Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 2Chunghwa Chemical Synthesis & Biotech Co. , Ltd.
02 1CONCORD BIOTECH LIMITED.
03 1Novo Nordisk Production Ireland Limited
01 1Rapamycin (production only)
02 1Rapamycin NanoCrystal Colloidal Dispersion, 150g / Kg
03 1Sirolimus
04 1Sirolimus (for manufacturing only)
01 1India
02 1Ireland
03 2Taiwan
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Registration Number : 303MF10065
Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan
Initial Date of Registration : 2021-04-13
Latest Date of Registration : 2024-10-02
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Rapamycin (for manufacturing purposes only)
Registration Number : 224MF10198
Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan
Initial Date of Registration : 2012-09-13
Latest Date of Registration : 2024-10-02
Rapamycin NanoCrystal Colloidal Dispersion, 150g/kg
Registration Number : 225MF10176
Registrant's Address : Floor 1, The Crescent Building, Northwood Park, Northwood, Dublin 9, Co. Dublin, Irel...
Initial Date of Registration : 2013-09-18
Latest Date of Registration : 2018-07-03
Sirolimus (for manufacturing purposes only)
Registration Number : 302MF10039
Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA
Initial Date of Registration : 2020-04-02
Latest Date of Registration : 2020-04-02
A Sirolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sirolimus, including repackagers and relabelers. The FDA regulates Sirolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sirolimus 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 Sirolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sirolimus supplier is an individual or a company that provides Sirolimus active pharmaceutical ingredient (API) or Sirolimus finished formulations upon request. The Sirolimus suppliers may include Sirolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Sirolimus 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 Sirolimus Drug Master File in Japan (Sirolimus JDMF) empowers Sirolimus 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 Sirolimus JDMF during the approval evaluation for pharmaceutical products. At the time of Sirolimus 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 Sirolimus suppliers with JDMF on PharmaCompass.
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