TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 1TAPI Hungary Industries Ltd.
02 1Kyongbo Pharmaceutical Co. , Ltd.
03 1LUPIN LIMITED.
04 1Ohara Pharmaceutical Co., Ltd.
05 1Shaoxing Jingxin Pharmaceutical Co. , Ltd.
06 1Zhejiang Jiangbei Pharmaceutical Co. , Ltd.
01 1SIMVAStatIN-C EXCLUSIVE USE FOR MANUFACTURE
02 4Simvastatin
03 1Simvastatin "Teva"
01 2China
02 1India
03 1Israel
04 1Japan
05 1South Korea
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registration Number : 218MF10581
Registrant's Address : 13 Pallagi u(´)t, Debrecen, 4042-Hungary
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2010-07-26
Registration Number : 220MF10215
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2008-10-17
Latest Date of Registration : 2008-10-17
Registration Number : 303MF10075
Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 4...
Initial Date of Registration : 2021-05-10
Latest Date of Registration : 2021-05-10
Registration Number : 217MF11215
Registrant's Address : 121-15 Toriiino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-08-26
Registration Number : 228MF10102
Registrant's Address : Dongdai Village, Zhang'an Street, Jiaojiang Zone, Taizhou City, Zhejiang Province, P....
Initial Date of Registration : 2016-05-27
Latest Date of Registration : 2021-09-02
SIMVASTATIN-C EXCLUSIVE USE FOR MANUFACTURE
Registration Number : 302MF10018
Registrant's Address : No. 31, Weisan Road, Hangzhou Bay Shangyu Economic and Technological Development Area...
Initial Date of Registration : 2020-01-31
Latest Date of Registration : 2022-08-03
A Simvastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simvastatin, including repackagers and relabelers. The FDA regulates Simvastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simvastatin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Simvastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Simvastatin supplier is an individual or a company that provides Simvastatin active pharmaceutical ingredient (API) or Simvastatin finished formulations upon request. The Simvastatin suppliers may include Simvastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Simvastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Simvastatin Drug Master File in Japan (Simvastatin JDMF) empowers Simvastatin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Simvastatin JDMF during the approval evaluation for pharmaceutical products. At the time of Simvastatin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Simvastatin suppliers with JDMF on PharmaCompass.
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