Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Cipla
03 1Blank
01 3TROFINETIDE
01 2India
02 1Blank
01 3Active
01 3Blank
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 : 43715
Submission : 2026-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43497
Submission : 2026-03-21
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43334
Submission : 2026-01-30
Status : Active
Type : II
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PharmaCompass offers a list of Trofinetide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Trofinetide manufacturer or Trofinetide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trofinetide manufacturer or Trofinetide supplier.
A Trofinetide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trofinetide, including repackagers and relabelers. The FDA regulates Trofinetide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trofinetide 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 Trofinetide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Trofinetide supplier is an individual or a company that provides Trofinetide active pharmaceutical ingredient (API) or Trofinetide finished formulations upon request. The Trofinetide suppliers may include Trofinetide API manufacturers, exporters, distributors and traders.
click here to find a list of Trofinetide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Trofinetide DMF (Drug Master File) is a document detailing the whole manufacturing process of Trofinetide active pharmaceutical ingredient (API) in detail. Different forms of Trofinetide DMFs exist exist since differing nations have different regulations, such as Trofinetide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trofinetide DMF submitted to regulatory agencies in the US is known as a USDMF. Trofinetide USDMF includes data on Trofinetide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trofinetide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trofinetide suppliers with USDMF on PharmaCompass.
We have 2 companies offering Trofinetide
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