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South Africa
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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Maithri Drugs: Dedicated to your API needs.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-18
Pay. Date : 2021-09-28
DMF Number : 36147
Submission : 2021-07-31
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-20
Pay. Date : 2019-07-26
DMF Number : 33928
Submission : 2019-08-06
Status :
Type : II
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : Complete
Rev. Date : 2025-11-13
Pay. Date : 2025-09-30
DMF Number : 41077
Submission : 2024-12-31
Status :
Type : II
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Sapropterin Dihydrochloride IH/USP
Date of Issue : 2025-02-27
Valid Till : 2028-02-26
Written Confirmation Number : WC-511n
Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Sapropterin Hydrochloride IH/USP
Date of Issue : 2025-02-27
Valid Till : 2028-02-26
Written Confirmation Number : WC-0511
Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Sapropterin dihydrochloride IH
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
Maithri Drugs: Dedicated to your API needs.
Sapropterin Dihydrochloride IH
Date of Issue : 2024-02-12
Valid Till : 2027-02-11
Written Confirmation Number : WC-0407
Address of the Firm : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Ma...
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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.
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, and COA 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, and COA 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, 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).
