Veranova: A CDMO that manages complexity with confidence.
01 1Macfarlan Smith Limited
01 1Methylphenidate Hydrochloride
01 1U.S.A
Veranova: A CDMO that manages complexity with confidence.
Registration Number : 302MF10009
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2020-01-17
Latest Date of Registration : 2020-01-17
A Concerta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Concerta, including repackagers and relabelers. The FDA regulates Concerta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Concerta 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 Concerta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Concerta supplier is an individual or a company that provides Concerta active pharmaceutical ingredient (API) or Concerta finished formulations upon request. The Concerta suppliers may include Concerta API manufacturers, exporters, distributors and traders.
click here to find a list of Concerta 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 Concerta Drug Master File in Japan (Concerta JDMF) empowers Concerta 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 Concerta JDMF during the approval evaluation for pharmaceutical products. At the time of Concerta 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 Concerta suppliers with JDMF on PharmaCompass.
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