Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
01 1Faran Shimi Pharmaceutical
02 1Jinan Tantu Chemicals
03 1Baran Chemical and Pharmaceutical
04 1Chongqing Carelife Pharmaceutical
05 1Fuan Pharmaceutical
06 1Hetero Drugs
07 2MSN Laboratories
08 1Natco Pharma
09 1Parsian Pharamceutical
10 2Shouyuan Chemical
11 1Sterling Spa
12 1Teva Pharmaceutical Industries
13 1Viatris
14 1Yangtze River Pharmaceutical Group
15 1Zhejiang Huayi Pharmaceutical Co., Ltd.
16 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 8China
02 4India
03 3Iran
04 1Israel
05 1Italy
06 1U.S.A
01 5Active
02 13Blank
01 18Blank
01 18Blank
01 1WC-0014
02 1WC-0041
03 1WC-0349
04 15Blank
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39898
Submission : 2024-04-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-01-21
Pay. Date : 2015-11-06
DMF Number : 29870
Submission : 2015-11-03
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0033
Start Marketing Date : 2015-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-03-14
Registration Number : 434-45-ND
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), Sangareddy District, Telangana, 502 300, India.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36838
Submission : 2022-03-30
Status : Active
Type : II
NDC Package Code : 54893-0033
Start Marketing Date : 2015-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-03-14
Registration Number : 434-45-ND
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), Sangareddy District, Telangana, 502 300, India.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-06
Pay. Date : 2016-05-02
DMF Number : 30490
Submission : 2016-05-13
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0092
Start Marketing Date : 2012-09-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-08-14
Pay. Date : 2023-05-08
DMF Number : 38197
Submission : 2023-04-26
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm :
Registrant Name : Klasia Co., Ltd.
Registration Date : 2019-05-29
Registration Number : Su758-2-ND
Manufacturer Name : Natco Pharma Limited
Manufacturer Address : Chemical Division Mekaguda Village Nandigama Mandal Rangareddy District, Telangana, India
A Regorafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regorafenib, including repackagers and relabelers. The FDA regulates Regorafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regorafenib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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