Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Omgene Life Sciences Pvt. Ltd
03 1Maithri Drugs
04 1Cipla
05 1Conscientia Industrial
06 1Corden Pharma Bergamo S.p.A
07 2F.I.S. Fabbrica Italiana Sintetici
08 1Flamma SpA
09 1Global Pharma Tek
10 1Sandoo Pharmaceuticals and Chemcials Co.,Ltd
11 1Viyash Life Sciences
12 1Zydus Lifesciences
13 1Blank
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01 2China
02 7India
03 4Italy
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01 3Active
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01 14Blank
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01 14Blank
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01 14Blank
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01 148087-0160
02 148087-0168
03 149964-0102
04 154236-120
05 173435-062
06 9Blank
01 14Blank
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
NDC Package Code : 73435-062
Start Marketing Date : 2025-11-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43334
Submission : 2026-01-30
Status : Active
Type : II

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43497
Submission : 2026-03-21
Status : Active
Type : II





NDC Package Code : 48087-0168
Start Marketing Date : 2025-03-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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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.
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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.
We have 12 companies offering Trofinetide
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