01 1Alembic Pharmaceuticals Limited
02 1Bayer AG
03 1Emcure Pharmaceuticals
04 1Erregierre SpA
05 1Lusochimica
06 1Orchid Pharma
07 1Par Pharmaceutical
08 1Sanmar Speciality Chemicals Limited IN 600 086 Chennai
01 5NISOLDIPINE
02 1NISOLDIPINE (NON-STERILE BULK API)
03 1NISOLDIPINE NON STERILE BULK DRUG SUBSTANCE
04 1NISOLDIPINE, NON-STERILE BULK DRUG SUBSTANCE
01 1Germany
02 4India
03 2Italy
04 1U.S.A
01 7Active
02 1Inactive
01 3Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-23
Pay. Date : 2013-09-26
DMF Number : 25365
Submission : 2011-10-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10167
Submission : 1993-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-06-07
DMF Number : 25750
Submission : 2012-03-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-10
DMF Number : 16215
Submission : 2002-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14337
Submission : 1999-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22539
Submission : 2009-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21106
Submission : 2007-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19329
Submission : 2006-04-04
Status : Inactive
Type : II
A Nisoldipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nisoldipine, including repackagers and relabelers. The FDA regulates Nisoldipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nisoldipine 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 Nisoldipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nisoldipine supplier is an individual or a company that provides Nisoldipine active pharmaceutical ingredient (API) or Nisoldipine finished formulations upon request. The Nisoldipine suppliers may include Nisoldipine API manufacturers, exporters, distributors and traders.
click here to find a list of Nisoldipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nisoldipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nisoldipine active pharmaceutical ingredient (API) in detail. Different forms of Nisoldipine DMFs exist exist since differing nations have different regulations, such as Nisoldipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nisoldipine DMF submitted to regulatory agencies in the US is known as a USDMF. Nisoldipine USDMF includes data on Nisoldipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nisoldipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nisoldipine suppliers with USDMF on PharmaCompass.
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