Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 2Bal Pharma
02 1Icrom
03 1MSN Laboratories
04 1UBE Industries
01 4BEPOTASTINE BESILATE
02 1BEPOTASTINE BESILATE [ROUTE CODE - "BB"]
01 3India
02 1Italy
03 1Japan
01 5Active
01 4Complete
02 1Blank
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-08-16
DMF Number : 27350
Submission : 2013-08-14
Status : Active
Type : II
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-09-10
DMF Number : 27386
Submission : 2013-08-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-08-30
DMF Number : 27465
Submission : 2013-08-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-05
Pay. Date : 2019-01-29
DMF Number : 28012
Submission : 2014-03-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19966
Submission : 2006-11-15
Status : Active
Type : II
A Bepotastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bepotastine, including repackagers and relabelers. The FDA regulates Bepotastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bepotastine 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 Bepotastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bepotastine supplier is an individual or a company that provides Bepotastine active pharmaceutical ingredient (API) or Bepotastine finished formulations upon request. The Bepotastine suppliers may include Bepotastine API manufacturers, exporters, distributors and traders.
click here to find a list of Bepotastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bepotastine DMF (Drug Master File) is a document detailing the whole manufacturing process of Bepotastine active pharmaceutical ingredient (API) in detail. Different forms of Bepotastine DMFs exist exist since differing nations have different regulations, such as Bepotastine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bepotastine DMF submitted to regulatory agencies in the US is known as a USDMF. Bepotastine USDMF includes data on Bepotastine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bepotastine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bepotastine suppliers with USDMF on PharmaCompass.
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