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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

2 API Suppliers, 1 USDMF, 1 Listed Suppliers, $ API Reference Price

2 API Suppliers
1 USDMF
1 Listed Suppliers
$ API Reference Price

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 1 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
1 NEWS #PharmaBuzz

MARKET PLACE

8 APIs

marketPlace
8 APIs

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

otherSolutions
1 USP
1 Others

ANALYTICAL

1 Analytical Methods

otherMethods
1 Analytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 2-imino-1-methylimidazolidin-4-one, 1-methylglycocyamidine, 1-methylhydantoin-2-imide, 2-amino-3-methyl-4h-imidazol-5-one, Kreatininum, Kreatinin

Molecular Formula

C₄H₇N₃O

Molecular Weight

113.12 g/mol

InChI Key

DDRJAANPRJIHGJ-UHFFFAOYSA-N

FDA UNII

AYI8EX34EU

Creatinine is a metabolite found in the aging mouse brain.

1 2D Structure

Creatinine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-amino-3-methyl-4H-imidazol-5-one

2.1.2 InChI

InChI=1S/C4H7N3O/c1-7-2-3(8)6-4(7)5/h2H2,1H3,(H2,5,6,8)

2.1.3 InChI Key

DDRJAANPRJIHGJ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN1CC(=O)N=C1N

2.2 Other Identifiers

2.2.1 UNII

AYI8EX34EU

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Creatinine Sulfate Salt

2. Krebiozen

3. Salt, Creatinine Sulfate

4. Sulfate Salt, Creatinine

2.3.2 Depositor-Supplied Synonyms

1. 2-imino-1-methylimidazolidin-4-one

2. 1-methylglycocyamidine

3. 1-methylhydantoin-2-imide

4. 2-amino-3-methyl-4h-imidazol-5-one

5. Kreatininum

6. Kreatinin

7. 2-amino-1-methyl-1,5-dihydro-4h-imidazol-4-one

8. Nsc-13123

9. Chebi:16737

10. 2-amino-1-methyl-2-imidazolin-4-one

11. 2-amino-1,5-dihydro-1-methyl-4h-imidazol-4-one

12. Ncgc00095762-01

13. Creatinine (van) (8ci)

14. Dsstox_cid_25987

15. Dsstox_rid_81274

16. Dsstox_gsid_45987

17. 4h-imidazol-4-one, 2-imino-1,5-dihydro-1-methyl-

18. Cas-60-27-5

19. Creatinina

20. Creatinine, Anhydrous

21. Spectrum_000429

22. Creatinine [ii]

23. Creatinine [mi]

24. Spectrum2_000764

25. Spectrum3_001717

26. Spectrum4_001806

27. Spectrum5_000511

28. Bmse000155

29. Bmse000789

30. Bmse001001

31. Creatinine [mart.]

32. Creatinine [usp-rs]

33. Creatinine [who-dd]

34. Schembl16295

35. Bspbio_003334

36. Kbiogr_002415

37. Kbioss_000909

38. Mls001306430

39. Chembl65567

40. Divk1c_000351

41. Spectrum1600300

42. Spbio_000808

43. Creatinine, Anhydrous, >=98%

44. Hms501b13

45. Kbio1_000351

46. Kbio2_000909

47. Kbio2_003477

48. Kbio2_006045

49. Kbio3_002554

50. Ninds_000351

51. Creatinine, 98.5-102.0%

52. Hms2233p20

53. Hms3372l11

54. Pharmakon1600-01600300

55. Zinc967189

56. Tox21_111516

57. Ccg-40153

58. Nsc760435

59. S3102

60. Stk530885

61. Stl268897

62. 2-imino-1-methyl-imidazolidin-4-one

63. Akos000121140

64. Akos005458367

65. Tox21_111516_1

66. 2-imino-1-methyl-4-imidazolidinone #

67. Creatinine, Nist(r) Srm(r) 914a

68. Nsc-760435

69. Sdccgmls-0066864.p001

70. Idi1_000351

71. Ncgc00095762-02

72. Ncgc00095762-04

73. Ncgc00247664-01

74. 1-methylhydantoin-2-imide [inci]

75. 4h-imidazol-4-one,5-dihydro-1-methyl-

76. As-12671

77. Smr000718791

78. Imidazolidin-4-one, 2-imino-1-methyl

79. 2-amino-1-methyl-1,5-dihydro-imidazol-4-one

80. C-8560

81. C00791

82. D03600

83. Ab00052404_03

84. Ab00052404_04

85. 059c730

86. 2-amino-4,5-dihydro-1-methyl-1h-imidazol-4-one

87. 2-imino-1,5-dihydro-1-methyl-4h-imidazol-4-one

88. Sr-01000837526

89. Sr-01000837526-3

90. W-203248

91. F0001-1578

92. C5cf605c-9352-48f2-a5a4-561b97d42c30

93. Creatinine, United States Pharmacopeia (usp) Reference Standard

94. Creatinine, Pharmaceutical Secondary Standard; Certified Reference Material

95. 2-amino-1-methyl-2-imidazolin-4-one, 2-imino-1-methylimidazolidin-4-one, 2-imino-n-methylhydantoin

96. Creatinine Solution, 2.0 Mg/ml In Methanol: Water (1:1), Certified Reference Material, Ampule Of 1 Ml

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	C₄H₇N₃O
Molecular Weight	113.12 g/mol
XLogP3	-1.8
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	0
Exact Mass	113.058911855 g/mol
Monoisotopic Mass	113.058911855 g/mol
Topological Polar Surface Area	58.7 Å²
Heavy Atom Count	8
Formal Charge	0
Complexity	151
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	1

API SUPPLIERS

01

S D Fine Chem Limited

India

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

American Pharma Summit

Not Confirmed

02

Biosynth AG

Switzerland

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

American Pharma Summit

Not Confirmed

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USDMF

01

Sd Fine Chem Ltd

India

Compamed

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

01

Biosynth AG

Switzerland

Compamed

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

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.