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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - EQ 0.005MG BASE
USFDA APPLICATION NUMBER - 10379
DOSAGE - TABLET;ORAL - EQ 0.025MG BASE
USFDA APPLICATION NUMBER - 10379
DOSAGE - TABLET;ORAL - EQ 0.05MG BASE
USFDA APPLICATION NUMBER - 10379
DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20105
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
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PharmaCompass offers a list of Liothyronine 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 Liothyronine Sodium manufacturer or Liothyronine Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Liothyronine Sodium manufacturer or Liothyronine Sodium supplier.
PharmaCompass also assists you with knowing the Liothyronine Sodium API Price utilized in the formulation of products. Liothyronine Sodium API Price is not always fixed or binding as the Liothyronine Sodium Price is obtained through a variety of data sources. The Liothyronine Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Liothyronine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Liothyronine, including repackagers and relabelers. The FDA regulates Liothyronine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Liothyronine 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 Liothyronine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Liothyronine supplier is an individual or a company that provides Liothyronine active pharmaceutical ingredient (API) or Liothyronine finished formulations upon request. The Liothyronine suppliers may include Liothyronine API manufacturers, exporters, distributors and traders.
click here to find a list of Liothyronine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Liothyronine DMF (Drug Master File) is a document detailing the whole manufacturing process of Liothyronine active pharmaceutical ingredient (API) in detail. Different forms of Liothyronine DMFs exist exist since differing nations have different regulations, such as Liothyronine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Liothyronine DMF submitted to regulatory agencies in the US is known as a USDMF. Liothyronine USDMF includes data on Liothyronine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Liothyronine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Liothyronine 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 Liothyronine Drug Master File in Japan (Liothyronine JDMF) empowers Liothyronine 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 Liothyronine JDMF during the approval evaluation for pharmaceutical products. At the time of Liothyronine 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 Liothyronine 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 Liothyronine Drug Master File in Korea (Liothyronine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Liothyronine. The MFDS reviews the Liothyronine KDMF as part of the drug registration process and uses the information provided in the Liothyronine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Liothyronine 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 Liothyronine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Liothyronine suppliers with KDMF on PharmaCompass.
A Liothyronine CEP of the European Pharmacopoeia monograph is often referred to as a Liothyronine Certificate of Suitability (COS). The purpose of a Liothyronine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Liothyronine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Liothyronine to their clients by showing that a Liothyronine CEP has been issued for it. The manufacturer submits a Liothyronine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Liothyronine CEP holder for the record. Additionally, the data presented in the Liothyronine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Liothyronine DMF.
A Liothyronine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Liothyronine 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 Liothyronine suppliers with CEP (COS) on PharmaCompass.
A Liothyronine written confirmation (Liothyronine WC) is an official document issued by a regulatory agency to a Liothyronine manufacturer, verifying that the manufacturing facility of a Liothyronine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Liothyronine APIs or Liothyronine finished pharmaceutical products to another nation, regulatory agencies frequently require a Liothyronine WC (written confirmation) as part of the regulatory process.
click here to find a list of Liothyronine 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 Liothyronine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Liothyronine 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 Liothyronine 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 Liothyronine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Liothyronine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Liothyronine suppliers with NDC on PharmaCompass.
Liothyronine 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 Liothyronine 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 Liothyronine GMP manufacturer or Liothyronine GMP API supplier for your needs.
A Liothyronine CoA (Certificate of Analysis) is a formal document that attests to Liothyronine's compliance with Liothyronine specifications and serves as a tool for batch-level quality control.
Liothyronine CoA mostly includes findings from lab analyses of a specific batch. For each Liothyronine 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.
Liothyronine may be tested according to a variety of international standards, such as European Pharmacopoeia (Liothyronine EP), Liothyronine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Liothyronine USP).
