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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

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DRUG PRODUCT COMPOSITIONS

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PATENTS & EXCLUSIVITIES

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Health Canada Patents

API REF. PRICE (USD/KG)

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GLOBAL SALES INFORMATION

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API

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Chemistry

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Also known as: Ag-348 sulfate hydrate, Mitapivat sulfate [usan], N4jta67v3o, Pyrukynd, Ag-348 hemisulfate sesquihydrate, Mitapivat sulfate (usan)
Molecular Formula
C48H60N8O13S3
Molecular Weight
1053.2  g/mol
InChI Key
DMRIPASJCJRBMV-UHFFFAOYSA-N
FDA UNII
N4JTA67V3O

Mitapivat
1 2D Structure

Mitapivat

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[4-[4-(cyclopropylmethyl)piperazine-1-carbonyl]phenyl]quinoline-8-sulfonamide;sulfuric acid;trihydrate
2.1.2 InChI
InChI=1S/2C24H26N4O3S.H2O4S.3H2O/c2*29-24(28-15-13-27(14-16-28)17-18-6-7-18)20-8-10-21(11-9-20)26-32(30,31)22-5-1-3-19-4-2-12-25-23(19)22;1-5(2,3)4;;;/h2*1-5,8-12,18,26H,6-7,13-17H2;(H2,1,2,3,4);3*1H2
2.1.3 InChI Key
DMRIPASJCJRBMV-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CC1CN2CCN(CC2)C(=O)C3=CC=C(C=C3)NS(=O)(=O)C4=CC=CC5=C4N=CC=C5.C1CC1CN2CCN(CC2)C(=O)C3=CC=C(C=C3)NS(=O)(=O)C4=CC=CC5=C4N=CC=C5.O.O.O.OS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
N4JTA67V3O
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 8-quinolinesulfonamide, N-(4-((4-(cyclopropylmethyl)-1-piperazinyl)carbonyl)phenyl)-

2. Ag-348

3. Mitapivat

4. Mitapivat Hemisulfate Sesquihydrate

5. N-(4-((4-(cyclopropylmethyl)-1-piperazinyl)carbonyl)phenyl)-8-quinolinesulfonamide

6. N-(4-(4-(cyclopropylmethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide

7. Pyrukynd

2.3.2 Depositor-Supplied Synonyms

1. Ag-348 Sulfate Hydrate

2. Mitapivat Sulfate [usan]

3. N4jta67v3o

4. Pyrukynd

5. Ag-348 Hemisulfate Sesquihydrate

6. Mitapivat Sulfate (usan)

7. 2151847-10-6

8. 8-quinolinesulfonamide, N-(4-((4-(cyclopropylmethyl)-1-piperazinyl)carbonyl)phenyl)-, Sulfate, Hydrate (2:1:3)

9. N-(4-(4-(cyclopropylmethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide Sulfate Hydrate (2:1:3)

10. Unii-n4jta67v3o

11. Chembl4297223

12. Mitapivat Hemisulfate Sesquihydrate

13. D11408

2.4 Create Date
2018-08-12
3 Chemical and Physical Properties
Molecular Weight 1053.2 g/mol
Molecular Formula C48H60N8O13S3
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count19
Rotatable Bond Count12
Exact Mass1052.34419752 g/mol
Monoisotopic Mass1052.34419752 g/mol
Topological Polar Surface Area268 Ų
Heavy Atom Count72
Formal Charge0
Complexity831
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count6
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Enzyme Activators

Compounds or factors that act on a specific enzyme to increase its activity. (See all compounds classified as Enzyme Activators.)


API SUPPLIERS

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01

Nuray Chemicals Private Limited

India

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Nuray Chemicals

02

Maithri Drugs

India

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

PEGS Boston Summit
Not Confirmed
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Maithri Drugs

India

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

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USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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03

SMS Pharmaceuticals

India

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

PEGS Boston Summit
Not Confirmed
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04

Apicore

India

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

PEGS Boston Summit
Not Confirmed
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05

Synthimed Labs

India

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

PEGS Boston Summit
Not Confirmed
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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Digital Content Digital Content

Mitapivat

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
Nuray Chemicals

02

Apicore

India
PEGS Boston Summit
Not Confirmed
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Apicore

India
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Not Confirmed

Mitapivat

About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...

Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide portfolio of services ranging from API’s for the generic industry to custom synthesis for early phase pharmaceutical research and branded products. Our USFDA approved facilities in India (Visakhapatnam, Andhra Pradesh and Vadodara, Gujarat) are both equipped with state-of-the-art analytical and research capabilities. While our worldwide network of locations seamlessly integrate with each other, each unit also independently houses a full
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03

PEGS Boston Summit
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Mitapivat

About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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04

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Mitapivat

About the Company : SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a sin...

SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a single facility - single product manufacturing company in 1990 grew to be a multi-location group having product list spreading across an array of therapeutic segments. SMS was given the export house status in the year 1997-98. SMS is currently a listed company having ever appreciating international and domestic customer base.
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05

PEGS Boston Summit
Not Confirmed
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Mitapivat

About the Company : Synthimed Labs is a leading API manufacturer recognized for its high-quality and diverse range of Active Pharmaceutical Ingredients (APIs). Their product portfolio includes a wide ...

Synthimed Labs is a leading API manufacturer recognized for its high-quality and diverse range of Active Pharmaceutical Ingredients (APIs). Their product portfolio includes a wide array of APIs developed through advanced research and rigorous quality control processes.
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INTERMEDIATE SUPPLIERS

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01

PEGS Boston Summit
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CAS Number : 57184-25-5

End Use API : Mitapivat

About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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FDF Dossiers

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01

PEGS Boston Summit
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MITAPIVAT SULFATE

Brand Name : PYRUKYND

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2022-02-17

Application Number : 216196

Regulatory Info : RX

Registration Country : USA

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02

PEGS Boston Summit
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MITAPIVAT SULFATE

Brand Name : PYRUKYND

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Packaging :

Approval Date : 2022-02-17

Application Number : 216196

Regulatory Info : RX

Registration Country : USA

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03

PEGS Boston Summit
Not Confirmed
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MITAPIVAT SULFATE

Brand Name : PYRUKYND

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Packaging :

Approval Date : 2022-02-17

Application Number : 216196

Regulatory Info : RX

Registration Country : USA

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Patents & EXCLUSIVITIES

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ABOUT THIS PAGE

Looking for 2151847-10-6 / Mitapivat API manufacturers, exporters & distributors?

Mitapivat manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Mitapivat 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 Mitapivat manufacturer or Mitapivat supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mitapivat manufacturer or Mitapivat supplier.

PharmaCompass also assists you with knowing the Mitapivat API Price utilized in the formulation of products. Mitapivat API Price is not always fixed or binding as the Mitapivat Price is obtained through a variety of data sources. The Mitapivat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Mitapivat

Synonyms

Ag-348 sulfate hydrate, Mitapivat sulfate [usan], N4jta67v3o, Pyrukynd, Ag-348 hemisulfate sesquihydrate, Mitapivat sulfate (usan)

Cas Number

2151847-10-6

Unique Ingredient Identifier (UNII)

N4JTA67V3O

Mitapivat Manufacturers

A Mitapivat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitapivat, including repackagers and relabelers. The FDA regulates Mitapivat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitapivat 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 Mitapivat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Mitapivat Suppliers

A Mitapivat supplier is an individual or a company that provides Mitapivat active pharmaceutical ingredient (API) or Mitapivat finished formulations upon request. The Mitapivat suppliers may include Mitapivat API manufacturers, exporters, distributors and traders.

click here to find a list of Mitapivat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Mitapivat USDMF

A Mitapivat DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitapivat active pharmaceutical ingredient (API) in detail. Different forms of Mitapivat DMFs exist exist since differing nations have different regulations, such as Mitapivat USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Mitapivat DMF submitted to regulatory agencies in the US is known as a USDMF. Mitapivat USDMF includes data on Mitapivat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitapivat USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Mitapivat suppliers with USDMF on PharmaCompass.

Mitapivat GMP

Mitapivat 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 Mitapivat 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 Mitapivat GMP manufacturer or Mitapivat GMP API supplier for your needs.

Mitapivat CoA

A Mitapivat CoA (Certificate of Analysis) is a formal document that attests to Mitapivat's compliance with Mitapivat specifications and serves as a tool for batch-level quality control.

Mitapivat CoA mostly includes findings from lab analyses of a specific batch. For each Mitapivat 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.

Mitapivat may be tested according to a variety of international standards, such as European Pharmacopoeia (Mitapivat EP), Mitapivat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mitapivat 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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