01 1Unichem Laboratories Limited Mumbai IN
01 1Amlodipine besilate, ADP process
01 1India
01 1Valid
Amlodipine Besilate, ADP Process
Certificate Number : CEP 2024-371 - Rev 00
Status : Valid
Issue Date : 2025-05-28
Type : Chemical
Substance Number : 1491
61
PharmaCompass offers a list of Amlodipine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Amlodipine manufacturer or Amlodipine supplier for your needs.
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PharmaCompass also assists you with knowing the Amlodipine API Price utilized in the formulation of products. Amlodipine API Price is not always fixed or binding as the Amlodipine Price is obtained through a variety of data sources. The Amlodipine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Amlodipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlodipine, including repackagers and relabelers. The FDA regulates Amlodipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlodipine 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 Amlodipine supplier is an individual or a company that provides Amlodipine active pharmaceutical ingredient (API) or Amlodipine finished formulations upon request. The Amlodipine suppliers may include Amlodipine API manufacturers, exporters, distributors and traders.
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A Amlodipine CEP of the European Pharmacopoeia monograph is often referred to as a Amlodipine Certificate of Suitability (COS). The purpose of a Amlodipine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amlodipine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amlodipine to their clients by showing that a Amlodipine CEP has been issued for it. The manufacturer submits a Amlodipine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amlodipine CEP holder for the record. Additionally, the data presented in the Amlodipine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amlodipine DMF.
A Amlodipine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amlodipine 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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