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
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PharmaCompass offers a list of Vortioxetine Hydrobromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Vortioxetine Hydrobromide manufacturer or Vortioxetine Hydrobromide supplier for your needs.
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PharmaCompass also assists you with knowing the Vortioxetine Hydrobromide API Price utilized in the formulation of products. Vortioxetine Hydrobromide API Price is not always fixed or binding as the Vortioxetine Hydrobromide Price is obtained through a variety of data sources. The Vortioxetine Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TRINTELLIX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRINTELLIX, including repackagers and relabelers. The FDA regulates TRINTELLIX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRINTELLIX API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A TRINTELLIX supplier is an individual or a company that provides TRINTELLIX active pharmaceutical ingredient (API) or TRINTELLIX finished formulations upon request. The TRINTELLIX suppliers may include TRINTELLIX API manufacturers, exporters, distributors and traders.
click here to find a list of TRINTELLIX 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 TRINTELLIX Drug Master File in Japan (TRINTELLIX JDMF) empowers TRINTELLIX 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 TRINTELLIX JDMF during the approval evaluation for pharmaceutical products. At the time of TRINTELLIX JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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