ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Rochem International Inc
03 1Chongqing Sintaho Pharmaceutical
04 1HRV Global Life Sciences
05 1USV Private Limited
06 1Chunghwa Chemical Synthesis & Biotech
07 1Omgene Life Sciences Pvt. Ltd
08 1Auro Peptides Limited
09 1Aurobindo Pharma Limited
10 1MSN Laboratories
11 1Smaart Pharmaceutticals
01 1China
02 7India
03 1Taiwan
04 2U.S.A
01 3Active
02 8Blank
01 11Blank
01 11Blank
01 11Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-07
Pay. Date : 2021-03-24
DMF Number : 35768
Submission : 2021-07-22
Status : Active
Type : II
NDC Package Code : 62147-0281
Start Marketing Date : 2021-12-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6227
Start Marketing Date : 2017-08-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-11
Pay. Date : 2020-11-12
DMF Number : 35386
Submission : 2020-11-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-23
Pay. Date : 2020-09-01
DMF Number : 35097
Submission : 2020-09-01
Status : Active
Type : II
NDC Package Code : 69766-089
Start Marketing Date : 2020-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59651-513
Start Marketing Date : 2020-11-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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