01 1ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN
02 1CIPLA LIMITED Mumbai IN
03 1EMCURE PHARMACEUTICALS LIMITED Pune IN
04 1FORMOSA LABORATORIES, INC. Taoyuan TW
05 1MAPRIMED S.A. Buenos Aires AR
01 5Leflunomide
01 1Argentina
02 3India
03 1Taiwan
01 5Valid
Certificate Number : R1-CEP 2007-172 - Rev 02
Status : Valid
Issue Date : 2018-09-04
Type : Chemical
Substance Number : 2330
Certificate Number : R1-CEP 2007-050 - Rev 01
Status : Valid
Issue Date : 2014-07-28
Type : Chemical
Substance Number : 2330
Certificate Number : CEP 2018-269 - Rev 02
Status : Valid
Issue Date : 2024-09-11
Type : Chemical
Substance Number : 2330
Certificate Number : R1-CEP 2009-035 - Rev 01
Status : Valid
Issue Date : 2018-02-09
Type : Chemical
Substance Number : 2330
Certificate Number : R0-CEP 2018-252 - Rev 01
Status : Valid
Issue Date : 2022-10-27
Type : Chemical
Substance Number : 2330
A Leflunomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leflunomide, including repackagers and relabelers. The FDA regulates Leflunomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leflunomide 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 Leflunomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leflunomide supplier is an individual or a company that provides Leflunomide active pharmaceutical ingredient (API) or Leflunomide finished formulations upon request. The Leflunomide suppliers may include Leflunomide API manufacturers, exporters, distributors and traders.
click here to find a list of Leflunomide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Leflunomide CEP of the European Pharmacopoeia monograph is often referred to as a Leflunomide Certificate of Suitability (COS). The purpose of a Leflunomide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Leflunomide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Leflunomide to their clients by showing that a Leflunomide CEP has been issued for it. The manufacturer submits a Leflunomide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Leflunomide CEP holder for the record. Additionally, the data presented in the Leflunomide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Leflunomide DMF.
A Leflunomide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Leflunomide 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 Leflunomide suppliers with CEP (COS) on PharmaCompass.
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