01 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
02 1HETERO DRUGS LIMITED Hyderabad IN
03 1MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN
04 1ZYDUS LIFESCIENCES LIMITED Vadodara IN
01 4Topiramate
01 4India
01 4Valid
Certificate Number : CEP 2020-140 - Rev 03
Status : Valid
Issue Date : 2023-12-18
Type : Chemical
Substance Number : 2616
Certificate Number : R0-CEP 2020-130 - Rev 01
Status : Valid
Issue Date : 2023-03-06
Type : Chemical
Substance Number : 2616
Certificate Number : R0-CEP 2020-201 - Rev 01
Status : Valid
Issue Date : 2022-03-02
Type : Chemical
Substance Number : 2616
Certificate Number : CEP 2021-419 - Rev 01
Status : Valid
Issue Date : 2024-10-09
Type : Chemical
Substance Number : 2616
A Topiramate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topiramate, including repackagers and relabelers. The FDA regulates Topiramate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topiramate 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 Topiramate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topiramate supplier is an individual or a company that provides Topiramate active pharmaceutical ingredient (API) or Topiramate finished formulations upon request. The Topiramate suppliers may include Topiramate API manufacturers, exporters, distributors and traders.
click here to find a list of Topiramate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Topiramate CEP of the European Pharmacopoeia monograph is often referred to as a Topiramate Certificate of Suitability (COS). The purpose of a Topiramate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Topiramate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Topiramate to their clients by showing that a Topiramate CEP has been issued for it. The manufacturer submits a Topiramate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Topiramate CEP holder for the record. Additionally, the data presented in the Topiramate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Topiramate DMF.
A Topiramate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Topiramate 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 Topiramate suppliers with CEP (COS) on PharmaCompass.
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