Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1EVONIK OPERATIONS GMBH Essen DE
02 1AUROBINDO PHARMA LIMITED Hyderabad IN
03 1ESTEVE QUIMICA S.A. Barcelona ES
04 1Farmhispania, S.A. Montmeló ES
05 1GEDEON RICHTER PLC Budapest HU
06 3HETERO DRUGS LIMITED Hyderabad IN
07 1LEK PHARMACEUTICALS D.D. Ljubljana SI
08 1LUPIN LIMITED Mumbai IN
09 1MYLAN LABORATORIES LIMITED Hyderabad IN
10 1RICHTER THEMIS MEDICARE (I) PVT. LTD. Vapi IN
11 1Ranbaxy Laboratories Limited Gurgaon IN
12 1UNIMARK REMEDIES LIMITED Mumbai IN
13 1ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Tiantai CN
14 2ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN
01 14Lisinopril dihydrate
02 1Lisinopril dihydrate, Anhydride Process
03 1Lisinopril dihydrate, Process II
04 1Lisinopril dihydrate, Process-III
01 3China
02 1Germany
03 1Hungary
04 8India
05 1Slovenia
06 2Spain
07 1U.S.A
01 1Suspended by Holder
02 9Valid
03 7Withdrawn by Holder
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Certificate Number : R1-CEP 2004-011 - Rev 07
Status : Valid
Issue Date : 2020-12-09
Type : Chemical
Substance Number : 1120
Lisinopril Dihydrate, Process II
Certificate Number : CEP 2016-197 - Rev 02
Status : Valid
Issue Date : 2024-07-03
Type : Chemical
Substance Number : 1120
Lisinopril Dihydrate, Process-III
Certificate Number : CEP 2022-434 - Rev 02
Status : Valid
Issue Date : 2024-07-03
Type : Chemical
Substance Number : 1120
Certificate Number : R0-CEP 2006-065 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2008-08-12
Type : Chemical
Substance Number : 1120
Certificate Number : R1-CEP 2001-311 - Rev 04
Status : Valid
Issue Date : 2019-09-27
Type : Chemical
Substance Number : 1120
Certificate Number : R0-CEP 2018-223 - Rev 00
Status : Valid
Issue Date : 2020-05-14
Type : Chemical
Substance Number : 1120
Certificate Number : R1-CEP 2005-249 - Rev 02
Status : Valid
Issue Date : 2015-04-02
Type : Chemical
Substance Number : 1120
Certificate Number : R1-CEP 2011-002 - Rev 00
Status : Valid
Issue Date : 2017-01-23
Type : Chemical
Substance Number : 1120
Certificate Number : CEP 2003-064 - Rev 06
Status : Valid
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 1120
Lisinopril Dihydrate, Anhydride Process
Certificate Number : CEP 2022-237 - Rev 02
Status : Valid
Issue Date : 2024-07-24
Type : Chemical
Substance Number : 1120
A ZESTRIL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ZESTRIL, including repackagers and relabelers. The FDA regulates ZESTRIL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ZESTRIL 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 ZESTRIL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ZESTRIL supplier is an individual or a company that provides ZESTRIL active pharmaceutical ingredient (API) or ZESTRIL finished formulations upon request. The ZESTRIL suppliers may include ZESTRIL API manufacturers, exporters, distributors and traders.
click here to find a list of ZESTRIL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ZESTRIL CEP of the European Pharmacopoeia monograph is often referred to as a ZESTRIL Certificate of Suitability (COS). The purpose of a ZESTRIL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ZESTRIL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ZESTRIL to their clients by showing that a ZESTRIL CEP has been issued for it. The manufacturer submits a ZESTRIL CEP (COS) as part of the market authorization procedure, and it takes on the role of a ZESTRIL CEP holder for the record. Additionally, the data presented in the ZESTRIL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ZESTRIL DMF.
A ZESTRIL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ZESTRIL 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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