Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik
02 1TAPI Technology & API Services
03 3AstraZeneca
04 1Aurobindo Pharma Limited
05 1Emcure Pharmaceuticals
06 1Esteve Quimica
07 1Gedeon Richter
08 2Hetero Drugs
09 1Ipca Laboratories
10 1Lek Pharmaceuticals
11 1Lupin Ltd
12 1RANBAXY LABORATORIES LIMITED
13 1Unimark Remedies Limited
14 1Viatris
15 1Zhejiang Changming Pharmaceuticals
16 1Zhejiang Huahai Pharmaceutical
01 4LISINOPRIL
02 1LISINOPRIL ACTIVE DRUG SUBSTANCE
03 1LISINOPRIL BULK DRUG
04 2LISINOPRIL DIHYDRATE
05 1LISINOPRIL DIHYDRATE USP (NON-STERILE)
06 1LISINOPRIL DIHYDRATE, USP
07 1LISINOPRIL DRUG SUBSTANCE
08 1LISINOPRIL PROCESS-III
09 5LISINOPRIL USP
10 1LISINOPRIL USP (NON-STERILE BULK)
11 1ZESTRIL (LISINOPRIL) TABLETS
01 2China
02 1Germany
03 1Hungary
04 8India
05 1Israel
06 1Slovenia
07 1Spain
08 1U.S.A
09 3United Kingdom
01 8Active
02 11Inactive
01 6Complete
02 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19138
Submission : 2006-01-26
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14774
Submission : 2000-03-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6911
Submission : 1987-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-15
Pay. Date : 2021-04-28
DMF Number : 35620
Submission : 2021-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-08
Pay. Date : 2023-03-16
DMF Number : 38132
Submission : 2023-03-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-11
Pay. Date : 2012-11-29
DMF Number : 16510
Submission : 2003-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15098
Submission : 2000-10-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-03-13
DMF Number : 17626
Submission : 2004-08-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2013-09-27
DMF Number : 27385
Submission : 2013-09-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-28
Pay. Date : 2013-03-19
DMF Number : 14801
Submission : 2000-03-24
Status : Active
Type : II
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 DMF (Drug Master File) is a document detailing the whole manufacturing process of ZESTRIL active pharmaceutical ingredient (API) in detail. Different forms of ZESTRIL DMFs exist exist since differing nations have different regulations, such as ZESTRIL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ZESTRIL DMF submitted to regulatory agencies in the US is known as a USDMF. ZESTRIL USDMF includes data on ZESTRIL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ZESTRIL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ZESTRIL suppliers with USDMF on PharmaCompass.
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