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DRUG PRODUCT COMPOSITIONS0
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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- INJECTABLE;INJECTION - EQ 0.01MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ANALYTICAL
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 Cynomel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cynomel, including repackagers and relabelers. The FDA regulates Cynomel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cynomel 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 Cynomel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cynomel supplier is an individual or a company that provides Cynomel active pharmaceutical ingredient (API) or Cynomel finished formulations upon request. The Cynomel suppliers may include Cynomel API manufacturers, exporters, distributors and traders.
click here to find a list of Cynomel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cynomel DMF (Drug Master File) is a document detailing the whole manufacturing process of Cynomel active pharmaceutical ingredient (API) in detail. Different forms of Cynomel DMFs exist exist since differing nations have different regulations, such as Cynomel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cynomel DMF submitted to regulatory agencies in the US is known as a USDMF. Cynomel USDMF includes data on Cynomel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cynomel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cynomel 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 Cynomel Drug Master File in Japan (Cynomel JDMF) empowers Cynomel 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 Cynomel JDMF during the approval evaluation for pharmaceutical products. At the time of Cynomel 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 Cynomel 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 Cynomel Drug Master File in Korea (Cynomel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cynomel. The MFDS reviews the Cynomel KDMF as part of the drug registration process and uses the information provided in the Cynomel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cynomel 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 Cynomel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cynomel suppliers with KDMF on PharmaCompass.
A Cynomel CEP of the European Pharmacopoeia monograph is often referred to as a Cynomel Certificate of Suitability (COS). The purpose of a Cynomel CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cynomel EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cynomel to their clients by showing that a Cynomel CEP has been issued for it. The manufacturer submits a Cynomel CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cynomel CEP holder for the record. Additionally, the data presented in the Cynomel CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cynomel DMF.
A Cynomel CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cynomel 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 Cynomel suppliers with CEP (COS) on PharmaCompass.
A Cynomel written confirmation (Cynomel WC) is an official document issued by a regulatory agency to a Cynomel manufacturer, verifying that the manufacturing facility of a Cynomel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cynomel APIs or Cynomel finished pharmaceutical products to another nation, regulatory agencies frequently require a Cynomel WC (written confirmation) as part of the regulatory process.
click here to find a list of Cynomel 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 Cynomel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cynomel 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 Cynomel 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 Cynomel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cynomel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cynomel suppliers with NDC on PharmaCompass.
Cynomel 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 Cynomel 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 Cynomel GMP manufacturer or Cynomel GMP API supplier for your needs.
A Cynomel CoA (Certificate of Analysis) is a formal document that attests to Cynomel's compliance with Cynomel specifications and serves as a tool for batch-level quality control.
Cynomel CoA mostly includes findings from lab analyses of a specific batch. For each Cynomel 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.
Cynomel may be tested according to a variety of international standards, such as European Pharmacopoeia (Cynomel EP), Cynomel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cynomel USP).
