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16 API Suppliers, 7 USDMF, 3 CEP/COS, 7 Listed Suppliers

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Synopsis

ACTIVE PHARMA INGREDIENTS

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Also known as: 557-04-0, Magnesium distearate, Magnesium octadecanoate, Dibasic magnesium stearate, Octadecanoic acid, magnesium salt, Magnesium(ii) stearate

Molecular Formula

C₃₆H₇₀MgO₄

Molecular Weight

591.2 g/mol

InChI Key

HQKMJHAJHXVSDF-UHFFFAOYSA-L

FDA UNII

70097M6I30

1 2D Structure

Magnesium Stearate API

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

magnesium;octadecanoate

2.1.2 InChI

InChI=1S/2C18H36O2.Mg/c2*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;/h2*2-17H2,1H3,(H,19,20);/q;;+2/p-2

2.1.3 InChI Key

HQKMJHAJHXVSDF-UHFFFAOYSA-L

2.1.4 Canonical SMILES

CCCCCCCCCCCCCCCCCC(=O)[O-].CCCCCCCCCCCCCCCCCC(=O)[O-].[Mg+2]

2.2 Other Identifiers

2.2.1 UNII

70097M6I30

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Aluminum Monostearate

2. Aluminum Tristearate

3. Ammonium Stearate

4. Calcium Stearate

5. Octadecanoic Acid

6. Sodium Stearate

7. Stearic Acid

8. Zinc Stearate

2.3.2 Depositor-Supplied Synonyms

1. 557-04-0

2. Magnesium Distearate

3. Magnesium Octadecanoate

4. Dibasic Magnesium Stearate

5. Octadecanoic Acid, Magnesium Salt

6. Magnesium(ii) Stearate

7. Stearic Acid, Magnesium Salt

8. Magnesium Stearate G

9. Magnesium Dioctadecanoate

10. Octadecanoic Acid, Magnesium Salt (2:1)

11. Chebi:9254

12. Synpro 90

13. 70097m6i30

14. Petrac Mg 20nf

15. Ns-m (salt)

16. Sm-p

17. Magnesium Stearate [jan]

18. Synpro Magnesium Stearate 90

19. Hsdb 713

20. Einecs 209-150-3

21. Magnesium Distearate, Pure

22. Np 1500

23. Sm 1000

24. Magnesium Stearate [jan:nf]

25. Ai3-01638

26. Magnesii Stearas

27. Unii-70097m6i30

28. Mfcd00036391

29. Magnesium Stearate Nf

30. Schembl935

31. Rashayan Magnesium Stearate

32. Octadecanoic Acid Magnesium Salt

33. Magnesium Stearate (jp17/nf)

34. Magnesium Stearate [ii]

35. Magnesium Stearate [mi]

36. Chembl2106633

37. Dtxsid2027208

38. Magnesium Stearate [hsdb]

39. Magnesium Stearate [inci]

40. Stearic Acid Magnesium(ii) Salt

41. Magnesium Stearate [vandf]

42. Magnesium Stearate [who-dd]

43. Akos015915201

44. Db14077

45. Magnesii Stearas [who-ip Latin]

46. Ft-0602789

47. S0238

48. D02189

49. A830764

50. Q416713

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	C₃₆H₇₀MgO₄
Molecular Weight	591.2 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	30
Exact Mass	590.5124524 g/mol
Monoisotopic Mass	590.5124524 g/mol
Topological Polar Surface Area	80.3 Å²
Heavy Atom Count	41
Formal Charge	0
Complexity	196
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	3

API SUPPLIERS

01

Jai Radhe Sales

India

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

CPHI Middle east

Not Confirmed

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India

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

02

Vasa Pharmachem

India

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

CPHI Middle east

Not Confirmed

Not Confirmed

06

3F Industries

India

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

CPHI Middle east

Not Confirmed

07

Mallinckrodt Pharmaceuticals

Ireland

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

CPHI Middle east

Not Confirmed

Not Confirmed

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India

Medlab Asia & Asia Health

Not Confirmed

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Listed Suppliers

01

Jai Radhe Sales

India

CPHI Middle east

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India

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Magnesium Stearate API

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.

02

Envee Drugs

India

CPHI Middle east

Not Confirmed

03

IQT Industrias Quimicas Taubate

Brazil

CPHI Middle east

Not Confirmed

04

Nitika Pharmaceutical Specialities

India

India

CPHI Middle east

Not Confirmed

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Drugs in Development

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DATA COMPILATION #PharmaFlow

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.

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