01 1PEPTIDO GmbH
02 1Sandoz GmbH
01 1Levothyroxine sodium
02 1Levothyroxine sodium hydrate
01 1Germany
02 1Switzerland
Registration Number : 221MF10168
Registrant's Address : Am Kraftwerk 6, D-66450 Bexbach, Germany
Initial Date of Registration : 2009-07-30
Latest Date of Registration : 2009-07-30
Registration Number : 217MF10456
Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria
Initial Date of Registration : 2005-08-24
Latest Date of Registration : 2017-12-06
A Levothyroxine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levothyroxine, including repackagers and relabelers. The FDA regulates Levothyroxine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levothyroxine 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 Levothyroxine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levothyroxine supplier is an individual or a company that provides Levothyroxine active pharmaceutical ingredient (API) or Levothyroxine finished formulations upon request. The Levothyroxine suppliers may include Levothyroxine API manufacturers, exporters, distributors and traders.
click here to find a list of Levothyroxine 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 Levothyroxine Drug Master File in Japan (Levothyroxine JDMF) empowers Levothyroxine 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 Levothyroxine JDMF during the approval evaluation for pharmaceutical products. At the time of Levothyroxine 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 Levothyroxine suppliers with JDMF on PharmaCompass.
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