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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
About the Company : Vtides Life Sciences Pvt Ltd specializes in the design and synthesis of complex peptides, employing advanced chemical strategies such as microwave-assisted solid-phase synthesis. T...
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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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gattex, including repackagers and relabelers. The FDA regulates Gattex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gattex 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gattex supplier is an individual or a company that provides Gattex active pharmaceutical ingredient (API) or Gattex finished formulations upon request. The Gattex suppliers may include Gattex API manufacturers, exporters, distributors and traders.
click here to find a list of Gattex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gattex DMF (Drug Master File) is a document detailing the whole manufacturing process of Gattex active pharmaceutical ingredient (API) in detail. Different forms of Gattex DMFs exist exist since differing nations have different regulations, such as Gattex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gattex DMF submitted to regulatory agencies in the US is known as a USDMF. Gattex USDMF includes data on Gattex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gattex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gattex suppliers with USDMF 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gattex 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gattex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gattex suppliers with NDC on PharmaCompass.
Gattex 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 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 GMP manufacturer or Gattex GMP API supplier for your needs.
A Gattex CoA (Certificate of Analysis) is a formal document that attests to Gattex's compliance with Gattex specifications and serves as a tool for batch-level quality control.
Gattex CoA mostly includes findings from lab analyses of a specific batch. For each Gattex 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Gattex EP), Gattex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gattex USP).
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