ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Metrochem API Private Limited
04 1Granules India Limited
05 1Macsen Labs
06 1Alembic Pharmaceuticals Limited
07 1Amsa Spa
08 1Curia
09 1Lee Pharma
10 1Macleods Pharmaceuticals Limited
11 2Maithri Drugs
12 1Viyash Life Sciences
13 1Zydus Lifesciences
01 11India
02 1Italy
03 2U.S.A
01 11Active
02 3Blank
01 14Blank
01 14Blank
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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 : 39333
Submission : 2023-12-30
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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DMF Number : 40318
Submission : 2024-09-30
Status : Active
Type : II
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 40485
Submission : 2024-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
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Pay. Date :
DMF Number : 39715
Submission : 2024-06-04
Status : Active
Type : II
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Rev. Date :
Pay. Date :
DMF Number : 39799
Submission : 2024-05-29
Status : Active
Type : II
NDC Package Code : 17373-1021
Start Marketing Date : 2024-05-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 37560
Submission : 2022-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38637
Submission : 2023-08-25
Status : Active
Type : II
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