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 1TAPI Technology & API Services
08 1Acebright India Pharma Private Limited
09 2Alembic Pharmaceuticals Limited
10 1Anhui HaiKang Pharmaceutical
11 1Aspire Lifesciences Pvt Ltd
12 1Aurobindo Pharma Limited
13 2BDR Lifesciences
14 1Baran Chemical and Pharmaceutical
15 1Biotechnica DWC
16 1Brawn Laboratories Ltd
17 1Bulat Pharmaceutical
18 1Cdymax
19 1Chengda Pharmaceuticals
20 1Chongqing Carelife Pharmaceutical
21 4Cipla
22 1Estechpharma
23 1Fujian South Pharmaceutical
24 1Guangzhou Tosun Pharmaceutical
25 1Hetero Drugs
26 1Jeil Pharmaceutical Co., Ltd
27 1Jin Dun Medical
28 1KriSan Biotech
29 3MSN Laboratories
30 1Mac-Chem Products (India) Pvt.Ltd
31 1Mehta API
32 1Nanjing Bold Chemical
33 2Natco Pharma
34 1Parsian Pharamceutical
35 1Qilu Pharmaceutical
36 1Reliance Life Sciences Private Limited
37 1Sakar Healthcare
38 1Shandong Anhong Pharmaceutical
39 1Shanvr Life Sciences
40 2Shilpa Medicare
41 1Shouyuan Chemical
42 1Sichuan Xieli Pharmaceutical
43 1Stason Pharmaceuticals, Inc.
44 1Sumar Biotech
45 1Synthland
46 1Tecoland Corporation
47 1Teva Pharmaceutical Industries
48 1Vannsh Life Sciences
49 1Yabao Pharmaceutical Group Co. Ltd
50 1Zhejiang Jiuzhou Pharmaceutical
01 1Algeria
02 1Canada
03 15China
04 1France
05 30India
06 3Iran
07 2Israel
08 2South Korea
09 1Taiwan
10 3U.S.A
01 16Active
02 4Inactive
03 39Blank
01 3Valid
02 56Blank
01 1230MF10114
02 58Blank
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 48Blank
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 : 27793
Submission : 2013-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26460
Submission : 2012-09-18
Status : Inactive
Type : II
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