Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.
01 1Phyton Biotech LLC
02 1TAPI Czech Industries s. r. o.
03 1Corden Pharma Boulder, Inc.
04 3INDENA S. p. A.
05 1Samyang Holdings Corporation
06 1ScinoPharm Taiwan, Ltd.
07 1Yunnan Hande Bio-Tech Co. , Ltd.
08 1Zhejiang Starry Pharmaceutical Co. ,Ltd
Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.
Registration Number : 224MF10111
Registrant's Address : 1527 Cliveden Avenue, Delta, BC, Canada, V3M6P7
Initial Date of Registration : 2012-07-04
Latest Date of Registration : 2020-06-19
TAPI offers customized CDMO Solutions for API development and manufacturing services.
Registration Number : 305MF10109
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2023-09-20
Latest Date of Registration : 2023-09-20
A OncoGel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of OncoGel, including repackagers and relabelers. The FDA regulates OncoGel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. OncoGel 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 OncoGel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A OncoGel supplier is an individual or a company that provides OncoGel active pharmaceutical ingredient (API) or OncoGel finished formulations upon request. The OncoGel suppliers may include OncoGel API manufacturers, exporters, distributors and traders.
click here to find a list of OncoGel 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 OncoGel Drug Master File in Japan (OncoGel JDMF) empowers OncoGel 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 OncoGel JDMF during the approval evaluation for pharmaceutical products. At the time of OncoGel 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 OncoGel suppliers with JDMF on PharmaCompass.
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