01 2CHONGQING HUAPONT PHARMACEUTICAL CO., LTD. Chongqing CN
02 1F Hoffmann-La Roche Ltd. Basel CH
03 1HAS HEALTHCARE ADVANCED SYNTHESIS SA Biasca CH
04 1HETERO DRUGS LIMITED Hyderabad IN
05 1IPCA LABORATORIES LIMITED Mumbai IN
06 1OLON S.P.A. Rodano IT
07 1SHANGHAI NEW HUALIAN PHARMACEUTICAL CO., LTD. Shanghai CN
08 1SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH Minden DE
09 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
01 9Isotretinoin
02 1Isotretinoin, Process 2
01 3China
02 3India
03 1Italy
04 2Switzerland
05 1U.S.A
01 8Valid
02 2Withdrawn by Holder
Certificate Number : R1-CEP 2009-330 - Rev 00
Status : Valid
Issue Date : 2016-10-13
Type : Chemical
Substance Number : 1019
Certificate Number : CEP 2018-219 - Rev 01
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 1019
Certificate Number : R1-CEP 2002-034 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2008-11-25
Type : Chemical
Substance Number : 1019
Certificate Number : R1-CEP 2004-281 - Rev 01
Status : Valid
Issue Date : 2022-03-01
Type : Chemical
Substance Number : 1019
Certificate Number : CEP 2022-205 - Rev 01
Status : Valid
Issue Date : 2024-07-31
Type : Chemical
Substance Number : 1019
Certificate Number : R0-CEP 2009-203 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2010-11-26
Type : Chemical
Substance Number : 1019
Certificate Number : R1-CEP 1996-082 - Rev 12
Status : Valid
Issue Date : 2022-04-12
Type : Chemical
Substance Number : 1019
Certificate Number : R1-CEP 2008-231 - Rev 02
Status : Valid
Issue Date : 2020-06-22
Type : Chemical
Substance Number : 1019
Certificate Number : R1-CEP 1999-068 - Rev 07
Status : Valid
Issue Date : 2023-03-10
Type : Chemical
Substance Number : 1019
Certificate Number : R1-CEP 2002-011 - Rev 06
Status : Valid
Issue Date : 2023-05-25
Type : Chemical
Substance Number : 1019
A Isotretinoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isotretinoin, including repackagers and relabelers. The FDA regulates Isotretinoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isotretinoin 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 Isotretinoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isotretinoin supplier is an individual or a company that provides Isotretinoin active pharmaceutical ingredient (API) or Isotretinoin finished formulations upon request. The Isotretinoin suppliers may include Isotretinoin API manufacturers, exporters, distributors and traders.
click here to find a list of Isotretinoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isotretinoin CEP of the European Pharmacopoeia monograph is often referred to as a Isotretinoin Certificate of Suitability (COS). The purpose of a Isotretinoin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isotretinoin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isotretinoin to their clients by showing that a Isotretinoin CEP has been issued for it. The manufacturer submits a Isotretinoin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isotretinoin CEP holder for the record. Additionally, the data presented in the Isotretinoin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isotretinoin DMF.
A Isotretinoin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isotretinoin 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 Isotretinoin suppliers with CEP (COS) on PharmaCompass.
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