Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1LGM Pharma
03 1Symbiotec Pharmalab
04 1DKSH
05 1Gonane Pharma
06 1Shanghai Minbiotech
07 2TAPI Technology & API Services
08 1Aurobindo Pharma Limited
09 1BrightGene Bio-Medical Technology Co.,Ltd
10 1Chongqing DaXin Pharmaceutical
11 1Concord Biotech
12 1GLAND PHARMA LIMITED
13 1Gufic Biosciences
14 1Jiangsu Hengrui Medicine
15 1Kaliberr Labs
16 1Lek Pharmaceuticals
17 1MSN Laboratories
18 1Shanghai Techwell Biopharma.Co., Ltd.
19 1Shenzhen Haorui
20 1Shenzhen JYMed Technology
21 1Shouyuan Chemical
22 1Sumar Biotech
23 1Tecoland Corporation
24 1Teva Pharmaceutical Industries
25 1Unipex
26 1Xellia Pharmaceuticals ApS
27 1Yacht Bio-Technology
28 1Zhejiang Huida Biotech
29 1Zhejiang Wild Wind Pharmaceutical Co
01 11China
02 1Denmark
03 1France
04 9India
05 3Israel
06 1Slovenia
07 1Switzerland
08 1Taiwan
09 2U.S.A
01 8Active
02 4Inactive
03 18Blank
01 30Blank
01 1305MF10081
02 29Blank
01 1WC-0002
02 1WC-0256
03 1WC-0383A8
04 1WC-0427A3-4
05 26Blank
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27585
Submission : 2013-11-27
Status : Active
Type : II
NDC Package Code : 52076-6230
Start Marketing Date : 2018-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Pharma Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-210-J-324
Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant
Manufacturer Address : 1, Tung-Hsing St., Shu-Lin, New Taipei City 23850, Taiwan
Available Reg Filing : ASMF |
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.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22770
Submission : 2009-05-12
Status : Inactive
Type : II
Registration Number : 305MF10081
Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida-201 308 (U.P.) India
Initial Date of Registration : 2023-07-12
Latest Date of Registration : --
Date of Issue : 2019-06-17
Valid Till : 2022-05-26
Written Confirmation Number : WC-0002
Address of the Firm :
NDC Package Code : 15894-0014
Start Marketing Date : 2017-11-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-17
Registration Number : 20210317-210-J-758
Manufacturer Name : Teva API India Private Limited
Manufacturer Address : Plot No.: A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula-244 235, Distt. Amroha (UP), INDIA
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-14
Pay. Date : 2013-03-20
DMF Number : 26978
Submission : 2013-06-21
Status : Active
Type : II
NDC Package Code : 15894-0014
Start Marketing Date : 2017-11-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-17
Registration Number : 20210317-210-J-758
Manufacturer Name : Teva API India Private Limited
Manufacturer Address : Plot No.: A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula-244 235, Distt. Amroha (UP), INDIA
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-19
Pay. Date : 2021-08-03
DMF Number : 35573
Submission : 2021-07-29
Status : Active
Type : II
NDC Package Code : 84517-053
Start Marketing Date : 2024-07-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34281
Submission : 2019-11-19
Status : Active
Type : II
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