Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
01 1Farmhispania S. A.
02 1Hetero Labs Limited
03 1KOLON LIFE SCIENCE, INC.
04 1Natco Pharma Limited.
05 1Synthon s. r. o.
01 1GEFITINIB
02 4Gefitinib
01 2India
02 1Netherlands
03 1South Korea
04 1Spain
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Registration Number : 230MF10029
Registrant's Address : Balmes 85, Atico, 08008 (Barcelona), Spain
Initial Date of Registration : 2018-02-15
Latest Date of Registration : 2018-02-15
Registration Number : 230MF10026
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2018-02-15
Latest Date of Registration : 2018-10-26
Registration Number : 229MF10151
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2017-08-04
Latest Date of Registration : 2017-08-04
Registration Number : 229MF10197
Registrant's Address : Natco House, Road No. 2, Banjara Hills,Hyderabad 500034, Telangana, India
Initial Date of Registration : 2017-11-09
Latest Date of Registration : 2021-09-02
Registration Number : 229MF10200
Registrant's Address : Brnenska 32/cp. 597 678 01 Blansko Czech Republic
Initial Date of Registration : 2017-11-14
Latest Date of Registration : 2021-10-21
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A Gefitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gefitinib, including repackagers and relabelers. The FDA regulates Gefitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gefitinib 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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A Gefitinib supplier is an individual or a company that provides Gefitinib active pharmaceutical ingredient (API) or Gefitinib finished formulations upon request. The Gefitinib suppliers may include Gefitinib API manufacturers, exporters, distributors and traders.
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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 Gefitinib Drug Master File in Japan (Gefitinib JDMF) empowers Gefitinib 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 Gefitinib JDMF during the approval evaluation for pharmaceutical products. At the time of Gefitinib JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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