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 1Dr. Reddy's Laboratories
04 1Ami Lifesciences Private Limited
05 1Alkem Laboratories
06 1Aurisco Pharmaceutical
07 1Aurobindo Pharma Limited
08 1Everest Organics
09 1HONOUR LAB LTD
10 1Lee Pharma
11 1Lunan Pharmaceutical
12 1Micro Labs Limited
13 1Optimus Pharma
14 1Blank
01 14BEMPEDOIC ACID
01 2China
02 11India
03 1Blank
01 14Active
01 9Complete
02 5Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38786
Submission : 2023-12-28
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 : Complete
Rev. Date : 2023-11-07
Pay. Date : 2023-09-22
DMF Number : 36085
Submission : 2021-07-05
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-28
Pay. Date : 2023-06-27
DMF Number : 36933
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37511
Submission : 2022-10-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-21
Pay. Date : 2022-03-21
DMF Number : 36942
Submission : 2022-04-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37973
Submission : 2023-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36010
Submission : 2021-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-09
Pay. Date : 2023-03-31
DMF Number : 37788
Submission : 2023-03-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-24
Pay. Date : 2021-06-11
DMF Number : 35956
Submission : 2021-06-11
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-18
Pay. Date : 2023-08-18
DMF Number : 36773
Submission : 2022-02-28
Status : Active
Type : II
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A Bempedoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bempedoic Acid, including repackagers and relabelers. The FDA regulates Bempedoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bempedoic Acid 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 Bempedoic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bempedoic Acid supplier is an individual or a company that provides Bempedoic Acid active pharmaceutical ingredient (API) or Bempedoic Acid finished formulations upon request. The Bempedoic Acid suppliers may include Bempedoic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Bempedoic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bempedoic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Bempedoic Acid active pharmaceutical ingredient (API) in detail. Different forms of Bempedoic Acid DMFs exist exist since differing nations have different regulations, such as Bempedoic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bempedoic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Bempedoic Acid USDMF includes data on Bempedoic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bempedoic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bempedoic Acid suppliers with USDMF on PharmaCompass.
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