X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
38
PharmaCompass offers a list of Sapropterin Hydrochloride 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 Sapropterin Hydrochloride manufacturer or Sapropterin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sapropterin Hydrochloride manufacturer or Sapropterin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Sapropterin Hydrochloride API Price utilized in the formulation of products. Sapropterin Hydrochloride API Price is not always fixed or binding as the Sapropterin Hydrochloride Price is obtained through a variety of data sources. The Sapropterin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A sapropterin 2HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sapropterin 2HCl, including repackagers and relabelers. The FDA regulates sapropterin 2HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sapropterin 2HCl 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 sapropterin 2HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A sapropterin 2HCl supplier is an individual or a company that provides sapropterin 2HCl active pharmaceutical ingredient (API) or sapropterin 2HCl finished formulations upon request. The sapropterin 2HCl suppliers may include sapropterin 2HCl API manufacturers, exporters, distributors and traders.
click here to find a list of sapropterin 2HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A sapropterin 2HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of sapropterin 2HCl active pharmaceutical ingredient (API) in detail. Different forms of sapropterin 2HCl DMFs exist exist since differing nations have different regulations, such as sapropterin 2HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sapropterin 2HCl DMF submitted to regulatory agencies in the US is known as a USDMF. sapropterin 2HCl USDMF includes data on sapropterin 2HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sapropterin 2HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of sapropterin 2HCl suppliers with USDMF on PharmaCompass.
A sapropterin 2HCl written confirmation (sapropterin 2HCl WC) is an official document issued by a regulatory agency to a sapropterin 2HCl manufacturer, verifying that the manufacturing facility of a sapropterin 2HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting sapropterin 2HCl APIs or sapropterin 2HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a sapropterin 2HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of sapropterin 2HCl 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 sapropterin 2HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for sapropterin 2HCl 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 sapropterin 2HCl 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 sapropterin 2HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a sapropterin 2HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of sapropterin 2HCl suppliers with NDC on PharmaCompass.
sapropterin 2HCl 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 sapropterin 2HCl 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 sapropterin 2HCl GMP manufacturer or sapropterin 2HCl GMP API supplier for your needs.
A sapropterin 2HCl CoA (Certificate of Analysis) is a formal document that attests to sapropterin 2HCl's compliance with sapropterin 2HCl specifications and serves as a tool for batch-level quality control.
sapropterin 2HCl CoA mostly includes findings from lab analyses of a specific batch. For each sapropterin 2HCl 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.
sapropterin 2HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (sapropterin 2HCl EP), sapropterin 2HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (sapropterin 2HCl USP).
Market Place
