01 1H. Lundbeck A/S
02 1Hetero Labs Limited
03 1Lundbeck Pharmaceuticals Italy S. p. A
01 2Vortioxetine Hydrobromide
02 1Vortioxetine hydrobromide [D]
01 2Denmark
02 1India
Registration Number : 230MF10077
Registrant's Address : Ottiliavej 9, DK-2500 Valby, Copenhagen, Denmark
Initial Date of Registration : 2018-07-03
Latest Date of Registration : 2021-11-02
Registration Number : 230MF10076
Registrant's Address : Via Quarta Strada, 2 Padova, Italy
Initial Date of Registration : 2018-07-03
Latest Date of Registration : 2021-11-02
Registration Number : 304MF10041
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2022-02-24
Latest Date of Registration : 2022-02-24
A Vortioxetine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vortioxetine, including repackagers and relabelers. The FDA regulates Vortioxetine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vortioxetine 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 Vortioxetine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vortioxetine supplier is an individual or a company that provides Vortioxetine active pharmaceutical ingredient (API) or Vortioxetine finished formulations upon request. The Vortioxetine suppliers may include Vortioxetine API manufacturers, exporters, distributors and traders.
click here to find a list of Vortioxetine 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 Vortioxetine Drug Master File in Japan (Vortioxetine JDMF) empowers Vortioxetine 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 Vortioxetine JDMF during the approval evaluation for pharmaceutical products. At the time of Vortioxetine 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 Vortioxetine suppliers with JDMF on PharmaCompass.
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