01 1AUROBINDO PHARMA LIMITED Hyderabad IN
02 1MYLAN LABORATORIES LIMITED Hyderabad IN
01 2Didanosine
01 1India
02 1U.S.A
01 1Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 2007-301 - Rev 02
Status : Valid
Issue Date : 2017-02-03
Type : Chemical
Substance Number : 2200
Certificate Number : R0-CEP 2013-356 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2017-09-18
Type : Chemical
Substance Number : 2200
A Didanosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Didanosine, including repackagers and relabelers. The FDA regulates Didanosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Didanosine 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 Didanosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Didanosine supplier is an individual or a company that provides Didanosine active pharmaceutical ingredient (API) or Didanosine finished formulations upon request. The Didanosine suppliers may include Didanosine API manufacturers, exporters, distributors and traders.
click here to find a list of Didanosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Didanosine CEP of the European Pharmacopoeia monograph is often referred to as a Didanosine Certificate of Suitability (COS). The purpose of a Didanosine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Didanosine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Didanosine to their clients by showing that a Didanosine CEP has been issued for it. The manufacturer submits a Didanosine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Didanosine CEP holder for the record. Additionally, the data presented in the Didanosine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Didanosine DMF.
A Didanosine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Didanosine 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 Didanosine suppliers with CEP (COS) on PharmaCompass.
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