Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
01 1Supriya Lifescience
02 2Bajaj Healthcare
03 1Bakul Group
04 2CSPC New Nova Pharmaceutical
05 1CSPC Pharmaceutical Group
06 1GGC Chemicals and Pharmaceuticals
07 1Mangalmurti Bio-chem
01 3China
02 6India
01 1Active
02 8Blank
01 1Expired
02 1Withdrawn by EDQM Failure to CEP procedure
03 7Blank
01 9Blank
01 1WC-0218
02 1WC-0277
03 1WC-0277A2
04 1WC-0375
05 5Blank
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
Registrant Name : Hiple Co., Ltd.
Registration Date : 2017-11-28
Registration Number : 20171128-205-I-525-02
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC, Taluka - Khed, District - Ratnagiri, Maharashtra State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39064
Submission : 2024-04-03
Status : Active
Type : II
Date of Issue : 2021-06-14
Valid Till : 2024-06-13
Written Confirmation Number : WC-0277
Address of the Firm :
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-205-I-605-04
Manufacturer Name : Bajaj Healthcare Limited (Unit-2)
Manufacturer Address : Block No. 588, Savli Karachia Road, At & Post – Gothada, Tal-Savli, Dist – Vadodara – 391 776, India
Certificate Number : R0-CEP 2010-168 - Rev 00
Issue Date : 2011-07-27
Type : Chemical
Substance Number :
Status : Withdrawn by EDQM F...
Registrant Name : Hiple Co., Ltd.
Registration Date : 2021-08-30
Registration Number : 20111202-205-I-16-12(5)
Manufacturer Name : CSPC Innovation Pharmaceutical co.,ltd
Manufacturer Address : No.62 Zhangju Road, Luancheng County, Shijiazhuang City, Hebei Province, China
Date of Issue : 2021-06-14
Valid Till : 2024-06-13
Written Confirmation Number : WC-0277A2
Address of the Firm :
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-205-I-605-04
Manufacturer Name : Bajaj Healthcare Limited (Unit-2)
Manufacturer Address : Block No. 588, Savli Karachia Road, At & Post – Gothada, Tal-Savli, Dist – Vadodara – 391 776, India
Date of Issue : 2023-02-02
Valid Till : 2025-09-13
Written Confirmation Number : WC-0375
Address of the Firm :
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2018-02-02
Registration Number : 20180202-205-I-560-03
Manufacturer Name : BAKUL PHARMA PRIVATE LIMITED
Manufacturer Address : Plot No. 6202, GIDC, City : Ankleshwar-393 002, Dist : Bharuch, Gujarat state, India
Certificate Number : R0-CEP 2014-228 - Rev 00
Issue Date : 2016-05-20
Type : Chemical
Substance Number :
Status : Expired
Registrant Name : Hiple Co., Ltd.
Registration Date : 2021-08-30
Registration Number : 20111202-205-I-16-12(5)
Manufacturer Name : CSPC Innovation Pharmaceutical co.,ltd
Manufacturer Address : No.62 Zhangju Road, Luancheng County, Shijiazhuang City, Hebei Province, China
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A CAS-83-67-0 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-83-67-0, including repackagers and relabelers. The FDA regulates CAS-83-67-0 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-83-67-0 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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