Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1Cilag AG
03 1Derivados Quimicos SAU
04 1Dipharma
05 1Fleming Laboratories
06 1Hetero Drugs
07 1Heumann
08 1Jubilant Generics
09 1Macleods Pharmaceuticals Limited
10 1R L Fine Chem
11 1Sandoz B2B
12 1Sifavitor srl
13 1Unichem Laboratories Limited
14 1Vasudha Pharma Chem
15 2Blank
01 3CYCLOBENZAPRINE HCL
02 1CYCLOBENZAPRINE HCL USP
03 7CYCLOBENZAPRINE HYDROCHLORIDE
04 1CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED RELEASE PELLETS
05 1CYCLOBENZAPRINE HYDROCHLORIDE USP
06 1CYCLOBENZAPRINE HYDROCHLORIDE USP BULK
07 1CYCLOBENZAPRINE-HCL
08 1CYCLOSPORIN D
01 1Germany
02 7India
03 2Italy
04 2Spain
05 2Switzerland
06 2Blank
01 9Active
02 7Inactive
01 5Complete
02 11Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-23
Pay. Date : 2015-05-04
DMF Number : 5827
Submission : 1985-05-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23521
Submission : 2010-02-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-23
Pay. Date : 2015-06-17
DMF Number : 5864
Submission : 1985-06-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-20
Pay. Date : 2014-02-13
DMF Number : 21392
Submission : 2008-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24719
Submission : 2011-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29955
Submission : 2015-11-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-08
Pay. Date : 2020-03-04
DMF Number : 33147
Submission : 2018-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34654
Submission : 2020-03-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-27
Pay. Date : 2013-12-24
DMF Number : 21779
Submission : 2008-07-08
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5810
Submission : 1985-05-07
Status : Inactive
Type : II
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A Cyclobenzaprine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyclobenzaprine, including repackagers and relabelers. The FDA regulates Cyclobenzaprine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyclobenzaprine 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 Cyclobenzaprine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyclobenzaprine supplier is an individual or a company that provides Cyclobenzaprine active pharmaceutical ingredient (API) or Cyclobenzaprine finished formulations upon request. The Cyclobenzaprine suppliers may include Cyclobenzaprine API manufacturers, exporters, distributors and traders.
click here to find a list of Cyclobenzaprine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cyclobenzaprine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cyclobenzaprine active pharmaceutical ingredient (API) in detail. Different forms of Cyclobenzaprine DMFs exist exist since differing nations have different regulations, such as Cyclobenzaprine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cyclobenzaprine DMF submitted to regulatory agencies in the US is known as a USDMF. Cyclobenzaprine USDMF includes data on Cyclobenzaprine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cyclobenzaprine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cyclobenzaprine suppliers with USDMF on PharmaCompass.
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