Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
Molecular Weight | 314.17 g/mol |
---|---|
Molecular Formula | C9H17Cl2N5O3 |
Hydrogen Bond Donor Count | 8 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 2 |
Exact Mass | 313.0708448 g/mol |
Monoisotopic Mass | 313.0708448 g/mol |
Topological Polar Surface Area | 132 A^2 |
Heavy Atom Count | 19 |
Formal Charge | 0 |
Complexity | 405 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
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 (USFDA).
Lead Product(s): Sapropterin Hydrochloride,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Sapropterin Dihydrochloride-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: 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 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
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 bottle count sizes of 120.
Lead Product(s): Sapropterin Hydrochloride,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Sapropterin Dihydrochloride-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 03, 2020
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
Details:
RLF-OD032 is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Lead Product(s): RLF-OD032,Sapropterin Hydrochloride
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 23, 2025
Lead Product(s) : RLF-OD032,Sapropterin Hydrochloride
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed
Details : RLF-OD032 is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 23, 2025
Details:
RLF-OD032 (sapropterin dihydrochloride) is a PAH agonist small molecule drug candidate which is being evaluated for the treatment of phenylketonuria.
Lead Product(s): Sapropterin Hydrochloride,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 04, 2024
Lead Product(s) : Sapropterin Hydrochloride,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Relief Therapeutics Reports Positive Results from RLF-OD032 Study For Phenylketonuria
Details : RLF-OD032 (sapropterin dihydrochloride) is a PAH agonist small molecule drug candidate which is being evaluated for the treatment of phenylketonuria.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 04, 2024
Details:
RLF-OD032, an innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, is designed to lower blood phenylalanine in adult and pediatric PKU patients.
Lead Product(s): Sapropterin Hydrochloride,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 18, 2024
Lead Product(s) : Sapropterin Hydrochloride,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Relief Completes Phase in RLF-OD032 Study; Topline Results Expected October 2024
Details : RLF-OD032, an innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, is designed to lower blood phenylalanine in adult and pediatric PKU patients.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 18, 2024
Details:
RLF-OD032 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): RLF-OD032,Sapropterin Hydrochloride
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 01, 2024
Lead Product(s) : RLF-OD032,Sapropterin Hydrochloride
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
Details : RLF-OD032 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 01, 2024
Details:
Sapropterin Dihydrochloride is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.
Lead Product(s): Sapropterin Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Innovent Biologics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 02, 2024
Lead Product(s) : Sapropterin Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Innovent Biologics
Deal Size : Inapplicable
Deal Type : Inapplicable
PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC
Details : Sapropterin Dihydrochloride is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 02, 2024
Details:
Tetrahydrobiopterin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Intermittent Claudication.
Lead Product(s): Sapropterin Hydrochloride,Ascorbic Acid,L-Arginine
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: BioMarin Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 16, 2021
Lead Product(s) : Sapropterin Hydrochloride,Ascorbic Acid,L-Arginine
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : BioMarin Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Tetrahydrobiopterin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Intermittent Claudication.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 16, 2021
Details:
Sapropterin Dihydrochloride is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Phenylketonurias.
Lead Product(s): Sapropterin Hydrochloride,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: BioMarin Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 09, 2016
Lead Product(s) : Sapropterin Hydrochloride,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : BioMarin Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
The Effectiveness of Kuvan in Amish PKU Patients
Details : Sapropterin Dihydrochloride is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Phenylketonurias.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 09, 2016
Details:
Kuvan (Sapropterin Dihydrochloride) is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Heart Failure.
Lead Product(s): Sapropterin Hydrochloride,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Kuvan
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: BioMarin Pharmaceutical | Lifespan
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 02, 2015
Lead Product(s) : Sapropterin Hydrochloride,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : BioMarin Pharmaceutical | Lifespan
Deal Size : Inapplicable
Deal Type : Inapplicable
Rhode Island Diastolic Dysfunction - Heart Failure
Details : Kuvan (Sapropterin Dihydrochloride) is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Heart Failure.
Product Name : Kuvan
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 02, 2015
Regulatory Info :
Registration Country : Italy
Brand Name : SAPROPTERINA AUROBINDO
Dosage Form : Soluble Tablets
Dosage Strength : 100 mg
Packaging : 120 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : SAPROPTERIN DIPHARMA
Dosage Form : Soluble Tablets
Dosage Strength : 100mg
Packaging : 30 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Sapropterin Dipharma
Dosage Form : Soluble tablet
Dosage Strength : 100 mg
Packaging : Bottle 120item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sapropterin Dipharma
Dosage Form : Powder For Oral Solution
Dosage Strength : 500mg
Packaging :
Approval Date : 16/02/2022
Application Number : 20201228000085
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sapropterina Dipharma
Dosage Form : Powder For Oral Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2022-12-22
Application Number : 1211620003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Sapropterin Dipharma
Dosage Form : Powder For Oral Solution
Dosage Strength : 100mg
Packaging :
Approval Date : 14/12/2021
Application Number : 67735
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : ARPETRAN
Dosage Form : Soluble Tablets
Dosage Strength : 100 mg
Packaging : 120 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Sapropterin Spirig HC
Dosage Form : Tablet For Oral Solution
Dosage Strength : 100mg
Packaging :
Approval Date : 18/10/2024
Application Number : 69871
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : The Cow
Dosage Form : Powder For Oral Solution
Dosage Strength : 100mg
Packaging :
Approval Date : 13/07/2017
Application Number : 20161109000071
Regulatory Info : Approved
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sapropterina Tarbis
Dosage Form : Soluble Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 2024-09-30
Application Number : 89850
Regulatory Info : Authorized
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Related Excipient Companies
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
48
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 Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sapropterin Dihydrochloride, including repackagers and relabelers. The FDA regulates Sapropterin Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sapropterin Dihydrochloride 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 Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sapropterin Dihydrochloride supplier is an individual or a company that provides Sapropterin Dihydrochloride active pharmaceutical ingredient (API) or Sapropterin Dihydrochloride finished formulations upon request. The Sapropterin Dihydrochloride suppliers may include Sapropterin Dihydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sapropterin Dihydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sapropterin Dihydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sapropterin Dihydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sapropterin Dihydrochloride DMFs exist exist since differing nations have different regulations, such as Sapropterin Dihydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sapropterin Dihydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sapropterin Dihydrochloride USDMF includes data on Sapropterin Dihydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sapropterin Dihydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sapropterin Dihydrochloride suppliers with USDMF on PharmaCompass.
A Sapropterin Dihydrochloride written confirmation (Sapropterin Dihydrochloride WC) is an official document issued by a regulatory agency to a Sapropterin Dihydrochloride manufacturer, verifying that the manufacturing facility of a Sapropterin Dihydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sapropterin Dihydrochloride APIs or Sapropterin Dihydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sapropterin Dihydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Sapropterin Dihydrochloride 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 Dihydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sapropterin Dihydrochloride 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 Dihydrochloride 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 Dihydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sapropterin Dihydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sapropterin Dihydrochloride suppliers with NDC on PharmaCompass.
Sapropterin Dihydrochloride 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 Dihydrochloride 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 Dihydrochloride GMP manufacturer or Sapropterin Dihydrochloride GMP API supplier for your needs.
A Sapropterin Dihydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sapropterin Dihydrochloride's compliance with Sapropterin Dihydrochloride specifications and serves as a tool for batch-level quality control.
Sapropterin Dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sapropterin Dihydrochloride 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 Dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sapropterin Dihydrochloride EP), Sapropterin Dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sapropterin Dihydrochloride USP).