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Status : Withdrawn by Holder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Status : Withdrawn by Holder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
17
PharmaCompass offers a list of Isotretinoin 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 Isotretinoin manufacturer or Isotretinoin supplier for your needs.
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PharmaCompass also assists you with knowing the Isotretinoin API Price utilized in the formulation of products. Isotretinoin API Price is not always fixed or binding as the Isotretinoin Price is obtained through a variety of data sources. The Isotretinoin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Roaccutane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roaccutane, including repackagers and relabelers. The FDA regulates Roaccutane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roaccutane 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 Roaccutane supplier is an individual or a company that provides Roaccutane active pharmaceutical ingredient (API) or Roaccutane finished formulations upon request. The Roaccutane suppliers may include Roaccutane API manufacturers, exporters, distributors and traders.
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A Roaccutane CEP of the European Pharmacopoeia monograph is often referred to as a Roaccutane Certificate of Suitability (COS). The purpose of a Roaccutane CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Roaccutane EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Roaccutane to their clients by showing that a Roaccutane CEP has been issued for it. The manufacturer submits a Roaccutane CEP (COS) as part of the market authorization procedure, and it takes on the role of a Roaccutane CEP holder for the record. Additionally, the data presented in the Roaccutane CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Roaccutane DMF.
A Roaccutane CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Roaccutane 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 Roaccutane suppliers with CEP (COS) on PharmaCompass.
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