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PharmaCompass offers a list of Teduglutide 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 Teduglutide manufacturer or Teduglutide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Teduglutide manufacturer or Teduglutide supplier.
PharmaCompass also assists you with knowing the Teduglutide API Price utilized in the formulation of products. Teduglutide API Price is not always fixed or binding as the Teduglutide Price is obtained through a variety of data sources. The Teduglutide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A GATTEX KIT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GATTEX KIT, including repackagers and relabelers. The FDA regulates GATTEX KIT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GATTEX KIT 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 GATTEX KIT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A GATTEX KIT supplier is an individual or a company that provides GATTEX KIT active pharmaceutical ingredient (API) or GATTEX KIT finished formulations upon request. The GATTEX KIT suppliers may include GATTEX KIT API manufacturers, exporters, distributors and traders.
click here to find a list of GATTEX KIT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A GATTEX KIT DMF (Drug Master File) is a document detailing the whole manufacturing process of GATTEX KIT active pharmaceutical ingredient (API) in detail. Different forms of GATTEX KIT DMFs exist exist since differing nations have different regulations, such as GATTEX KIT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A GATTEX KIT DMF submitted to regulatory agencies in the US is known as a USDMF. GATTEX KIT USDMF includes data on GATTEX KIT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The GATTEX KIT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of GATTEX KIT suppliers with USDMF on PharmaCompass.
A GATTEX KIT written confirmation (GATTEX KIT WC) is an official document issued by a regulatory agency to a GATTEX KIT manufacturer, verifying that the manufacturing facility of a GATTEX KIT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting GATTEX KIT APIs or GATTEX KIT finished pharmaceutical products to another nation, regulatory agencies frequently require a GATTEX KIT WC (written confirmation) as part of the regulatory process.
click here to find a list of GATTEX KIT 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 GATTEX KIT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for GATTEX KIT 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 GATTEX KIT 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 GATTEX KIT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a GATTEX KIT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of GATTEX KIT suppliers with NDC on PharmaCompass.
GATTEX KIT 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 GATTEX KIT 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 GATTEX KIT GMP manufacturer or GATTEX KIT GMP API supplier for your needs.
A GATTEX KIT CoA (Certificate of Analysis) is a formal document that attests to GATTEX KIT's compliance with GATTEX KIT specifications and serves as a tool for batch-level quality control.
GATTEX KIT CoA mostly includes findings from lab analyses of a specific batch. For each GATTEX KIT 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.
GATTEX KIT may be tested according to a variety of international standards, such as European Pharmacopoeia (GATTEX KIT EP), GATTEX KIT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (GATTEX KIT USP).
