01 1HETERO DRUGS LIMITED.
01 1Lurasidone Hydrochloride
01 1India
Registration Number : 304MF10151
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2022-12-07
Latest Date of Registration : 2022-12-07
A Lurasidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurasidone, including repackagers and relabelers. The FDA regulates Lurasidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurasidone 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 Lurasidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurasidone supplier is an individual or a company that provides Lurasidone active pharmaceutical ingredient (API) or Lurasidone finished formulations upon request. The Lurasidone suppliers may include Lurasidone API manufacturers, exporters, distributors and traders.
click here to find a list of Lurasidone 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 Lurasidone Drug Master File in Japan (Lurasidone JDMF) empowers Lurasidone 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 Lurasidone JDMF during the approval evaluation for pharmaceutical products. At the time of Lurasidone 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 Lurasidone suppliers with JDMF on PharmaCompass.
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