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PharmaCompass offers a list of DOTA 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 DOTA manufacturer or DOTA supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred DOTA manufacturer or DOTA supplier.
PharmaCompass also assists you with knowing the DOTA API Price utilized in the formulation of products. DOTA API Price is not always fixed or binding as the DOTA Price is obtained through a variety of data sources. The DOTA Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tetraxetan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tetraxetan, including repackagers and relabelers. The FDA regulates Tetraxetan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tetraxetan 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 Tetraxetan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tetraxetan supplier is an individual or a company that provides Tetraxetan active pharmaceutical ingredient (API) or Tetraxetan finished formulations upon request. The Tetraxetan suppliers may include Tetraxetan API manufacturers, exporters, distributors and traders.
click here to find a list of Tetraxetan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tetraxetan DMF (Drug Master File) is a document detailing the whole manufacturing process of Tetraxetan active pharmaceutical ingredient (API) in detail. Different forms of Tetraxetan DMFs exist exist since differing nations have different regulations, such as Tetraxetan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tetraxetan DMF submitted to regulatory agencies in the US is known as a USDMF. Tetraxetan USDMF includes data on Tetraxetan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tetraxetan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tetraxetan suppliers with USDMF 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 Tetraxetan Drug Master File in Korea (Tetraxetan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tetraxetan. The MFDS reviews the Tetraxetan KDMF as part of the drug registration process and uses the information provided in the Tetraxetan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tetraxetan 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 Tetraxetan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tetraxetan suppliers with KDMF on PharmaCompass.
Tetraxetan 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 Tetraxetan 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 Tetraxetan GMP manufacturer or Tetraxetan GMP API supplier for your needs.
A Tetraxetan CoA (Certificate of Analysis) is a formal document that attests to Tetraxetan's compliance with Tetraxetan specifications and serves as a tool for batch-level quality control.
Tetraxetan CoA mostly includes findings from lab analyses of a specific batch. For each Tetraxetan 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.
Tetraxetan may be tested according to a variety of international standards, such as European Pharmacopoeia (Tetraxetan EP), Tetraxetan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tetraxetan USP).