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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurasidone Hydrochloride, including repackagers and relabelers. The FDA regulates Lurasidone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurasidone Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurasidone Hydrochloride supplier is an individual or a company that provides Lurasidone Hydrochloride active pharmaceutical ingredient (API) or Lurasidone Hydrochloride finished formulations upon request. The Lurasidone Hydrochloride suppliers may include Lurasidone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Lurasidone Hydrochloride 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 Hydrochloride Drug Master File in Japan (Lurasidone Hydrochloride JDMF) empowers Lurasidone Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Lurasidone Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
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