01 1XINJIANG NUZILINE BIO-PHARMACEUTICAL CO., LTD. Tuergen CN
01 1Estrogens, conjugated, 3.00% in lactose monohydrate
01 1China
01 1Valid
Estrogens, Conjugated, 3.00% In Lactose Monohydr...
Certificate Number : R1-CEP 2010-153 - Rev 00
Status : Valid
Issue Date : 2018-02-19
Type : Chemical
Substance Number : 1512
A Premarin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Premarin, including repackagers and relabelers. The FDA regulates Premarin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Premarin 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 Premarin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Premarin supplier is an individual or a company that provides Premarin active pharmaceutical ingredient (API) or Premarin finished formulations upon request. The Premarin suppliers may include Premarin API manufacturers, exporters, distributors and traders.
click here to find a list of Premarin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Premarin CEP of the European Pharmacopoeia monograph is often referred to as a Premarin Certificate of Suitability (COS). The purpose of a Premarin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Premarin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Premarin to their clients by showing that a Premarin CEP has been issued for it. The manufacturer submits a Premarin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Premarin CEP holder for the record. Additionally, the data presented in the Premarin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Premarin DMF.
A Premarin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Premarin 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 Premarin suppliers with CEP (COS) on PharmaCompass.
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