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 Kinfil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kinfil, including repackagers and relabelers. The FDA regulates Kinfil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kinfil 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 Kinfil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Kinfil supplier is an individual or a company that provides Kinfil active pharmaceutical ingredient (API) or Kinfil finished formulations upon request. The Kinfil suppliers may include Kinfil API manufacturers, exporters, distributors and traders.
click here to find a list of Kinfil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Kinfil DMF (Drug Master File) is a document detailing the whole manufacturing process of Kinfil active pharmaceutical ingredient (API) in detail. Different forms of Kinfil DMFs exist exist since differing nations have different regulations, such as Kinfil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Kinfil DMF submitted to regulatory agencies in the US is known as a USDMF. Kinfil USDMF includes data on Kinfil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Kinfil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Kinfil suppliers with USDMF on PharmaCompass.
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