Aspen API. More than just an API.
01 1Aspen Oss B. V.
01 1Asenapine maleate
01 1Netherlands
Aspen API. More than just an API.
Registration Number : 227MF10107
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2015-04-09
Latest Date of Registration : 2020-11-30
A Asenapine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Asenapine Maleate, including repackagers and relabelers. The FDA regulates Asenapine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Asenapine Maleate 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 Asenapine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Asenapine Maleate supplier is an individual or a company that provides Asenapine Maleate active pharmaceutical ingredient (API) or Asenapine Maleate finished formulations upon request. The Asenapine Maleate suppliers may include Asenapine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Asenapine Maleate 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 Asenapine Maleate Drug Master File in Japan (Asenapine Maleate JDMF) empowers Asenapine Maleate 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 Asenapine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Asenapine Maleate 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 Asenapine Maleate suppliers with JDMF on PharmaCompass.
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