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 1Jinan Tantu Chemicals
04 1Macsen Labs
05 1Agno Pharma
06 1Aurobindo Pharma Limited
07 2Azico Biophore India Pvt. Ltd
08 1Dishman Carbogen Amcis
09 1Emcure Pharmaceuticals
10 1Hetero Drugs
11 1Icrom
12 1MSN Laboratories
13 1SAFC
14 1Suven Pharmaceuticals
15 1Viatris
01 1China
02 10India
03 1Italy
04 4U.S.A
01 8Active
02 1Inactive
03 7Blank
01 16Blank
01 16Blank
01 1WC-0404
02 1WC-0404A2
03 14Blank
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 : Reviewed
Rev. Date : 2016-01-08
Pay. Date : 2015-09-29
DMF Number : 29829
Submission : 2015-09-29
Status : Active
Type : II
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-04
Pay. Date : 2019-07-31
DMF Number : 33199
Submission : 2018-09-28
Status : Active
Type : II
NDC Package Code : 14593-937
Start Marketing Date : 2023-09-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34975
Submission : 2020-07-15
Status : Active
Type : II
NDC Package Code : 57821-003
Start Marketing Date : 2020-04-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-02
Pay. Date : 2017-05-19
DMF Number : 31226
Submission : 2016-12-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-12
Pay. Date : 2023-09-01
DMF Number : 37258
Submission : 2022-07-16
Status : Active
Type : II
NDC Package Code : 68022-7525
Start Marketing Date : 2020-12-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21883
Submission : 2008-08-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20891
Submission : 2007-09-27
Status : Inactive
Type : II
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