01 1Musashino Chemical Laboratory Co., Ltd.
01 1Japanese Pharmacopoeia lactic acid (production only)
01 1Japan
Japanese Pharmacopoeia Lactic Acid (for manufacturing only)
Registration Number : 218MF10593
Registrant's Address : 1-8-2 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2006-06-22
A Lactic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactic Acid, including repackagers and relabelers. The FDA regulates Lactic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactic Acid 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 Lactic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lactic Acid supplier is an individual or a company that provides Lactic Acid active pharmaceutical ingredient (API) or Lactic Acid finished formulations upon request. The Lactic Acid suppliers may include Lactic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Lactic Acid 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 Lactic Acid Drug Master File in Japan (Lactic Acid JDMF) empowers Lactic Acid 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 Lactic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Lactic Acid 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 Lactic Acid suppliers with JDMF on PharmaCompass.
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