01 1Sumitomo Chemical Co., Ltd.
01 1Japanese Pharmacopoeia afloqualone
01 1Japan
Japanese Pharmacopoeia Afloqualone
Registration Number : 217MF10077
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2007-09-06
A Metaqualone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metaqualone, including repackagers and relabelers. The FDA regulates Metaqualone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metaqualone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Metaqualone supplier is an individual or a company that provides Metaqualone active pharmaceutical ingredient (API) or Metaqualone finished formulations upon request. The Metaqualone suppliers may include Metaqualone API manufacturers, exporters, distributors and traders.
click here to find a list of Metaqualone 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 Metaqualone Drug Master File in Japan (Metaqualone JDMF) empowers Metaqualone 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 Metaqualone JDMF during the approval evaluation for pharmaceutical products. At the time of Metaqualone 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 Metaqualone suppliers with JDMF on PharmaCompass.
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