01 1MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN
02 1MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN
01 1Dabigatran etexilate mesilate, Crystalline Form-I, Micronised and Non-micronised
02 1Dabigatran etexilate mesilate, Crystalline Form-I, micronised and non-micronised
01 2India
01 2Valid
Dabigatran Etexilate Mesilate, Crystalline Form-...
Certificate Number : CEP 2024-026 - Rev 00
Status : Valid
Issue Date : 2024-12-20
Type : Chemical
Substance Number : 3095
Dabigatran Etexilate Mesilate, Crystalline Form-...
Certificate Number : CEP 2024-012 - Rev 00
Status : Valid
Issue Date : 2024-10-09
Type : Chemical
Substance Number : 3095
A Dabigatran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabigatran, including repackagers and relabelers. The FDA regulates Dabigatran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabigatran 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 Dabigatran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dabigatran supplier is an individual or a company that provides Dabigatran active pharmaceutical ingredient (API) or Dabigatran finished formulations upon request. The Dabigatran suppliers may include Dabigatran API manufacturers, exporters, distributors and traders.
click here to find a list of Dabigatran suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dabigatran CEP of the European Pharmacopoeia monograph is often referred to as a Dabigatran Certificate of Suitability (COS). The purpose of a Dabigatran CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dabigatran EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dabigatran to their clients by showing that a Dabigatran CEP has been issued for it. The manufacturer submits a Dabigatran CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dabigatran CEP holder for the record. Additionally, the data presented in the Dabigatran CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dabigatran DMF.
A Dabigatran CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dabigatran 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 Dabigatran suppliers with CEP (COS) on PharmaCompass.
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