Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1Minakem (formerly Delmar Chemicals)
03 1LGM Pharma
04 1Faran Shimi Pharmaceutical
05 1Shandong Loncom Pharmaceutical
06 1Granules India Limited
07 1Acebright India Pharma Private Limited
08 2Alembic Pharmaceuticals Limited
09 1Anhui HaiKang Pharmaceutical
10 1Aspire Lifesciences Pvt Ltd
11 1Aurobindo Pharma Limited
12 2BDR Lifesciences
13 1Baran Chemical and Pharmaceutical
14 1Biotechnica DWC
15 1Brawn Laboratories Ltd
16 1Bulat Pharmaceutical
17 1Cdymax
18 1Chengda Pharmaceuticals
19 1Chongqing Carelife Pharmaceutical
20 4Cipla
21 1Estechpharma
22 1Fujian South Pharmaceutical
23 1Guangzhou Tosun Pharmaceutical
24 1Hetero Drugs
25 1Jeil Pharmaceutical Co., Ltd
26 1Jin Dun Medical
27 1KriSan Biotech
28 3MSN Laboratories
29 1Mac-Chem Products (India) Pvt.Ltd
30 1Mehta API
31 1Nanjing Bold Chemical
32 2Natco Pharma
33 1Qilu Pharmaceutical
34 1Reliance Life Sciences Private Limited
35 1Sakar Healthcare
36 1Shandong Anhong Pharmaceutical
37 1Shanvr Life Sciences
38 2Shilpa Medicare
39 1Shouyuan Chemical
40 1Sichuan Xieli Pharmaceutical
41 1Stason Pharmaceuticals, Inc.
42 1Sumar Biotech
43 1Synthland
44 1Tecoland Corporation
45 1Teva API
46 1Teva Pharmaceutical Industries
47 1Vannsh Life Sciences
48 1Yabao Pharmaceutical Group Co. Ltd
49 1Zhejiang Jiuzhou Pharmaceutical
01 1Algeria
02 1Canada
03 15China
04 1France
05 30India
06 2Iran
07 2Israel
08 2South Korea
09 1Taiwan
10 3U.S.A
01 16Active
02 4Inactive
03 38Blank
01 2Valid
02 56Blank
01 1230MF10114
02 57Blank
01 1WC-0014
02 1WC-0041
03 1WC-0082
04 1WC-0082A8
05 1WC-0138
06 1WC-0147
07 1WC-0147A3
08 1WC-0198
09 1WC-0340A3
10 1WC-0349
11 1WC-340n
12 47Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-27
Pay. Date : 2018-01-19
DMF Number : 32140
Submission : 2017-12-20
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37229
Submission : 2022-06-30
Status : Active
Type : II
NDC Package Code : 62207-982
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-01
Pay. Date : 2016-02-01
DMF Number : 30234
Submission : 2016-02-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-18
Pay. Date : 2015-06-12
DMF Number : 29340
Submission : 2015-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26460
Submission : 2012-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27793
Submission : 2013-11-20
Status : Inactive
Type : II
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