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Chemistry

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Also known as: 110-17-8, Trans-butenedioic acid, Allomaleic acid, Fumarate, Lichenic acid, Boletic acid
Molecular Formula
C4H4O4
Molecular Weight
116.07  g/mol
InChI Key
VZCYOOQTPOCHFL-OWOJBTEDSA-N
FDA UNII
88XHZ13131

Fumaric Acid
Fumaric acid is a metabolite found in the aging mouse brain.
1 2D Structure

Fumaric Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid
2.1.2 InChI
InChI=1S/C4H4O4/c5-3(6)1-2-4(7)8/h1-2H,(H,5,6)(H,7,8)/b2-1+
2.1.3 InChI Key
VZCYOOQTPOCHFL-OWOJBTEDSA-N
2.1.4 Canonical SMILES
C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
88XHZ13131
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (e)-2-butenedioic Acid

2. 2-butenedioic Acid

3. Ammonium Fumarate

4. Fumarate Dianion

5. Fumarate(2-)

6. Furamag

7. Mafusol

8. Magnesium Fumarate

9. Sodium Fumarate

2.3.2 Depositor-Supplied Synonyms

1. 110-17-8

2. Trans-butenedioic Acid

3. Allomaleic Acid

4. Fumarate

5. Lichenic Acid

6. Boletic Acid

7. (2e)-but-2-enedioic Acid

8. 2-butenedioic Acid

9. Tumaric Acid

10. Trans-1,2-ethylenedicarboxylic Acid

11. But-2-enedioic Acid

12. Allomalenic Acid

13. Trans-2-butenedioic Acid

14. (e)-2-butenedioic Acid

15. 2-butenedioic Acid, (e)-

16. Fumaricum Acidum

17. 2-butenedioic Acid (e)-

18. Kyselina Fumarova

19. Usaf Ek-p-583

20. Fema No. 2488

21. Butenedioic Acid

22. Butenedioic Acid, (e)-

23. (2e)-2-butenedioic Acid

24. (e)-but-2-enedioic Acid

25. 2-butenedioic Acid (2e)-

26. Caswell No. 465e

27. Nsc-2752

28. Fema Number 2488

29. 2-(e)-butenedioic Acid

30. 1,2-ethylenedicarboxylic Acid, (e)

31. Ccris 1039

32. Hsdb 710

33. Allomaleic-acid

34. U-1149

35. Boletic-acid

36. Trans-but-2-enedioic Acid

37. 1,2-ethenedicarboxylic Acid, Trans-

38. Epa Pesticide Chemical Code 051201

39. Fumaric Acid (nf)

40. Fumaric Acid [nf]

41. (e)-butenedioic Acid

42. Ai3-24236

43. 6915-18-0

44. Ins No.297

45. Chebi:18012

46. Ins-297

47. Nsc2752

48. Fc 33

49. 88xhz13131

50. Fum

51. 2-butenedioic Acid (2e)-, Homopolymer

52. E297

53. Lichenic Acid (van)

54. E-297

55. Dsstox_cid_1518

56. (e)-2-butenedioate

57. Dsstox_rid_76195

58. Dsstox_gsid_21518

59. Fumaric Acid 1000 Microg/ml In Acetonitrile:water

60. Kyselina Fumarova [czech]

61. (2e)-but-2-enedioate

62. Fumarsaeure

63. Donitic Acid

64. But-2-enedioicacid

65. 9003-16-1

66. Cas-110-17-8

67. Fumarate, 10

68. E-2-butenedioic Acid

69. Fumaric Acid (8ci)

70. Einecs 203-743-0

71. Fc 33 (acid)

72. Futrans-2-butenedioic Acid

73. Brn 0605763

74. Allomaleate

75. Boletate

76. Lichenate

77. Fumeric Acid

78. Unii-88xhz13131

79. Modified Gumrosin

80. Trans-butenedioate

81. Ncgc00091192-02

82. Fumaric Acid,(s)

83. Maleic Acid (ma)

84. Mfcd00002700

85. Fumaric Acid Solution

86. Trans-2-butenedioate

87. Fumaric Acid (fa)

88. 2-(e)-butenedioate

89. Fumaric Acid, 99%

90. Ethylenedicarboxylic Acid

91. (trans)-butenedioic Acid

92. F0067

93. Fumaric Acid, >=99%

94. Bmse000083

95. Fumaric Acid [ii]

96. Fumaric Acid [mi]

97. Ec 203-743-0

98. Wln: Qv1u1vq-t

99. Fumaric Acid [fcc]

100. Schembl1177

101. Fumaric Acid [fhfi]

102. Fumaric Acid [hsdb]

103. Fumaric Acid [inci]

104. Fumaric Acid [vandf]

105. 4-02-00-02202 (beilstein Handbook Reference)

