Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
01 1Minakem
02 1Minakem (formerly Delmar Chemicals)
03 1LGM Pharma
04 1Cohance Lifesciences
05 1Dr. Reddy's Laboratories
06 1Ami Lifesciences Private Limited
07 1HRV Global Life Sciences
08 1Hubei Gedian Humanwell Pharmaceutical
09 1Chunghwa Chemical Synthesis & Biotech
10 1Alkem Laboratories
11 1Arene Lifesciences
12 1Aurobindo Pharma Limited
13 2Bial
14 1CTX Lifesciences
15 1DEAFARMA
16 2Dasami Lab
17 1Glenmark Pharmaceuticals
18 1Guangzhou Tosun Pharmaceutical
19 1Hetero Drugs
20 1Hunan Huateng Pharmaceutical Co ltd
21 1Inner Mongolia Jingdong Pharmaceutical
22 1Jubilant Generics
23 1Jubilant Pharmova
24 1Lupin Ltd
25 1MSN Laboratories
26 1Shanghai Pharma Group
27 1Sun Pharmaceutical Industries Limited
28 1Tianjin Weijie Pharmaceutical Co., Ltd.
29 1Unichem Laboratories Limited
01 1Canada
02 6China
03 1France
04 18India
05 1Italy
06 2Portugal
07 1Taiwan
08 1U.S.A
01 16Active
02 1Inactive
03 14Blank
01 31Blank
01 31Blank
01 1WC-0011
02 1WC-0049
03 1WC-0054
04 1WC-0067
05 1WC-0092
06 1WC-0097
07 1WC-0195
08 1WC-0383
09 23Blank
Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-27
Pay. Date : 2017-06-09
DMF Number : 31791
Submission : 2017-06-05
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33028
Submission : 2018-08-09
Status : Active
Type : II
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 76072-1005
Start Marketing Date : 2016-05-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-05
Pay. Date : 2017-06-19
DMF Number : 31758
Submission : 2017-05-31
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-933
Start Marketing Date : 2017-05-31
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 : 38309
Submission : 2023-04-25
Status : Active
Type : II
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Available Reg Filing : ASMF, CN, MX |
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
NDC Package Code : 51508-014
Start Marketing Date : 2023-08-07
End Marketing Date : 2025-12-31
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39312
Submission : 2023-12-28
Status : Active
Type : II
NDC Package Code : 52076-6269
Start Marketing Date : 2021-02-01
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 : 22026
Submission : 2008-09-26
Status : Active
Type : II
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