Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Metrochem API Private Limited
03 1Virupaksha Organics
04 1Aurore Life Sciences
05 1Lee Pharma
06 1MSN Laboratories
07 1Symed Labs
01 5BILASTINE
02 1BILASTINE (FORM-I)
03 1BILASTINE (FORM-II)
01 7India
01 7Active
01 7Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
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DMF Number : 39332
Submission : 2023-12-29
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
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DMF Number : 36965
Submission : 2022-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 38752
Submission : 2024-02-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 39005
Submission : 2023-10-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 36288
Submission : 2021-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 33720
Submission : 2019-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38966
Submission : 2023-10-09
Status : Active
Type : II
A Bilastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bilastine, including repackagers and relabelers. The FDA regulates Bilastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bilastine 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 Bilastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bilastine supplier is an individual or a company that provides Bilastine active pharmaceutical ingredient (API) or Bilastine finished formulations upon request. The Bilastine suppliers may include Bilastine API manufacturers, exporters, distributors and traders.
click here to find a list of Bilastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bilastine DMF (Drug Master File) is a document detailing the whole manufacturing process of Bilastine active pharmaceutical ingredient (API) in detail. Different forms of Bilastine DMFs exist exist since differing nations have different regulations, such as Bilastine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bilastine DMF submitted to regulatory agencies in the US is known as a USDMF. Bilastine USDMF includes data on Bilastine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bilastine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bilastine suppliers with USDMF on PharmaCompass.
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