-136 - Rev 00
Status : Valid
Issue Date : 2024-06-17
Type : Chemical
Substance Number : 566
Certificate Number : R0-CEP 2020-240 - Rev 00
Status : Valid
Issue Date : 2022-11-14
Type : Chemical
Substance Number : 566
A Penicillamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penicillamine, including repackagers and relabelers. The FDA regulates Penicillamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penicillamine 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 Penicillamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Penicillamine supplier is an individual or a company that provides Penicillamine active pharmaceutical ingredient (API) or Penicillamine finished formulations upon request. The Penicillamine suppliers may include Penicillamine API manufacturers, exporters, distributors and traders.
click here to find a list of Penicillamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Penicillamine CEP of the European Pharmacopoeia monograph is often referred to as a Penicillamine Certificate of Suitability (COS). The purpose of a Penicillamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Penicillamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Penicillamine to their clients by showing that a Penicillamine CEP has been issued for it. The manufacturer submits a Penicillamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Penicillamine CEP holder for the record. Additionally, the data presented in the Penicillamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Penicillamine DMF.
A Penicillamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Penicillamine 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 Penicillamine suppliers with CEP (COS) on PharmaCompass.
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