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
57
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A Disipal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Disipal, including repackagers and relabelers. The FDA regulates Disipal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Disipal API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Disipal supplier is an individual or a company that provides Disipal active pharmaceutical ingredient (API) or Disipal finished formulations upon request. The Disipal suppliers may include Disipal API manufacturers, exporters, distributors and traders.
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A Disipal CEP of the European Pharmacopoeia monograph is often referred to as a Disipal Certificate of Suitability (COS). The purpose of a Disipal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Disipal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Disipal to their clients by showing that a Disipal CEP has been issued for it. The manufacturer submits a Disipal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Disipal CEP holder for the record. Additionally, the data presented in the Disipal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Disipal DMF.
A Disipal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Disipal 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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