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LGM Salcaprozate Sodium

Synopsis

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Chemistry

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Also known as: 203787-91-1, Snac, Sodium 8-(2-hydroxybenzamido)octanoate, E414, Salcaprozate sodium [usan], Sodium;8-[(2-hydroxybenzoyl)amino]octanoate

Molecular Formula

C₁₅H₂₀NNaO₄

Molecular Weight

301.31 g/mol

InChI Key

UOENJXXSKABLJL-UHFFFAOYSA-M

FDA UNII

1YTW0422YU

Salcaprozate Sodium is the sodium salt form of salcaprozate, an oral absorption promoter. Salcaprozate sodium may be used as a delivery agent to promote the oral absorption of certain macromolecules with poor bioavailability such as insulin and heparin.

1 2D Structure

Salcaprozate Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;8-[(2-hydroxybenzoyl)amino]octanoate

2.1.2 InChI

InChI=1S/C15H21NO4.Na/c17-13-9-6-5-8-12(13)15(20)16-11-7-3-1-2-4-10-14(18)19;/h5-6,8-9,17H,1-4,7,10-11H2,(H,16,20)(H,18,19);/q;+1/p-1

2.1.3 InChI Key

UOENJXXSKABLJL-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C1=CC=C(C(=C1)C(=O)NCCCCCCCC(=O)[O-])O.[Na+]

2.2 Other Identifiers

2.2.1 UNII

1YTW0422YU

2.3 Synonyms

2.3.1 MeSH Synonyms

1. N-(8-(2-hydroxybenzoyl)amino)caprylate

2. N-(8-(2-hydroxybenzoyl)amino)caprylate Sodium

3. N-snac

4. Snac Sodium

5. Sodium N-(8-(2-hydroxybenzoyl)amino)caprylate

2.3.2 Depositor-Supplied Synonyms

1. 203787-91-1

2. Snac

3. Sodium 8-(2-hydroxybenzamido)octanoate

4. E414

5. Salcaprozate Sodium [usan]

6. Sodium;8-[(2-hydroxybenzoyl)amino]octanoate

7. Octanoic Acid, 8-[(2-hydroxybenzoyl)amino]-, Monosodium Salt

8. Salcaprozate (sodium)

9. Sodium,8-[(2-hydroxybenzoyl)amino]octanoate

10. 1ytw0422yu

11. Sodium 8-[(2-hydroxybenzoyl)amino]octanoate

12. E-414

13. Sodium 8-((2-hydroxybenzoyl)amino)octanoate

14. Salcaprozate Sodium (usan)

15. Octanoic Acid, 8-((2-hydroxybenzoyl)amino)-, Monosodium Salt

16. Sodium Salcaprozate

17. Unii-1ytw0422yu

18. Salcaprozic Acid, Sodium Salt

19. E 414

20. Salcaprozate Sodium, 99%

21. Salcaprozic Acid Sodium Salt

22. Schembl825599

23. Chembl2107027

24. Dtxsid50174306

25. Amy24031

26. Ex-a3434

27. Mfcd00952954

28. Sodium8-(2-hydroxybenzamido)octanoate

29. Ac-31357

30. As-65676

31. P414

32. Hy-114299

33. Cs-0081977

34. Ft-0696582

35. D05787

36. I10998

37. A879665

38. Q27253228

39. Sodium 8-[(2-hydroxyphenyl)formamido]octanoate

40. Octanoic Acid, 8-[(2-hydroxybenzoyl)amino]-, Sodium Salt

41. Sodium,8-[(2-hydroxybenzoyl)amino]octanoate;sodium 8-(2-hydroxybenzamido)octanoate

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₂₀NNaO₄
Molecular Weight	301.31 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	9
Exact Mass	301.12900240 g/mol
Monoisotopic Mass	301.12900240 g/mol
Topological Polar Surface Area	89.5 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	312
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

API SUPPLIERS

01

LGM Pharma

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

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Ami Lifesciences Private Limited

India

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AMI Lifesciences is Driven by Chemistry. Powered by People.

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Zhejiang Hengkang Pharmaceutical

China

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Biophore India Pharmaceuticals Pvt...

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Chongqing Sintaho Pharmaceutical

China

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HRV Global Life Sciences

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Omgene Life Sciences Pvt. Ltd

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Hainan Poly Pharm

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Biophore India Pharmaceuticals Pvt L...

India

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Salcaprozate Sodium

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DMF Number : 40217

Submission : 2024-07-22

Status : Active

Type : IV

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Anhui Poly Pharm Co Ltd

China

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Anhui Beirui Pharmaceutical Technolo...

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Chongqing Bioland Pharmaceutical Ltd

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

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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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards. Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio. Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients. The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.