01 1DMFs Not Supported
02 1HONOUR LAB LTD
03 1International Flavors and Fragrances
04 1Royal DSM
05 1SIGMA TAU
06 2Takeda Pharmaceutical
07 1Zhejiang Tianxin Pharmaceutical Co., Ltd
01 1PYRIDOXAL HYDROCHLORIDE
02 6PYRIDOXINE HYDROCHLORIDE
03 1VITAMINS B-6, B-12--INTRINSIC FACTOR CONCENTRATE TABLETS
01 1China
02 1India
03 2Japan
04 1Netherlands
05 2U.S.A
06 1Blank
01 3Active
02 5Inactive
01 3Complete
02 5Blank
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 777
Submission : 1964-01-21
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-23
Pay. Date : 2022-12-28
DMF Number : 37706
Submission : 2023-01-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4388
Submission : 1981-11-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-09
Pay. Date : 2022-03-11
DMF Number : 36386
Submission : 2021-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3342
Submission : 1978-09-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7984
Submission : 1989-03-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4506
Submission : 1982-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2012-11-20
DMF Number : 26544
Submission : 2012-10-30
Status : Active
Type : II
A Bendectin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bendectin, including repackagers and relabelers. The FDA regulates Bendectin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bendectin 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 Bendectin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bendectin supplier is an individual or a company that provides Bendectin active pharmaceutical ingredient (API) or Bendectin finished formulations upon request. The Bendectin suppliers may include Bendectin API manufacturers, exporters, distributors and traders.
click here to find a list of Bendectin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bendectin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bendectin active pharmaceutical ingredient (API) in detail. Different forms of Bendectin DMFs exist exist since differing nations have different regulations, such as Bendectin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bendectin DMF submitted to regulatory agencies in the US is known as a USDMF. Bendectin USDMF includes data on Bendectin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bendectin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bendectin suppliers with USDMF on PharmaCompass.
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