US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Somatropin 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 Somatropin manufacturer or Somatropin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Somatropin manufacturer or Somatropin supplier.
PharmaCompass also assists you with knowing the Somatropin API Price utilized in the formulation of products. Somatropin API Price is not always fixed or binding as the Somatropin Price is obtained through a variety of data sources. The Somatropin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Somatropin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Somatropin, including repackagers and relabelers. The FDA regulates Somatropin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Somatropin 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 Somatropin supplier is an individual or a company that provides Somatropin active pharmaceutical ingredient (API) or Somatropin finished formulations upon request. The Somatropin suppliers may include Somatropin API manufacturers, exporters, distributors and traders.
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 Somatropin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Somatropin 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 Somatropin 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 Somatropin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Somatropin NDC to their finished compounded human drug products, they may choose to do so.
CLICK HERE to find a list of Somatropin suppliers with NDC on PharmaCompass.
Somatropin 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 Somatropin 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 Somatropin GMP manufacturer or Somatropin GMP API supplier for your needs.
A Somatropin CoA (Certificate of Analysis) is a formal document that attests to Somatropin's compliance with Somatropin specifications and serves as a tool for batch-level quality control.
Somatropin CoA mostly includes findings from lab analyses of a specific batch. For each Somatropin 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.
Somatropin may be tested according to a variety of international standards, such as European Pharmacopoeia (Somatropin EP), Somatropin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Somatropin USP).