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Synopsis

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Chemistry

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Also known as: Lnp023, 1644670-37-0, Lnp-023, Iptacopan [inn], Iptacopan [usan], Nvp-lnp023-nx
Molecular Formula
C25H30N2O4
Molecular Weight
422.5  g/mol
InChI Key
RENRQMCACQEWFC-UGKGYDQZSA-N
FDA UNII
8E05T07Z6W

Iptacopan Hydrochloride
Iptacopan is an orally available, small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, iptacopan binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb). This limits the cleavage of C3 to the active fragment C3b and may prevent C3b-mediated extravascular hemolysis in certain complement-driven disorders such as paroxysmal nocturnal hemoglobinuria (PNH).
1 2D Structure

Iptacopan Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl]benzoic acid
2.1.2 InChI
InChI=1S/C25H30N2O4/c1-4-31-19-10-12-27(22(14-19)17-5-7-18(8-6-17)25(28)29)15-21-20-9-11-26-24(20)16(2)13-23(21)30-3/h5-9,11,13,19,22,26H,4,10,12,14-15H2,1-3H3,(H,28,29)/t19-,22-/m0/s1
2.1.3 InChI Key
RENRQMCACQEWFC-UGKGYDQZSA-N
2.1.4 Canonical SMILES
CCOC1CCN(C(C1)C2=CC=C(C=C2)C(=O)O)CC3=C(C=C(C4=C3C=CN4)C)OC
2.1.5 Isomeric SMILES
CCO[C@H]1CCN([C@@H](C1)C2=CC=C(C=C2)C(=O)O)CC3=C(C=C(C4=C3C=CN4)C)OC
2.2 Other Identifiers
2.2.1 UNII
8E05T07Z6W
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Lnp023

2. 1644670-37-0

3. Lnp-023

4. Iptacopan [inn]

5. Iptacopan [usan]

6. Nvp-lnp023-nx

7. Nvp-lnp023

8. 8e05t07z6w

9. 4-[(2s,4s)-4-ethoxy-1-[(5-methoxy-7-methyl-1h-indol-4-yl)methyl]piperidin-2-yl]benzoic Acid

10. 4-[(2~{s},4~{s})-4-ethoxy-1-[(5-methoxy-7-methyl-1~{h}-indol-4-yl)methyl]piperidin-2-yl]benzoic Acid

11. Benzoic Acid, 4-((2s,4s)-4-ethoxy-1-((5-methoxy-7-methyl-1h-indol-4-yl)methyl)-2-piperidinyl)-

12. Benzoic Acid, 4-[(2s,4s)-4-ethoxy-1-[(5-methoxy-7-methyl-1h-indol-4-yl)methyl]-2-piperidinyl]-

13. Iptacopan [who-dd]

14. Unii-8e05t07z6w

15. Chembl4594448

16. Schembl16400416

17. Gtpl10710

18. Us9682968, Example-26a

19. Bdbm160475

20. Ex-a5728

21. Who 11259

22. Zinc223246892

23. At30389

24. Compound 41 [pmid: 32073845]

25. Hy-127105

26. Cs-0093107

27. A935227

28. 4-((2s,4s)-(4-ethoxy-1-((5-methoxy-7-methyl-1h-indol-4-yl)methyl)piperidin-2-yl))benzoic Acid

29. 4-((2s,4s)-4-ethoxy-1-((5-methoxy-7-methyl-1h-indol-4-yl)methyl)piperidin-2-yl)benzoicacid

30. Jgq

2.4 Create Date
2015-02-16
3 Chemical and Physical Properties
Molecular Weight 422.5 g/mol
Molecular Formula C25H30N2O4
XLogP31.8
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count7
Exact Mass422.22055744 g/mol
Monoisotopic Mass422.22055744 g/mol
Topological Polar Surface Area74.8 Ų
Heavy Atom Count31
Formal Charge0
Complexity594
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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NDC API

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IPTACOPAN HYDROCHLORIDE

NDC Package Code : 0078-1455

Start Marketing Date : 2023-12-05

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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IPTACOPAN HYDROCHLORIDE

NDC Package Code : 44139-0100

Start Marketing Date : 2023-12-05

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Iptacopan

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Iptacopan Hydrochloride

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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HRV Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Iptacopan

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
HRV Global Life Sciences

04

Angene International

United Kingdom
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Angene International

United Kingdom
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Iptacopan

About the Company : Angene is pledged to providing quality chemicals for use in research and development and commercial manufacturing. Angenes offers over 100,000 products including lab reagents, inte...

Angene is pledged to providing quality chemicals for use in research and development and commercial manufacturing. Angenes offers over 100,000 products including lab reagents, intermediates, bulk commodities, agro-chemicals, natural ingredients and active pharmaceutical ingredients (APIs). In addition to the 100,000+ products, Angene offers custom synthesis of chemicals that are not commercially available.
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Iptacopan

About the Company : Founded by chemists with years of working experiences in famous CRO companies in China, Excenen Pharmatech experienced in organic chemistry expecially in medicinal chemistry resear...

