01 1Apicore LLC
02 1Catalent Pharma Solutions
03 1Emcure Pharmaceuticals
04 1Hetero Drugs
05 1MSN Laboratories
06 1Refarmed Chemicals
07 1Tianjin Weijie Pharmaceutical Co., Ltd.
01 5BEXAROTENE
02 1BEXAROTENE [ROUTE CODE BX]
03 1TARGRETIN 75 MG SOFT-GELATIN CAPSULE
01 1China
02 4India
03 1Switzerland
04 1U.S.A
01 6Active
02 1Inactive
01 5Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-07
Pay. Date : 2015-07-29
DMF Number : 23631
Submission : 2010-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14086
Submission : 1999-04-19
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-27
Pay. Date : 2020-09-18
DMF Number : 31979
Submission : 2017-10-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-02
Pay. Date : 2015-06-05
DMF Number : 28944
Submission : 2014-12-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2016-03-29
DMF Number : 30077
Submission : 2016-01-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-17
Pay. Date : 2016-02-19
DMF Number : 25542
Submission : 2011-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31580
Submission : 2017-04-05
Status : Active
Type : II
A Bexarotene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bexarotene, including repackagers and relabelers. The FDA regulates Bexarotene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bexarotene 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 Bexarotene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bexarotene supplier is an individual or a company that provides Bexarotene active pharmaceutical ingredient (API) or Bexarotene finished formulations upon request. The Bexarotene suppliers may include Bexarotene API manufacturers, exporters, distributors and traders.
click here to find a list of Bexarotene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bexarotene DMF (Drug Master File) is a document detailing the whole manufacturing process of Bexarotene active pharmaceutical ingredient (API) in detail. Different forms of Bexarotene DMFs exist exist since differing nations have different regulations, such as Bexarotene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bexarotene DMF submitted to regulatory agencies in the US is known as a USDMF. Bexarotene USDMF includes data on Bexarotene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bexarotene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bexarotene suppliers with USDMF on PharmaCompass.
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