01 1EMNAR PHARMA PRIVATE LIMITED Hyderabad IN
01 1Potassium hydrogen carbonate
01 1India
01 1Valid
Certificate Number : CEP 2025-387 - Rev 00
Status : Valid
Issue Date : 2025-12-01
Type : Chemical
Substance Number : 1141
93
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A LS-2382 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LS-2382, including repackagers and relabelers. The FDA regulates LS-2382 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LS-2382 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 LS-2382 supplier is an individual or a company that provides LS-2382 active pharmaceutical ingredient (API) or LS-2382 finished formulations upon request. The LS-2382 suppliers may include LS-2382 API manufacturers, exporters, distributors and traders.
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A LS-2382 CEP of the European Pharmacopoeia monograph is often referred to as a LS-2382 Certificate of Suitability (COS). The purpose of a LS-2382 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LS-2382 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LS-2382 to their clients by showing that a LS-2382 CEP has been issued for it. The manufacturer submits a LS-2382 CEP (COS) as part of the market authorization procedure, and it takes on the role of a LS-2382 CEP holder for the record. Additionally, the data presented in the LS-2382 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LS-2382 DMF.
A LS-2382 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LS-2382 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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