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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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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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VMF

NDC API

API REF. PRICE (USD/KG)

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FDF

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Europe

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Chemistry

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Also known as: 1035979-44-2, P005672 hcl, Sarecycline hcl, Wc3035, Sarecycline hydrochloride [usan], P005672 hydrochloride
Molecular Formula
C24H30ClN3O8
Molecular Weight
524.0  g/mol
InChI Key
JGPBDCKZLBSHOI-FIPJBXKNSA-N
FDA UNII
36718856JR

Sarecycline
1 2D Structure

Sarecycline

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S,4aS,5aR,12aR)-4-(dimethylamino)-1,10,11,12a-tetrahydroxy-7-[[methoxy(methyl)amino]methyl]-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide;hydrochloride
2.1.2 InChI
InChI=1S/C24H29N3O8.ClH/c1-26(2)18-13-8-11-7-12-10(9-27(3)35-4)5-6-14(28)16(12)19(29)15(11)21(31)24(13,34)22(32)17(20(18)30)23(25)33;/h5-6,11,13,18,28-29,32,34H,7-9H2,1-4H3,(H2,25,33);1H/t11-,13-,18-,24-;/m0./s1
2.1.3 InChI Key
JGPBDCKZLBSHOI-FIPJBXKNSA-N
2.1.4 Canonical SMILES
CN(C)C1C2CC3CC4=C(C=CC(=C4C(=C3C(=O)C2(C(=C(C1=O)C(=O)N)O)O)O)O)CN(C)OC.Cl
2.1.5 Isomeric SMILES
CN(C)[C@H]1[C@@H]2C[C@@H]3CC4=C(C=CC(=C4C(=C3C(=O)[C@@]2(C(=C(C1=O)C(=O)N)O)O)O)O)CN(C)OC.Cl
2.2 Other Identifiers
2.2.1 UNII
36718856JR
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (4s,4as,5ar,12as)-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-((methoxy(methyl)amino)methyl)-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro-2-tetracenecarboxamide

2. Sarecycline

3. Seysara

2.3.2 Depositor-Supplied Synonyms

1. 1035979-44-2

2. P005672 Hcl

3. Sarecycline Hcl

4. Wc3035

5. Sarecycline Hydrochloride [usan]

6. P005672 Hydrochloride

7. Sarecycline (hydrochloride)

8. Seysara

9. Po05672

10. Wc-3035

11. Po-05672

12. 36718856jr

13. 1035979-44-2 (hcl)

14. P-00562

15. (4s,4as,5ar,12as)-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-((methoxy(methyl)amino)methyl)-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Hydrochloride

16. Sarecycline Hydrochloride (usan)

17. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-7-((methoxymethylamino)methyl)-1,11-dioxo-, Hydrochloride (1:1), (4s,4as,5ar,12as)-

18. Unii-36718856jr

19. (4s,4as,5ar,12as)-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-{[methoxy(methyl)amino]methyl}-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Hydrochloride

20. Seysara (tn)

21. Sarecyclinep005672

22. Sarecycline(p005672)

23. Chembl2364633

24. Schembl22205222

25. Ex-a185

26. Dtxsid701027925

27. (4s,4as,5ar,12ar)-4-(dimethylamino)-1,10,11,12a-tetrahydroxy-7-[[methoxy(methyl)amino]methyl]-3,12-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide;hydrochloride

28. Hy-13858a

29. Mfcd24444565

30. Sarecycline Hydrochloride [mi]

31. Akos032947249

32. Ac-30259

33. As-75307

34. Sarecycline Hydrochloride [who-dd]

35. Cs-0008147

36. D10667

37. F17423

38. Sarecycline Hydrochloride [orange Book]

39. J-501482

40. Q27256532

41. (4s,4as,5ar,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-7-[(methoxymethylamino)methyl]-1,11-dioxo-2-naphthacenecarboxamide Hydrochloride

42. (4s,4as,5ar,12as)-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-((methoxymethylamino)methyl)-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Monohydrochloride

