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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2013-09-26
DMF Number : 24402
Submission : 2011-10-20
Status :
Type : II
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Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
Certificate Number : CEP 2011-315 - Rev 02
Status : Valid
Issue Date : 2023-11-08
Type : Chemical
Substance Number : 401
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 0.0125MG;0.0031MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - TABLET;ORAL - 0.025MG;0.0063MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - TABLET;ORAL - 0.05MG;0.0125MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - TABLET;ORAL - 0.15MG;0.0375MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - TABLET;ORAL - 0.1MG;0.025MG
USFDA APPLICATION NUMBER - 16807
DOSAGE - POWDER;INTRAVENOUS - 100MCG/VIAL
USFDA APPLICATION NUMBER - 202231
DOSAGE - POWDER;INTRAVENOUS - 200MCG/VIAL
USFDA APPLICATION NUMBER - 202231
DOSAGE - POWDER;INTRAVENOUS - 500MCG/VIAL
USFDA APPLICATION NUMBER - 202231
DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21116
DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21210
DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
USFDA APPLICATION NUMBER - 21402
DOSAGE - CAPSULE;ORAL - 0.013MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.025MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.0375MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.044MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.05MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.0625MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.075MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.088MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.112MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.125MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.137MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.15MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.175MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.1MG
USFDA APPLICATION NUMBER - 21924
DOSAGE - CAPSULE;ORAL - 0.2MG
USFDA APPLICATION NUMBER - 21924
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
55
PharmaCompass offers a list of Thyroxine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Thyroxine manufacturer or Thyroxine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Thyroxine manufacturer or Thyroxine supplier.
A Synthrox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Synthrox, including repackagers and relabelers. The FDA regulates Synthrox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Synthrox 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 Synthrox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Synthrox supplier is an individual or a company that provides Synthrox active pharmaceutical ingredient (API) or Synthrox finished formulations upon request. The Synthrox suppliers may include Synthrox API manufacturers, exporters, distributors and traders.
click here to find a list of Synthrox suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Synthrox DMF (Drug Master File) is a document detailing the whole manufacturing process of Synthrox active pharmaceutical ingredient (API) in detail. Different forms of Synthrox DMFs exist exist since differing nations have different regulations, such as Synthrox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Synthrox DMF submitted to regulatory agencies in the US is known as a USDMF. Synthrox USDMF includes data on Synthrox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Synthrox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Synthrox suppliers with USDMF 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 Synthrox Drug Master File in Japan (Synthrox JDMF) empowers Synthrox 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 Synthrox JDMF during the approval evaluation for pharmaceutical products. At the time of Synthrox 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 Synthrox suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Synthrox Drug Master File in Korea (Synthrox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Synthrox. The MFDS reviews the Synthrox KDMF as part of the drug registration process and uses the information provided in the Synthrox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Synthrox KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Synthrox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Synthrox suppliers with KDMF on PharmaCompass.
A Synthrox CEP of the European Pharmacopoeia monograph is often referred to as a Synthrox Certificate of Suitability (COS). The purpose of a Synthrox CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Synthrox EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Synthrox to their clients by showing that a Synthrox CEP has been issued for it. The manufacturer submits a Synthrox CEP (COS) as part of the market authorization procedure, and it takes on the role of a Synthrox CEP holder for the record. Additionally, the data presented in the Synthrox CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Synthrox DMF.
A Synthrox CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Synthrox CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Synthrox suppliers with CEP (COS) on PharmaCompass.
A Synthrox written confirmation (Synthrox WC) is an official document issued by a regulatory agency to a Synthrox manufacturer, verifying that the manufacturing facility of a Synthrox active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Synthrox APIs or Synthrox finished pharmaceutical products to another nation, regulatory agencies frequently require a Synthrox WC (written confirmation) as part of the regulatory process.
click here to find a list of Synthrox suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Synthrox as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Synthrox API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Synthrox as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Synthrox and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Synthrox NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Synthrox suppliers with NDC on PharmaCompass.
Synthrox Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Synthrox GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Synthrox GMP manufacturer or Synthrox GMP API supplier for your needs.
A Synthrox CoA (Certificate of Analysis) is a formal document that attests to Synthrox's compliance with Synthrox specifications and serves as a tool for batch-level quality control.
Synthrox CoA mostly includes findings from lab analyses of a specific batch. For each Synthrox CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Synthrox may be tested according to a variety of international standards, such as European Pharmacopoeia (Synthrox EP), Synthrox JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Synthrox USP).
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