01 13M Company
02 1Grace
03 2ORGAMOL PHARMA SOLUTIONS SA
04 2Procos
05 2R L Fine Chem
06 1Blank
01 5ORPHENADRINE CITRATE
02 1ORPHENADRINE CITRATE AND ORPHENADRINE HCL.
03 1ORPHENADRINE CITRATE USP
04 1ORPHENADRINE CITRATE/ORPHENADRINE HCL (TRANSFER TO DMF 4811 1/13/88)
05 1ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE
01 2India
02 2Italy
03 2Switzerland
04 2U.S.A
05 1Blank
01 4Active
02 5Inactive
01 2Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7108
Submission : 1987-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-16
Pay. Date : 2013-07-05
DMF Number : 5722
Submission : 1985-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4457
Submission : 1982-02-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4811
Submission : 1983-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-13
Pay. Date : 2014-10-31
DMF Number : 14971
Submission : 2000-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2942
Submission : 1977-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38456
Submission : 2023-06-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33901
Submission : 2019-05-29
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7837
Submission : 1988-12-20
Status : Inactive
Type : II
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A Orphenadrine Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orphenadrine Citrate, including repackagers and relabelers. The FDA regulates Orphenadrine Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orphenadrine Citrate 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 Orphenadrine Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Orphenadrine Citrate supplier is an individual or a company that provides Orphenadrine Citrate active pharmaceutical ingredient (API) or Orphenadrine Citrate finished formulations upon request. The Orphenadrine Citrate suppliers may include Orphenadrine Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Orphenadrine Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orphenadrine Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Orphenadrine Citrate active pharmaceutical ingredient (API) in detail. Different forms of Orphenadrine Citrate DMFs exist exist since differing nations have different regulations, such as Orphenadrine Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orphenadrine Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Orphenadrine Citrate USDMF includes data on Orphenadrine Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orphenadrine Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Orphenadrine Citrate suppliers with USDMF on PharmaCompass.
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