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API SUPPLIERS
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Drugs in Development
Lead Product(s) : Sapropterin Hydrochloride,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100mg, a therapeutic equivalent generic version of Kuvan® (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, is approved by the U.S. Food and Drug Administration (USFD...
Product Name : Sapropterin Dihydrochloride-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 07, 2021
Lead Product(s) : Sapropterin Hydrochloride,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The launch of generic version of Sapropterin Dihydrochloride Tablets, for Oral Use, illustrating the commitment to bring affordable generic medicines to market for patients. Dr. Reddy’s Sapropterin Dihydrochloride Tablets, 100 mg are available in bottl...
Product Name : Sapropterin Dihydrochloride-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 03, 2020
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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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sapropterin Hydrochloride, including repackagers and relabelers. The FDA regulates Sapropterin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sapropterin Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sapropterin Hydrochloride supplier is an individual or a company that provides Sapropterin Hydrochloride active pharmaceutical ingredient (API) or Sapropterin Hydrochloride finished formulations upon request. The Sapropterin Hydrochloride suppliers may include Sapropterin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sapropterin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sapropterin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sapropterin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sapropterin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sapropterin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sapropterin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sapropterin Hydrochloride USDMF includes data on Sapropterin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sapropterin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sapropterin Hydrochloride suppliers with USDMF on PharmaCompass.
A Sapropterin Hydrochloride written confirmation (Sapropterin Hydrochloride WC) is an official document issued by a regulatory agency to a Sapropterin Hydrochloride manufacturer, verifying that the manufacturing facility of a Sapropterin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sapropterin Hydrochloride APIs or Sapropterin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sapropterin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Sapropterin Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sapropterin Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sapropterin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sapropterin Hydrochloride suppliers with NDC on PharmaCompass.
Sapropterin Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Sapropterin Hydrochloride GMP API supplier for your needs.
A Sapropterin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sapropterin Hydrochloride's compliance with Sapropterin Hydrochloride specifications and serves as a tool for batch-level quality control.
Sapropterin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sapropterin Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sapropterin Hydrochloride EP), Sapropterin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sapropterin Hydrochloride USP).
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
