ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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01 1ChemWerth Inc
02 1Apothecon Pharmaceuticals
03 1GLAND PHARMA LIMITED
04 1Hikma Pharmaceuticals
05 2Lusochimica
06 1MSN Laboratories
07 1Maprimed
08 1Mitsubishi Corporation
09 1Qilu Pharmaceutical
10 1Sichuan Qingmu Pharmaceutical
11 1Sifavitor srl
12 1Wockhardt
13 1Zhejiang Huahai Pharmaceutical
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01 7NICARDIPINE HYDROCHLORIDE
02 1NICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE)
03 5NICARDIPINE HYDROCHLORIDE USP
04 1NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE
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01 1Argentina
02 3China
03 4India
04 3Italy
05 1Japan
06 1U.S.A
07 1United Kingdom
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01 12Active
02 2Inactive
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01 8Complete
02 6Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19552
Submission : 2006-06-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-05
Pay. Date : 2020-09-29
DMF Number : 19773
Submission : 2006-09-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29198
Submission : 2015-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23280
Submission : 2009-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-20
DMF Number : 9493
Submission : 1992-01-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-09
DMF Number : 21625
Submission : 2008-03-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-08
Pay. Date : 2023-01-09
DMF Number : 37582
Submission : 2023-01-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-15
Pay. Date : 2022-08-26
DMF Number : 37287
Submission : 2022-08-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-28
Pay. Date : 2017-09-25
DMF Number : 10104
Submission : 1993-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21211
Submission : 2007-12-31
Status : Active
Type : II
A Perdipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perdipine, including repackagers and relabelers. The FDA regulates Perdipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perdipine 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 Perdipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perdipine supplier is an individual or a company that provides Perdipine active pharmaceutical ingredient (API) or Perdipine finished formulations upon request. The Perdipine suppliers may include Perdipine API manufacturers, exporters, distributors and traders.
click here to find a list of Perdipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perdipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Perdipine active pharmaceutical ingredient (API) in detail. Different forms of Perdipine DMFs exist exist since differing nations have different regulations, such as Perdipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perdipine DMF submitted to regulatory agencies in the US is known as a USDMF. Perdipine USDMF includes data on Perdipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perdipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perdipine suppliers with USDMF on PharmaCompass.
We have 13 companies offering Perdipine
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