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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
About the Company : Bioiberica is a global Life Science company with more than 45 years' experience in the production and development of molecules of high biological and therapeutic value for the phar...
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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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ABOUT THIS PAGE
24
PharmaCompass offers a list of Levothyroxine Sodium 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 Levothyroxine Sodium manufacturer or Levothyroxine Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levothyroxine Sodium manufacturer or Levothyroxine Sodium supplier.
PharmaCompass also assists you with knowing the Levothyroxine Sodium API Price utilized in the formulation of products. Levothyroxine Sodium API Price is not always fixed or binding as the Levothyroxine Sodium Price is obtained through a variety of data sources. The Levothyroxine Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
A Levothyroxine DMF (Drug Master File) is a document detailing the whole manufacturing process of Levothyroxine active pharmaceutical ingredient (API) in detail. Different forms of Levothyroxine DMFs exist exist since differing nations have different regulations, such as Levothyroxine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levothyroxine DMF submitted to regulatory agencies in the US is known as a USDMF. Levothyroxine USDMF includes data on Levothyroxine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levothyroxine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levothyroxine 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 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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Levothyroxine Drug Master File in Korea (Levothyroxine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levothyroxine. The MFDS reviews the Levothyroxine KDMF as part of the drug registration process and uses the information provided in the Levothyroxine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Levothyroxine 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 Levothyroxine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Levothyroxine suppliers with KDMF on PharmaCompass.
A Levothyroxine CEP of the European Pharmacopoeia monograph is often referred to as a Levothyroxine Certificate of Suitability (COS). The purpose of a Levothyroxine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levothyroxine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levothyroxine to their clients by showing that a Levothyroxine CEP has been issued for it. The manufacturer submits a Levothyroxine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levothyroxine CEP holder for the record. Additionally, the data presented in the Levothyroxine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levothyroxine DMF.
A Levothyroxine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levothyroxine 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 Levothyroxine suppliers with CEP (COS) on PharmaCompass.
A Levothyroxine written confirmation (Levothyroxine WC) is an official document issued by a regulatory agency to a Levothyroxine manufacturer, verifying that the manufacturing facility of a Levothyroxine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levothyroxine APIs or Levothyroxine finished pharmaceutical products to another nation, regulatory agencies frequently require a Levothyroxine WC (written confirmation) as part of the regulatory process.
click here to find a list of Levothyroxine 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 Levothyroxine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levothyroxine 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 Levothyroxine 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 Levothyroxine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levothyroxine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levothyroxine suppliers with NDC on PharmaCompass.
Levothyroxine 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 Levothyroxine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Levothyroxine GMP manufacturer or Levothyroxine GMP API supplier for your needs.
A Levothyroxine CoA (Certificate of Analysis) is a formal document that attests to Levothyroxine's compliance with Levothyroxine specifications and serves as a tool for batch-level quality control.
Levothyroxine CoA mostly includes findings from lab analyses of a specific batch. For each Levothyroxine 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.
Levothyroxine may be tested according to a variety of international standards, such as European Pharmacopoeia (Levothyroxine EP), Levothyroxine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levothyroxine USP).
