Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
01 1Farmhispania
02 1ChemWerth Inc
03 1LGM Pharma
04 2Dr. Reddy's Laboratories
05 1Chunghwa Chemical Synthesis & Biotech
06 1Omgene Life Sciences Pvt. Ltd
07 1BrightGene Bio-Medical Technology Co.,Ltd
08 1Concord Biotech
09 1Guangzhou Tosun Pharmaceutical
10 1Hetero Drugs
11 1Hubei Honch Pharmaceutical
12 1MSN Laboratories
13 1Procos
14 1Sumar Biotech
15 1TAPI Technology & API Services
16 1Teva Pharmaceutical Industries
17 1Zhejiang Huida Biotech
01 4China
02 7India
03 2Israel
04 1Italy
05 1Spain
06 1Taiwan
07 2U.S.A
01 10Active
02 8Blank
01 18Blank
01 18Blank
01 1WC-0111A3
02 1WC-0349
03 16Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-28
Pay. Date : 2021-05-05
DMF Number : 35562
Submission : 2021-05-05
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-26
Pay. Date : 2020-09-21
DMF Number : 34665
Submission : 2020-03-31
Status : Active
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36640
Submission : 2021-12-29
Status : Active
Type : II
NDC Package Code : 52076-6262
Start Marketing Date : 2019-05-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35231
Submission : 2020-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34522
Submission : 2020-01-31
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0094
Start Marketing Date : 2020-01-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-02
Pay. Date : 2020-10-09
DMF Number : 35289
Submission : 2020-11-26
Status : Active
Type : II
NDC Package Code : 51846-1058
Start Marketing Date : 2019-11-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35281
Submission : 2020-11-20
Status : Active
Type : II
NDC Package Code : 46016-1200
Start Marketing Date : 2019-10-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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