Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 1Granules India Limited
02 1ChemWerth Inc
03 1Metrochem API Private Limited
04 1Nuray Chemicals Private Limited
05 1Aptra Synthesis
06 1USV Private Limited
07 1Beijing Mesochem Technology
08 1Beijing Sjar Technology Development
09 1DMFs Not Supported
10 1Fujian South Pharmaceutical
11 1Hiray Pharma Solutions
12 1Kimia Biosciences
13 1MSN Laboratories
14 1Reyoung pharmaceutical
15 1Viatris
16 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 6China
02 7India
03 2U.S.A
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01 2Active
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01 16Blank
01 16Blank
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 58159-100
Start Marketing Date : 2024-02-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38491
Submission : 2023-06-26
Status : Active
Type : II
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 : 35784
Submission : 2021-03-31
Status : Active
Type : II
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