Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 1Omgene Life Sciences Pvt. Ltd
02 1LGM Pharma
03 1Symbiotec Pharmalab
04 1Gonane Pharma
05 1Medichem S.A
06 1Shanghai Minbiotech
07 1TAPI Technology & API Services
08 1Astellas Pharma
09 1Aurobindo Pharma Limited
10 1Biocon
11 2BrightGene Bio-Medical Technology Co.,Ltd
12 1Chongqing DaXin Pharmaceutical
13 1Concord Biotech
14 1Guangzhou Tosun Pharmaceutical
15 1Gufic Biosciences
16 2Hansoh Pharma
17 1Hetero Drugs
18 1Kaliberr Labs
19 1MSN Laboratories
20 1Mac-Chem Products (India) Pvt.Ltd
21 1Shanghai Techwell Biopharma.Co., Ltd.
22 1Shenzhen Haorui
23 1Sumar Biotech
24 1Tecoland Corporation
25 1Tianwei Biotech Group
26 1Yacht Bio-Technology
27 1Yung Shin Pharmaceutical Industrial
28 1Zhejiang Hisun Pharmaceutical
29 1Zhejiang Huida Biotech
01 14China
02 12India
03 1Israel
04 1Japan
05 1Spain
06 2U.S.A
01 11Active
02 1Inactive
03 19Blank
01 31Blank
01 1229MF10162
02 1230MF10166
03 1230MF10169
04 1301MF10054
05 1303MF10069
06 26Blank
01 1WC-0100N1
02 1WC-0256
03 29Blank
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-20
Pay. Date : 2016-06-02
DMF Number : 30558
Submission : 2016-06-06
Status : Active
Type : II
NDC Package Code : 16436-0114
Start Marketing Date : 2014-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-29
Pay. Date : 2018-05-14
DMF Number : 32812
Submission : 2018-06-17
Status : Active
Type : II
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-23
Pay. Date : 2013-09-13
DMF Number : 27435
Submission : 2013-09-25
Status : Active
Type : II
NDC Package Code : 58623-0113
Start Marketing Date : 2018-04-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12856
Submission : 1998-02-11
Status : Active
Type : II
Registrant Name : Astellas Pharma Korea Co., Ltd.
Registration Date : 2006-05-11
Registration Number : Number 118-1-ND
Manufacturer Name : Astellas Pharma Inc. Toyama Technology Center
Manufacturer Address : 2-178, Kojin-machi, Toyama-city, Toyama 930-0809, Japan (3-11, Nihenbashi-honcho 2chome, Chuo-ku, Tokyo 103-8411, Japan)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29662
Submission : 2015-09-29
Status : Inactive
Type : II
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