01 1CDYMAX (INDIA) PHARMA PRIVATE LIMITED
01 1Sunitinib Malate
01 1India
Registration Number : 305MF10101
Registrant's Address : No. 77D & 116/117, KIADB Industrial Area, Jigani, Phase - 2, Anekal Taluk, Bangalore ...
Initial Date of Registration : 2023-08-30
Latest Date of Registration : 2023-08-30
A Sunitinib Malate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunitinib Malate, including repackagers and relabelers. The FDA regulates Sunitinib Malate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunitinib Malate 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 Sunitinib Malate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sunitinib Malate supplier is an individual or a company that provides Sunitinib Malate active pharmaceutical ingredient (API) or Sunitinib Malate finished formulations upon request. The Sunitinib Malate suppliers may include Sunitinib Malate API manufacturers, exporters, distributors and traders.
click here to find a list of Sunitinib Malate 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 Sunitinib Malate Drug Master File in Japan (Sunitinib Malate JDMF) empowers Sunitinib Malate 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 Sunitinib Malate JDMF during the approval evaluation for pharmaceutical products. At the time of Sunitinib Malate 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 Sunitinib Malate suppliers with JDMF on PharmaCompass.
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