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