Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1Metrochem API Private Limited
03 1PCAS
04 1Gonane Pharma
05 1Arihantanam Life Care
06 1Aurobindo Pharma Limited
07 1Biesterfeld Spezialchemie GmbH
08 1CHEMO
09 1Dishman Carbogen Amcis
10 1ENAL DRUGS
11 2Emcure Pharmaceuticals
12 1Esteve Quimica
13 1Everest Organics
14 1Fuan Pharmaceutical
15 1Glenmark Life Sciences
16 1Glenmark Pharmaceuticals
17 1Green Stone Swiss Co ., Ltd
18 1Guangzhou Tosun Pharmaceutical
19 1Hainan Poly Pharm
20 1Hetero Drugs
21 1Integrin Life Sciences
22 1Jiangsu Zhongbang Pharmaceutical Co, Ltd
23 2Jubilant Generics
24 1Jubilant Pharmova
25 1Lee Pharma
26 1Lunan Pharmaceutical
27 2MSN Laboratories
28 1Mac-Chem Products (India) Pvt.Ltd
29 2Nosch Labs Pvt
30 1Rajasthan Antibiotics
31 1Reyoung pharmaceutical
32 1SINTENOVO, S.A. DE C.V.
33 1Sailong Pharmaceutical
34 1Shouguang Fukang Pharmaceutical Co., Ltd
35 1Shouyuan Chemical
36 1Smilax Laboratories Limited
37 1Sterile India Pvt. Ltd
38 1Sun Pharmaceutical Industries Limited
39 1Tecoland Corporation
40 1UQUIFA
41 1Vaishali Pharma Ltd
42 1Yangtze River Pharmaceutical Group
43 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.
44 1Zydus Lifesciences
01 12China
02 2France
03 1Germany
04 28India
05 1Mexico
06 3Spain
07 1U.S.A
01 13Active
02 3Inactive
03 32Blank
01 10Valid
02 1Withdrawn by Holder
03 37Blank
01 48Blank
01 1WC-0040
02 1WC-0057n
03 1WC-0092
04 1WC-0168
05 1WC-0186
06 1WC-0226
07 1WC-0275
08 1WC-0383A4
09 1WC-0383A8
10 1WC-0384
11 1WC-0384A3
12 1WC-0493
13 36Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2011-11-04
Registration Number : 20111104-127-H-192-07
Manufacturer Name : Minakem Dunkerque Production
Manufacturer Address : 224 avenue de la Dordogne Zone d'Entreprises du Nord Gracht 59640 Dunkerque, France
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Certificate Number : CEP 2020-214 - Rev 01
Issue Date : 2024-06-21
Type : Chemical
Substance Number : 2923
Status : Valid
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2019-11-05
Registration Number : 20171031-127-H-320-29(2)
Manufacturer Name : Metrochem API Private Limited
Manufacturer Address : Unit-Ⅰ, Plot. No. 62/C/6, Pipeline Road Phase-I, IDA, Jeedimetla, Quthbullapur Mandal, Medchal - Malkajgiri District – 500 055, Telangana, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28375
Submission : 2014-06-09
Status : Active
Type : II
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-05-21
Pay. Date : 2020-05-13
DMF Number : 23199
Submission : 2009-11-16
Status : Active
Type : II
Certificate Number : CEP 2020-393 - Rev 01
Issue Date : 2024-04-29
Type : Chemical
Substance Number : 2923
Status : Valid
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2016-05-20
Registration Number : 20160520-127-H-304-23
Manufacturer Name : Sun Pharmaceutical Industries Ltd.@[Partial Process Outsourcing (Manufacturer)_Stage Ⅰ]Sun Pharmaceutical Industries Ltd.
Manufacturer Address : Plot No. 24/2, 25, Phase-IV, GIDC Industrial Estate, Panoli - 394 116, District Bharuch, Gujarat State, India@A-7/A-8, MIDC, Industria Area, Ahmednagar-414 111, Maharashtra, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30075
Submission : 2015-12-30
Status : Active
Type : II
Certificate Number : R0-CEP 2020-061 - Rev 01
Issue Date : 2022-05-30
Type : Chemical
Substance Number : 2923
Status : Valid
Date of Issue : 2021-02-12
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A8
Address of the Firm :
NDC Package Code : 69766-004
Start Marketing Date : 2015-10-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-06-16
DMF Number : 23628
Submission : 2010-05-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29974
Submission : 2016-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30667
Submission : 2016-07-20
Status : Inactive
Type : II
Certificate Number : R0-CEP 2022-192 - Rev 00
Issue Date : 2022-08-08
Type : Chemical
Substance Number : 2923
Status : Valid
NDC Package Code : 49711-0119
Start Marketing Date : 2009-10-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2013-07-26
Registration Number : 20130422-127-H-230-10(1)
Manufacturer Name : Union Quimico Farmaceutica, SA
Manufacturer Address : Poligon Industrial Moli de les Planes, Font de Bocs S/N C-35, Km.57 08470 Sant Celoni (Barcelona)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21986
Submission : 2009-01-29
Status : Inactive
Type : II
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