01 1Cyclo Industries
02 1F. Hoffmann-La Roche
03 1Royal DSM
04 2SIGMA TAU
05 1Blank
01 4BIOTIN
02 1N-HYDROXYSUCCINIMIDOBIOTIN - PRODUCT NO. H 1759 FD
03 1d-BIOTIN
01 1Netherlands
02 1Switzerland
03 3U.S.A
04 1Blank
01 2Active
02 4Inactive
01 1Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8820
Submission : 1990-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3054
Submission : 1977-11-17
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2017-01-10
DMF Number : 30157
Submission : 2016-01-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9706
Submission : 1992-05-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4529
Submission : 1982-05-05
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39548
Submission : 2024-02-18
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Biotin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biotin, including repackagers and relabelers. The FDA regulates Biotin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biotin 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 Biotin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biotin supplier is an individual or a company that provides Biotin active pharmaceutical ingredient (API) or Biotin finished formulations upon request. The Biotin suppliers may include Biotin API manufacturers, exporters, distributors and traders.
click here to find a list of Biotin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Biotin DMF (Drug Master File) is a document detailing the whole manufacturing process of Biotin active pharmaceutical ingredient (API) in detail. Different forms of Biotin DMFs exist exist since differing nations have different regulations, such as Biotin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Biotin DMF submitted to regulatory agencies in the US is known as a USDMF. Biotin USDMF includes data on Biotin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biotin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Biotin suppliers with USDMF on PharmaCompass.
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