01 1HETERO LABS LIMITED Hyderabad IN
01 1Stavudine
01 1India
01 1Withdrawn by Holder
Certificate Number : R1-CEP 2008-162 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2017-08-10
Type : Chemical
Substance Number : 2130
A Stavudine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stavudine, including repackagers and relabelers. The FDA regulates Stavudine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stavudine 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 Stavudine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Stavudine supplier is an individual or a company that provides Stavudine active pharmaceutical ingredient (API) or Stavudine finished formulations upon request. The Stavudine suppliers may include Stavudine API manufacturers, exporters, distributors and traders.
click here to find a list of Stavudine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Stavudine CEP of the European Pharmacopoeia monograph is often referred to as a Stavudine Certificate of Suitability (COS). The purpose of a Stavudine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Stavudine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Stavudine to their clients by showing that a Stavudine CEP has been issued for it. The manufacturer submits a Stavudine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Stavudine CEP holder for the record. Additionally, the data presented in the Stavudine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Stavudine DMF.
A Stavudine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Stavudine 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 Stavudine suppliers with CEP (COS) on PharmaCompass.
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