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01 1Natco Pharma
02 1ORGANICA Feinchemie GmbH Wolfen
03 1Olon S.p.A
04 1Trifarma
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01 1BENZHEXOL HCL. (TRIHEXYPHENIDYL HCL.)
02 1TRIHEXIPHENIDYL HYDROCHLORIDE
03 1TRIHEXYPHENIDYL HCL
04 1TRIHEXYPHENIDYL HYDROCHLORIDE
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01 1Germany
02 1India
03 2Italy
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01 2Active
02 2Inactive
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01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22576
Submission : 2009-02-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2693
Submission : 1976-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2785
Submission : 1976-11-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5802
Submission : 1985-02-27
Status : Inactive
Type : II
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A Apotex Brand of Trihexyphenidyl Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apotex Brand of Trihexyphenidyl Hydrochloride, including repackagers and relabelers. The FDA regulates Apotex Brand of Trihexyphenidyl Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apotex Brand of Trihexyphenidyl Hydrochloride 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 Apotex Brand of Trihexyphenidyl Hydrochloride supplier is an individual or a company that provides Apotex Brand of Trihexyphenidyl Hydrochloride active pharmaceutical ingredient (API) or Apotex Brand of Trihexyphenidyl Hydrochloride finished formulations upon request. The Apotex Brand of Trihexyphenidyl Hydrochloride suppliers may include Apotex Brand of Trihexyphenidyl Hydrochloride API manufacturers, exporters, distributors and traders.
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A Apotex Brand of Trihexyphenidyl Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Apotex Brand of Trihexyphenidyl Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Apotex Brand of Trihexyphenidyl Hydrochloride DMFs exist exist since differing nations have different regulations, such as Apotex Brand of Trihexyphenidyl Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apotex Brand of Trihexyphenidyl Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Apotex Brand of Trihexyphenidyl Hydrochloride USDMF includes data on Apotex Brand of Trihexyphenidyl Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apotex Brand of Trihexyphenidyl Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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