01 1R L FINE CHEM PVT. LTD. Bengaluru IN
01 1Orphenadrine citrate
01 1India
01 1Valid
Certificate Number : CEP 2022-094 - Rev 00
Status : Valid
Issue Date : 2024-05-21
Type : Chemical
Substance Number : 1759
A Orphenadrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orphenadrine, including repackagers and relabelers. The FDA regulates Orphenadrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orphenadrine 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 Orphenadrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Orphenadrine supplier is an individual or a company that provides Orphenadrine active pharmaceutical ingredient (API) or Orphenadrine finished formulations upon request. The Orphenadrine suppliers may include Orphenadrine API manufacturers, exporters, distributors and traders.
click here to find a list of Orphenadrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orphenadrine CEP of the European Pharmacopoeia monograph is often referred to as a Orphenadrine Certificate of Suitability (COS). The purpose of a Orphenadrine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orphenadrine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orphenadrine to their clients by showing that a Orphenadrine CEP has been issued for it. The manufacturer submits a Orphenadrine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orphenadrine CEP holder for the record. Additionally, the data presented in the Orphenadrine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orphenadrine DMF.
A Orphenadrine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orphenadrine 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 Orphenadrine suppliers with CEP (COS) on PharmaCompass.
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