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