Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem Dunkerque Production
02 2Aspen Oss B. V.
03 1INDUSTRIALE CHIMICA s. r. l.
04 1Newchem S. p. A.
05 1Sicor Societa (') Italiana Corticosteroidi S. r. l.
06 1Sicor de Me(´)xico,S. A. de C. V.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registration Number : 301MF10045
Registrant's Address : 224 avenue de la Dordogne Zone d'Entreprises du Nord Gracht 59640 Dunkerque, France
Initial Date of Registration : 2019-08-20
Latest Date of Registration : 2019-10-25
Aspen API. More than just an API.
Registration Number : 305MF10040
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2023-03-29
Latest Date of Registration : 2023-03-29
Aspen API. More than just an API.
Registration Number : 301MF10061
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2019-09-11
Latest Date of Registration : 2022-10-19
A Symbicort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Symbicort, including repackagers and relabelers. The FDA regulates Symbicort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Symbicort 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 Symbicort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Symbicort supplier is an individual or a company that provides Symbicort active pharmaceutical ingredient (API) or Symbicort finished formulations upon request. The Symbicort suppliers may include Symbicort API manufacturers, exporters, distributors and traders.
click here to find a list of Symbicort 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 Symbicort Drug Master File in Japan (Symbicort JDMF) empowers Symbicort 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 Symbicort JDMF during the approval evaluation for pharmaceutical products. At the time of Symbicort 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 Symbicort suppliers with JDMF on PharmaCompass.
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