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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PharmaCompass also assists you with knowing the Lovastatin API Price utilized in the formulation of products. Lovastatin API Price is not always fixed or binding as the Lovastatin Price is obtained through a variety of data sources. The Lovastatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rodatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rodatin, including repackagers and relabelers. The FDA regulates Rodatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rodatin 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 Rodatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rodatin supplier is an individual or a company that provides Rodatin active pharmaceutical ingredient (API) or Rodatin finished formulations upon request. The Rodatin suppliers may include Rodatin API manufacturers, exporters, distributors and traders.
click here to find a list of Rodatin 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 Rodatin Drug Master File in Japan (Rodatin JDMF) empowers Rodatin 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 Rodatin JDMF during the approval evaluation for pharmaceutical products. At the time of Rodatin 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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