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 1Macsen Labs
05 1Anmol Chemicals
06 1ChemCon GmbH
07 1GLAND PHARMA LIMITED
08 1Global Calcium
09 1Harman Finochem
10 1Hetero Drugs
11 1Maithri Drugs
12 1Raks Pharma
13 1SNA Healthcare
14 1Sun Pharmaceutical Industries Limited
15 1TopChem Pharmaceuticals
01 1Germany
02 12India
03 1Ireland
04 1U.S.A
01 13Active
02 2Blank
01 15Blank
01 15Blank
01 15Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-27
Pay. Date : 2021-07-15
DMF Number : 35826
Submission : 2021-07-02
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-28
Pay. Date : 2022-02-22
DMF Number : 36091
Submission : 2021-07-01
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-09
Pay. Date : 2022-07-01
DMF Number : 36958
Submission : 2022-06-07
Status : Active
Type : II
NDC Package Code : 42765-029
Start Marketing Date : 2021-03-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39348
Submission : 2023-12-27
Status : Active
Type : II
NDC Package Code : 73379-103
Start Marketing Date : 2023-03-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-20
Pay. Date : 2023-09-27
DMF Number : 37650
Submission : 2023-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38226
Submission : 2023-03-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-03-07
Pay. Date : 2024-02-02
DMF Number : 39443
Submission : 2024-01-25
Status : Active
Type : II
NDC Package Code : 65977-0146
Start Marketing Date : 2019-04-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36372
Submission : 2021-10-09
Status : Active
Type : IV
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-30
Pay. Date : 2022-12-07
DMF Number : 37486
Submission : 2022-10-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-26
Pay. Date : 2023-10-04
DMF Number : 38899
Submission : 2023-10-10
Status : Active
Type : II
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