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ABOUT THIS PAGE
A Tertomotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tertomotide, including repackagers and relabelers. The FDA regulates Tertomotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tertomotide 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 Tertomotide supplier is an individual or a company that provides Tertomotide active pharmaceutical ingredient (API) or Tertomotide finished formulations upon request. The Tertomotide suppliers may include Tertomotide API manufacturers, exporters, distributors and traders.
click here to find a list of Tertomotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tertomotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Tertomotide active pharmaceutical ingredient (API) in detail. Different forms of Tertomotide DMFs exist exist since differing nations have different regulations, such as Tertomotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tertomotide DMF submitted to regulatory agencies in the US is known as a USDMF. Tertomotide USDMF includes data on Tertomotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tertomotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tertomotide 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 Tertomotide Drug Master File in Korea (Tertomotide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tertomotide. The MFDS reviews the Tertomotide KDMF as part of the drug registration process and uses the information provided in the Tertomotide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tertomotide 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 Tertomotide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tertomotide suppliers with KDMF on PharmaCompass.
Tertomotide 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 Tertomotide 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 Tertomotide GMP manufacturer or Tertomotide GMP API supplier for your needs.
A Tertomotide CoA (Certificate of Analysis) is a formal document that attests to Tertomotide's compliance with Tertomotide specifications and serves as a tool for batch-level quality control.
Tertomotide CoA mostly includes findings from lab analyses of a specific batch. For each Tertomotide 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.
Tertomotide may be tested according to a variety of international standards, such as European Pharmacopoeia (Tertomotide EP), Tertomotide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tertomotide USP).
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