Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 2Neuland Laboratories
03 1Farmhispania
04 1Apotex Pharmachem
05 1ChemSource
06 1Esteve Quimica
07 1Gedeon Richter
08 2Krka
09 1Lek Pharmaceuticals
10 2Maprimed
11 1Merck & Co
12 1RANBAXY LABORATORIES LIMITED
13 1Wockhardt
14 1Zhejiang Huahai Pharmaceutical
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13055
Submission : 1998-06-29
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15434
Submission : 2001-05-15
Status :
Type : II
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11525
Submission : 1995-05-19
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-28
Pay. Date : 2016-06-16
DMF Number : 19984
Submission : 2006-11-17
Status :
Type : II
A Enalapril Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enalapril Maleate, including repackagers and relabelers. The FDA regulates Enalapril Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enalapril Maleate 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 Enalapril Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enalapril Maleate supplier is an individual or a company that provides Enalapril Maleate active pharmaceutical ingredient (API) or Enalapril Maleate finished formulations upon request. The Enalapril Maleate suppliers may include Enalapril Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Enalapril Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Enalapril Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Enalapril Maleate active pharmaceutical ingredient (API) in detail. Different forms of Enalapril Maleate DMFs exist exist since differing nations have different regulations, such as Enalapril Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enalapril Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Enalapril Maleate USDMF includes data on Enalapril Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enalapril Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Enalapril Maleate suppliers with USDMF on PharmaCompass.
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