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 1Astellas Pharma
08 1Aurobindo Pharma Limited
09 1Biocon
10 2BrightGene Bio-Medical Technology Co.,Ltd
11 1Chongqing DaXin Pharmaceutical
12 1Concord Biotech
13 1Guangzhou Tosun Pharmaceutical
14 1Gufic Biosciences
15 2Hansoh Pharma
16 1Hetero Drugs
17 1Kaliberr Labs
18 1MSN Laboratories
19 1Mac-Chem Products (India) Pvt.Ltd
20 1Shanghai Techwell Biopharma.Co., Ltd.
21 1Shenzhen Haorui
22 1Sumar Biotech
23 1TAPI Technology & API Services
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 : 2020-09-01
Pay. Date : 2020-08-07
DMF Number : 34888
Submission : 2020-07-31
Status : Active
Type : II
Registration Number : 301MF10054
Registrant's Address : No. 1191, Sec. 1, Chung Shan Rd. , Tachia, Taichung, Taiwan, R. O. C.
Initial Date of Registration : 2019-08-28
Latest Date of Registration : --
NDC Package Code : 63126-908
Start Marketing Date : 2020-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-06
Pay. Date : 2022-10-25
DMF Number : 35657
Submission : 2021-03-30
Status : Active
Type : II
NDC Package Code : 69766-090
Start Marketing Date : 2021-03-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 29662
Submission : 2015-09-29
Status : Inactive
Type : II
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