Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1Alembic Pharmaceuticals Limited
03 1Aurobindo Pharma Limited
04 1Changzhou Ruiming Pharmaceutical
05 1Cipla
06 1Emcure Pharmaceuticals
07 1Esteve Quimica
08 1Everlight Chemical
09 1HEC Pharm
10 1Hainan Poly Pharm
11 1Korea United Pharm. Inc.
12 1Orchid Pharma
13 1Wockhardt
14 1Yangzhou Pharmaceutical
15 1Yangzhou Pharmaceutical Factory
16 1Zhejiang Supor Pharmaceuticals Co., LTD
01 7FELODIPINE
02 1FELODIPINE (NON-STERILE BULK API)
03 1FELODIPINE EXTENDED RELEASE TABLETS
04 1FELODIPINE NON-STERILE BULK DRUG SUBSTANCE
05 3FELODIPINE USP
06 1FELODIPINE USP, NON-STERILE DRUG SUBSTANCE
07 1FELODIPINE, NON-STERILE DRUG SUBSTANCE USP
08 1Felodipine USP
01 6China
02 6India
03 1South Korea
04 2Spain
05 1Taiwan
01 7Active
02 9Inactive
01 4Complete
02 12Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-28
Pay. Date : 2013-03-14
DMF Number : 14099
Submission : 1999-05-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-03
Pay. Date : 2013-09-27
DMF Number : 25373
Submission : 2011-10-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20890
Submission : 2007-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11449
Submission : 1995-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12248
Submission : 1996-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-05
Pay. Date : 2015-09-24
DMF Number : 17030
Submission : 2003-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21354
Submission : 2008-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13255
Submission : 1998-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14786
Submission : 2000-03-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-09-03
DMF Number : 19449
Submission : 2006-05-16
Status : Active
Type : II
A Felodipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Felodipine, including repackagers and relabelers. The FDA regulates Felodipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Felodipine 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 Felodipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Felodipine supplier is an individual or a company that provides Felodipine active pharmaceutical ingredient (API) or Felodipine finished formulations upon request. The Felodipine suppliers may include Felodipine API manufacturers, exporters, distributors and traders.
click here to find a list of Felodipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Felodipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Felodipine active pharmaceutical ingredient (API) in detail. Different forms of Felodipine DMFs exist exist since differing nations have different regulations, such as Felodipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Felodipine DMF submitted to regulatory agencies in the US is known as a USDMF. Felodipine USDMF includes data on Felodipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Felodipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Felodipine suppliers with USDMF on PharmaCompass.
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