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 : 4811
Submission : 1983-01-21
Status : Inactive
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 : 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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
57
PharmaCompass offers a list of Orphenadrine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Orphenadrine manufacturer or Orphenadrine supplier for your needs.
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A Tega-Flex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tega-Flex, including repackagers and relabelers. The FDA regulates Tega-Flex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tega-Flex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Tega-Flex supplier is an individual or a company that provides Tega-Flex active pharmaceutical ingredient (API) or Tega-Flex finished formulations upon request. The Tega-Flex suppliers may include Tega-Flex API manufacturers, exporters, distributors and traders.
click here to find a list of Tega-Flex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tega-Flex DMF (Drug Master File) is a document detailing the whole manufacturing process of Tega-Flex active pharmaceutical ingredient (API) in detail. Different forms of Tega-Flex DMFs exist exist since differing nations have different regulations, such as Tega-Flex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tega-Flex DMF submitted to regulatory agencies in the US is known as a USDMF. Tega-Flex USDMF includes data on Tega-Flex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tega-Flex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tega-Flex suppliers with USDMF on PharmaCompass.
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