Founded by chemists with years of working experiences in famous CRO companies in China, Excenen Pharmatech experienced in organic chemistry expecially in medicinal chemistry research/discovery fields. Excenen PharmaTech is dedicated to serve the pharmaceutical, scientific research and development industries for 10 years. During the past 10 years we supplied building blocks, small molecules, inhitbitors to world's leading companies like Janssen (Johnson&Johnson), Gilead, Abbvie..., Universities like Duke University, University of Chicago, University of Barcelona, University of Pécs etc.
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Iptacopan

About the Company : Sandoo Pharmaceuticals and Chemcials Co.,Ltd was established in 2009, with a young and active team, located in Ningbo, China. Specializes in exporting and importing pharmaceutica...

Sandoo Pharmaceuticals and Chemcials Co.,Ltd was established in 2009, with a young and active team, located in Ningbo, China. Specializes in exporting and importing pharmaceutical intermediates and chemical products as well as active pharmaceutical ingredients.
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Iptacopan Hydrochloride

About the Company : Viyash, true to its name, literally represents honesty and leadership in every sense. We are an integrated pharmaceutical company with a strong portfolio of niche formulations, ...

Viyash, true to its name, literally represents honesty and leadership in every sense. We are an integrated pharmaceutical company with a strong portfolio of niche formulations, APIs and advanced intermediates Viyash and its subsidiaries operate 10 API / Intermediate facilities with a combined capacity ~2000 KL and diversified capabilities in every aspect - small / large volume, potent / non-potent, regulated / semi-regulated markets. In addition, we also operate one formulation manufacturing facility in New Jersey, USA with a capacity of ~ 1.2 Bn units.
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Iptacopan Hydrochloride

About the Company : Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states...

Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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NOVARTIS

Switzerland
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IPTACOPAN HYDROCHLORIDE

Brand Name : FABHALTA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2023-12-05

Application Number : 218276

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

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Iptacopanum

Brand Name : Fabhalta

Dosage Form : Hard Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 29/08/2024

Application Number : 68603

Regulatory Info : Allowed

Registration Country : Switzerland

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Iptakopanhydrokloridmonohydrat

Brand Name : Fabhalta

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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Iptacopan

Brand Name : Fabhalta

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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Iptacopan Hydrochloride Monohydrate

Brand Name : Fabhalta

Dosage Form : Hard Capsule

Dosage Strength : 200MG

Packaging :

Approval Date : 11-07-2024

Application Number : 1241802002

Regulatory Info : Authorized

Registration Country : Spain

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Iptacopan Hydrochloride Monohydrate

Brand Name : Fabhalta

Dosage Form : Hard Capsules

Dosage Strength : 200mg

Packaging :

Approval Date : 17-05-2024

Application Number : 28106960523

Regulatory Info : Prescription

Registration Country : Denmark

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IPTACOPAN (IPTACOPAN HYDROCHLORIDE)

Brand Name : FABHALTA

Dosage Form : CAPSULE

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2554313

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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Iptacopan

Brand Name : Fabhalta

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Packaging : 56

Approval Date :

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Regulatory Info :

Registration Country : Australia

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Patents & EXCLUSIVITIES

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US Patents

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 10093663

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-3980

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-07-14

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 9682968

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 218276

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-07-14

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 12285422

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-4181

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-08-30

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 11603363

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 218276

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-05-25

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 12453726

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-4300

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-07-15

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 10093663

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-4161

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-07-14

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Switzerland
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IPTACOPAN HYDROCHLORIDE

US Patent Number : 12384758

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-3980

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-05-17

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Switzerland
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US Patent Number : 12384758

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-4161

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-05-17

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Switzerland
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IPTACOPAN HYDROCHLORIDE

US Patent Number : 11951101

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-3895

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-07-15

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 11723901

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-3980

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-08-30

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ABOUT THIS PAGE

Looking for 1644670-37-0 / Iptacopan Hydrochloride API manufacturers, exporters & distributors?

Iptacopan Hydrochloride manufacturers, exporters & distributors 1

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

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

API | Excipient name

Iptacopan Hydrochloride

Synonyms

Lnp023, 1644670-37-0, Lnp-023, Iptacopan [inn], Iptacopan [usan], Nvp-lnp023-nx

Cas Number

1644670-37-0

Unique Ingredient Identifier (UNII)

8E05T07Z6W

About Iptacopan Hydrochloride

Iptacopan is an orally available, small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, iptacopan binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb). This limits the cleavage of C3 to the active fragment C3b and may prevent C3b-mediated extravascular hemolysis in certain complement-driven disorders such as paroxysmal nocturnal hemoglobinuria (PNH).

Iptacopan Hydrochloride Manufacturers

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

Iptacopan Hydrochloride Suppliers

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

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

Iptacopan Hydrochloride 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 Iptacopan Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Iptacopan Hydrochloride 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 Iptacopan 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Iptacopan Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Iptacopan Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Iptacopan Hydrochloride suppliers with NDC on PharmaCompass.

Iptacopan Hydrochloride GMP

Iptacopan 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 Iptacopan Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Iptacopan Hydrochloride GMP manufacturer or Iptacopan Hydrochloride GMP API supplier for your needs.

Iptacopan Hydrochloride CoA

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

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

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