01 1UMICORE Argentina SA
01 1Lomustine
01 1Germany
Registration Number : 306MF10091
Registrant's Address : Calle 14, Nr. 229 (Lote 13), B1629MXA, Parque Industrial Pilar, Buenos Aires, Argenti...
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03
A Lomustine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lomustine, including repackagers and relabelers. The FDA regulates Lomustine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lomustine 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 Lomustine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lomustine supplier is an individual or a company that provides Lomustine active pharmaceutical ingredient (API) or Lomustine finished formulations upon request. The Lomustine suppliers may include Lomustine API manufacturers, exporters, distributors and traders.
click here to find a list of Lomustine 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 Lomustine Drug Master File in Japan (Lomustine JDMF) empowers Lomustine 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 Lomustine JDMF during the approval evaluation for pharmaceutical products. At the time of Lomustine 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 Lomustine suppliers with JDMF on PharmaCompass.
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