2.4 Create Date
2013-04-02
3 Chemical and Physical Properties
Molecular Weight 524.0 g/mol
Molecular Formula C24H30ClN3O8
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count10
Rotatable Bond Count5
Exact Mass523.1721426 g/mol
Monoisotopic Mass523.1721426 g/mol
Topological Polar Surface Area174 Ų
Heavy Atom Count36
Formal Charge0
Complexity1010
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


Dermatologic Agents

Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
Tetracycline-class Drug [EPC]; Tetracyclines [CS]; P-Glycoprotein Inhibitors [MoA]

API SUPPLIERS

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01

Metrochem API Private Limited

India

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

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BIO Partnering at JPM
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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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Metrochem

02

Omgene Life Sciences Pvt. Ltd

India

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

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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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

Apicore LLC

India

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

BIO Partnering at JPM
Not Confirmed
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Apicore LLC

India

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

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BIO Partnering at JPM
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04

Ningbo Inno Pharmchem

China

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

BIO Partnering at JPM
Not Confirmed
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05

Hangzhou Hairui Chemical

China

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

BIO Partnering at JPM
Not Confirmed
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Hangzhou Hairui Chemical

China

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

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BIO Partnering at JPM
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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06

Viruj Pharmaceuticals Pvt Ltd

India

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

BIO Partnering at JPM
Not Confirmed
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07

Aurobindo Pharma Limited

India

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

BIO Partnering at JPM
Not Confirmed
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NDC API

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Duphat
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SARECYCLINE HYDROCHLORIDE

NDC Package Code : 44657-0079

Start Marketing Date : 2018-02-12

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

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Duphat
Not Confirmed
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  • WHO-GMP

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

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Digital Content Digital Content

Sarecycline

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 ...

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

02

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Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Digital Content Digital Content

Sarecycline

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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03

Apicore LLC

India
Duphat
Not Confirmed
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Apicore LLC

India
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Sarecycline Hydrochloride

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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Duphat
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Sarecycline

About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...

Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
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Duphat
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Sarecycline Hydrochloride

About the Company : Hangzhou Hairui Chemical Co., Ltd. is located in the Zhongheng Century Science and Technology Park in Hangzhou, Zhejiang. It is an excellent manufacturer of organic compounds with ...

Hangzhou Hairui Chemical Co., Ltd. is located in the Zhongheng Century Science and Technology Park in Hangzhou, Zhejiang. It is an excellent manufacturer of organic compounds with a wide range of products, mainly including fluorine-containing compounds, boric acid series, amino acid series, non-natural amino acid series, peptide series, and Coupling agent series, organic catalyst series, chiral compound series, heterocyclic compound series and other pharmaceutical intermediates. The company has passed ISO 9001:2015 quality system certification, rigorous internal management, excellent product quality, and a vast market.
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Sarecycline Hydrochloride

About the Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom synthesis and manufact...

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Duphat
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Sarecycline

About the Company : Viruj Pharmaceuticals, an India-based company with a global presence, aims to develop & market complex, technology-driven APIs. It offers contract API manufacturing for innovative ...

Viruj Pharmaceuticals, an India-based company with a global presence, aims to develop & market complex, technology-driven APIs. It offers contract API manufacturing for innovative companies globally, & APIs for generic companies. Viruj Pharmaceuticals adheres to quality systems defined in Schedule M, Schedule L, ICH Q7 & TRS guidelines & leads in process validation, cleaning validation, analytical method transfers & process technology. It ensures GMP compliance at its facility. Viruj seeks to develop APIs via continuous Flow Technology & has invested in the requisite infrastructure for developing APIs using Flow Chemistry techniques.
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ABOUT THIS PAGE

Sarecycline Manufacturers

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

Sarecycline Suppliers

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

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

Sarecycline 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 Sarecycline as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Sarecycline 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 Sarecycline 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 Sarecycline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sarecycline NDC to their finished compounded human drug products, they may choose to do so.

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

Sarecycline GMP

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

Sarecycline CoA

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

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

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