Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN
01 1Procainamide Hydrochloride
01 1India
01 1Valid
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : CEP 2019-119 - Rev 02
Status : Valid
Issue Date : 2025-08-25
Type : Chemical
Substance Number : 567
40
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A Pronestyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pronestyl, including repackagers and relabelers. The FDA regulates Pronestyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pronestyl 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 Pronestyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pronestyl supplier is an individual or a company that provides Pronestyl active pharmaceutical ingredient (API) or Pronestyl finished formulations upon request. The Pronestyl suppliers may include Pronestyl API manufacturers, exporters, distributors and traders.
click here to find a list of Pronestyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pronestyl CEP of the European Pharmacopoeia monograph is often referred to as a Pronestyl Certificate of Suitability (COS). The purpose of a Pronestyl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pronestyl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pronestyl to their clients by showing that a Pronestyl CEP has been issued for it. The manufacturer submits a Pronestyl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pronestyl CEP holder for the record. Additionally, the data presented in the Pronestyl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pronestyl DMF.
A Pronestyl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pronestyl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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