01 1Amano Enzyme Co., Ltd.
01 1Japanese Pharmacopoeia Aspergillus production galactosidase (production only)
01 1United Kingdom
Japanese Pharmacopoeia β-galactosidase (Aspergillus) (for manufacturing only)
Registration Number : 217MF10683
Registrant's Address : 2-7 Nishiki 1-chome, Naka-ku, Nagoya City, Aichi Prefecture
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2010-02-12
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PharmaCompass offers a list of Lovastatin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lovastatin manufacturer or Lovastatin supplier for your needs.
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A Mevacor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mevacor, including repackagers and relabelers. The FDA regulates Mevacor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mevacor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Mevacor supplier is an individual or a company that provides Mevacor active pharmaceutical ingredient (API) or Mevacor finished formulations upon request. The Mevacor suppliers may include Mevacor API manufacturers, exporters, distributors and traders.
click here to find a list of Mevacor 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 Mevacor Drug Master File in Japan (Mevacor JDMF) empowers Mevacor 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 Mevacor JDMF during the approval evaluation for pharmaceutical products. At the time of Mevacor JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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