Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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01 1Minakem
02 1Gonane Pharma
03 1Axplora
04 1Minakem (formerly Delmar Chemicals)
05 1LGM Pharma
06 1Jinan Tantu Chemicals
07 1Capital Farma
08 2TAPI Technology & API Services
09 1Sumar Biotech
10 1Shamrock Pharmachemi
11 1Ajinomoto Company
12 1AstraZeneca
13 2BDR Lifesciences
14 1CHEMO
15 1Chongqing Huapont Pharmaceutical
16 1Fujian South Pharmaceutical
17 1GLAND CHEMICALS PRIVATE LIMITED
18 1GLAND PHARMA LIMITED
19 1Guangzhou Topwork Chemical
20 1Guangzhou Tosun Pharmaceutical
21 1Hangzhou Jiuyuan Gene Engineering
22 1Hangzhou Longshine Bio-Tech
23 1Hansoh Pharma
24 1Hanways Chempharm
25 2Industriale Chimica
26 1Jiangsu Sinopep Allsino Biopharmaceutical
27 1Lianyungang Runzhong Pharmaceutical Co Ltd
28 1Maharshi Pharma Chem
29 1Sakar Healthcare
30 1ScinoPharm Taiwan Ltd
31 1Shouyuan Chemical
32 1Sicor
33 1Sicor Societa Italiana Corticosteroidi Srl
34 1Sterling Chemical Malta
35 2Sterling Spa
36 1Steroid SpA
37 1Sun Pharmaceutical Industries Limited
38 1Tecoland Corporation
39 1Teva Pharmaceutical Industries
40 1Xian Libang Pharmaceutical Co.,Ltd
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01 1Canada
02 13China
03 1France
04 1Germany
05 10India
06 3Israel
07 7Italy
08 1Japan
09 1Malta
10 2Spain
11 1Taiwan
12 2U.S.A
13 1United Kingdom
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01 12Active
02 1Inactive
03 31Blank
01 9Valid
02 35Blank
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01 1303MF10021
02 1303MF10127
03 42Blank
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01 1WC-0159nA2
02 1WC-0340
03 1WC-0353
04 1WC-0570
05 1WC-340n
06 39Blank
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01 1No. 249-7-ND(A)
02 1No. 661-4-ND
03 1No. 936-1-ND
04 1Su248-17-ND
05 1Su249-7-ND
06 1Su3042-8-ND
07 1Su532-9-ND
08 37Blank
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01 146439-8769
02 150923-0416
03 153183-9305
04 159057-003
05 161662-0011
06 163190-0300
07 164918-1402
08 165129-2149
09 166529-0014
10 169910-0001
11 176177-053
12 33Blank
01 44Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Certificate Number : CEP 2024-002 - Rev 00
Issue Date : 2024-10-15
Type : Chemical
Substance Number : 2443
Status : Valid
NDC Package Code : 69910-0001
Start Marketing Date : 2015-06-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2014-10-24
Registration Number : Su3042-8-ND
Manufacturer Name : Minakem High Potent SA
Manufacturer Address : Rue Fonds Jean Paques, 8, Mont-Saint-Guibert, 1435, Belgium
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-29
Pay. Date : 2020-07-17
DMF Number : 32949
Submission : 2018-07-27
Status : Active
Type : II
Certificate Number : R1-CEP 2016-169 - Rev 00
Issue Date : 2023-02-22
Type : Chemical
Substance Number : 2443
Status : Valid
NDC Package Code : 46439-8769
Start Marketing Date : 2020-07-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22174
Submission : 2008-11-12
Status : Inactive
Type : II
Certificate Number : R1-CEP 2013-255 - Rev 02
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 2443
Status : Valid
Available Reg Filing : CA, ASMF |
Date of Issue : 2023-09-29
Valid Till : 2026-09-28
Written Confirmation Number : WC-0570
Address of the Firm :
66
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