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API SUPPLIERS
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USDMF
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API Imports and Exports
ABOUT THIS PAGE
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PharmaCompass offers a list of TATM 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 TATM manufacturer or TATM supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred TATM manufacturer or TATM supplier.
PharmaCompass also assists you with knowing the TATM API Price utilized in the formulation of products. TATM API Price is not always fixed or binding as the TATM Price is obtained through a variety of data sources. The TATM Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TATM manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TATM, including repackagers and relabelers. The FDA regulates TATM manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TATM API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A TATM supplier is an individual or a company that provides TATM active pharmaceutical ingredient (API) or TATM finished formulations upon request. The TATM suppliers may include TATM API manufacturers, exporters, distributors and traders.
click here to find a list of TATM suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TATM DMF (Drug Master File) is a document detailing the whole manufacturing process of TATM active pharmaceutical ingredient (API) in detail. Different forms of TATM DMFs exist exist since differing nations have different regulations, such as TATM USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TATM DMF submitted to regulatory agencies in the US is known as a USDMF. TATM USDMF includes data on TATM's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TATM USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TATM suppliers with USDMF on PharmaCompass.
A TATM CEP of the European Pharmacopoeia monograph is often referred to as a TATM Certificate of Suitability (COS). The purpose of a TATM CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TATM EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TATM to their clients by showing that a TATM CEP has been issued for it. The manufacturer submits a TATM CEP (COS) as part of the market authorization procedure, and it takes on the role of a TATM CEP holder for the record. Additionally, the data presented in the TATM CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TATM DMF.
A TATM CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TATM 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 TATM suppliers with CEP (COS) 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 TATM as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TATM 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 TATM 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 TATM and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TATM NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TATM suppliers with NDC on PharmaCompass.
TATM 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 TATM 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 TATM GMP manufacturer or TATM GMP API supplier for your needs.
A TATM CoA (Certificate of Analysis) is a formal document that attests to TATM's compliance with TATM specifications and serves as a tool for batch-level quality control.
TATM CoA mostly includes findings from lab analyses of a specific batch. For each TATM 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.
TATM may be tested according to a variety of international standards, such as European Pharmacopoeia (TATM EP), TATM JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TATM USP).
