01 1SpecGx LLC
01 1Methadone hydrochloride
01 1Ireland
Registration Number : 223MF10179
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2011-12-27
Latest Date of Registration : 2012-09-14
A Methadone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methadone Hydrochloride, including repackagers and relabelers. The FDA regulates Methadone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methadone Hydrochloride 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 Methadone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methadone Hydrochloride supplier is an individual or a company that provides Methadone Hydrochloride active pharmaceutical ingredient (API) or Methadone Hydrochloride finished formulations upon request. The Methadone Hydrochloride suppliers may include Methadone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Methadone Hydrochloride 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 Methadone Hydrochloride Drug Master File in Japan (Methadone Hydrochloride JDMF) empowers Methadone Hydrochloride 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 Methadone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Methadone Hydrochloride 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 Methadone Hydrochloride suppliers with JDMF on PharmaCompass.
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