Find Sapropterin Hydrochloride manufacturers, exporters & distributors on PharmaCompass

Sapropterin Dihydrochloride

Biophore Sapropterin HCl

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2025-01-20

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 8 USDMF, 9 NDC API, 6 Listed Suppliers, $ API Reference Price

12 API Suppliers
8 USDMF
9 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

49 FDF Dossiers, 12 FDA Orange Book, 20 Europe, 5 Canada, 11 Australia, 1 Listed Dossiers

49 FDF Dossiers
12 FDA Orange Book
20 Europe
5 Canada
11 Australia
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 13 SPI Pharma, 1 Pharm-RX Chemical, 2 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 2 Gangwal Healthcare, 1 Pfanstiehl, 2 Alcedo Pharmachem, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 Bioplus Life Sciences, 5 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 3 Microlex e.U, 1 NEWEDGE Overseas, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Prachin Chemical, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders, 17 Disintegrants & Superdisintegrants, 17 Direct Compression, 14 Chewable & Orodispersible Aids, 11 Taste Masking, 7 Granulation, 6 Lubricants & Glidants, 5 Thickeners and Stabilizers, 4 Parenteral, 4 Co-Processed Excipients, 3 Solubilizers, 2 Coating Systems & Additives, 1 API Stability Enhancers, 1 Film Formers & Plasticizers

excipientsByApplications
21 Fillers, Diluents & Binders
17 Disintegrants & Superdisintegrants
17 Direct Compression
14 Chewable & Orodispersible Aids
11 Taste Masking
7 Granulation
6 Lubricants & Glidants
5 Thickeners and Stabilizers
4 Parenteral
4 Co-Processed Excipients
3 Solubilizers
2 Coating Systems & Additives
1 API Stability Enhancers
1 Film Formers & Plasticizers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 34 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
34 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 19 Finished Drug Prices, 7 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
19 Finished Drug Prices
7 Annual Reports

MARKET PLACE

15 APIs, 1 FDF Dossiers, 1 Intermediates

marketPlace
15 APIs
1 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

42 US Patents, 4 Health Canada Patents

patents
42 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

8 Others

otherSolutions
8 Others

Sapropterin HCl

Synopsis

ACTIVE PHARMA INGREDIENTS

12

API Suppliers

8

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

0

EU WC

0

KDMF

9

NDC API

0

VMF

6

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 16,686

MARKET PLACE

15

API

1

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

49

FDF Dossiers

12

FDA Orange Book

FDA (Orange Book)

20

Europe

5

Canada

11

Australia

0

South Africa

1

Listed Dossiers

4DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

8

Others

PATENTS & EXCLUSIVITIES

42

US Patents

0

US Exclusivities

4

Health Canada Patents

DIGITAL CONTENT

1

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

34

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

25,936,530

Annual Reports (USD Million)

2,458

Finished Drug Prices

63 RELATED EXCIPIENT COMPANIES

113EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

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Also known as:

Molecular Formula

C₉H₁₇Cl₂N₅O₃

Molecular Weight

314.17 g/mol

InChI Key

RKSUYBCOVNCALL-NTVURLEBSA-N

Sapropterin Hydrochloride

1 2D Structure

Sapropterin Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one;dihydrochloride

2.1.2 InChI

InChI=1S/C9H15N5O3.2ClH/c1-3(15)6(16)4-2-11-7-5(12-4)8(17)14-9(10)13-7;;/h3-4,6,12,15-16H,2H2,1H3,(H4,10,11,13,14,17);2*1H/t3-,4+,6-;;/m0../s1

2.1.3 InChI Key

RKSUYBCOVNCALL-NTVURLEBSA-N

2.1.4 Canonical SMILES

CC(C(C1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl

2.1.5 Isomeric SMILES

C[C@@H]([C@@H]([C@H]1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl

2.2 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₉H₁₇Cl₂N₅O₃
Molecular Weight	314.17 g/mol
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 SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Contact Supplier

India

Digital Content

USDMF

Click Us!

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

Product Web Link

Digital Content

02

Solara Active Pharma Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

03

HONOUR LAB LTD

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

04

Asymchem Laboratories

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

05

Innopharmax

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

06

Dipharma SA

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

07

Dipharma

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

08

Shiratori Pharmaceutical

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

09

Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

10

Seven Star Pharmaceutical

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

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USDMF

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NDC API

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Listed Suppliers

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API Reference Price

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Number of Transactions

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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

Sapropterin Dihydrochloride Manufacturers

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.

Sapropterin Dihydrochloride Suppliers

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.

Sapropterin Dihydrochloride USDMF

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.

Sapropterin Dihydrochloride NDC

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).

Finished drug products

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.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Sapropterin Dihydrochloride CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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