106. Mls002454406

107. 2-butenedioic Acid, (2e)-

108. Fumaric Acid [mart.]

109. (2e)-2-butenedioic Acid #

110. Fumaric Acid [usp-rs]

111. Fumaric Acid [who-dd]

112. Chembl503160

113. Fumaric Acid (fragrance Grade)

114. Fumaricum Acidum [hpus]

115. Trans-1,2-ethylenedicarboxylate

116. Dtxsid3021518

117. Bdbm26122

118. Chebi:22958

119. 2(trans)-butenedioic Acid

120. Hms2270c12

121. Pharmakon1600-01301022

122. Fumaric Acid, >=99.0% (t)

123. Amy30339

124. Fumaric Acid [usp Impurity]

125. Str02646

126. Zinc3860193

127. Tox21_201769

128. Tox21_302826

129. 2-butenedioic Acid (2e)- (9ci)

130. Fumaric Acid, >=99%, Fcc, Fg

131. Nsc760395

132. S4952

133. Akos000118896

134. Fumaric Acid, Qnmr Standard For Dmso

135. Ccg-266065

136. Cs-w016599

137. Db01677

138. Hy-w015883

139. Nsc-760395

140. Ncgc00091192-01

141. Ncgc00091192-03

142. Ncgc00256360-01

143. Ncgc00259318-01

144. Bp-13087

145. Fumaric Acid, Tested According To Usp/nf

146. Ls-12976

147. Smr000112117

148. Fumaric Acid, Puriss., >=99.5% (t)

149. Fumaric Acid 100 Microg/ml In Acetonitrile

150. Malic Acid Impurity A [ep Impurity]

151. Fumaric Acid, Vetec(tm) Reagent Grade, 99%

152. 1, (e)

153. C00122

154. D02308

155. D85166

156. Q139857

157. Fumaric Acid, Bioreagent, Suitable For Cell Culture

158. J-002389

159. Fumarate; 2-butenedioic Acid; Trans-butenedioic Acid

160. Sodium Aurothiomalate Impurity B [ep Impurity]

161. F8886-8257

162. Fumaric Acid, Certified Reference Material, Tracecert(r)

163. 26b3632d-e93f-4655-90b0-3c17855294ba

164. Fumaric Acid, Anhydrous, Free-flowing, Redi-dri(tm), >=99%

165. Fumaric Acid, European Pharmacopoeia (ep) Reference Standard

166. Fumaric Acid, United States Pharmacopeia (usp) Reference Standard

167. Fumaric Acid Solution, Tracecert(r), 1h-qnmr Standard, 1 Mg/g In D2o

168. Fumaric Acid, Pharmaceutical Secondary Standard; Certified Reference Material

169. Fumaric Acid, Pharmagrade, Usp/nf, Manufactured Under Appropriate Gmp Controls For Pharma Or Biopharmaceutical Production.

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 116.07 g/mol
Molecular Formula C4H4O4
XLogP3-0.3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count2
Exact Mass116.01095860 g/mol
Monoisotopic Mass116.01095860 g/mol
Topological Polar Surface Area74.6 Ų
Heavy Atom Count8
Formal Charge0
Complexity119
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

Fumaric acid is used in oral pharmaceutical formulations and food products, and is generally regarded as a relatively nontoxic and nonirritant material.

Rowe, R.C., Sheskey, P.J., Quinn, M.E.; (Eds.), Handbook of Pharmaceutical Excipients 6th edition Pharmaceutical Press, London, England 2009, p. 277


Fumaric acid preparations are used as long term and effective treatment of psoriasis. /Fumaric acid preparation/

PMID:10627662 Raschka C, Koch Hj; Hum Exp Toxicol 18 (12): 738-9 (1999).


/EXPERIMENTAL THERAPY/ Fumaric acid and its esters (FAE) ... are already in use for treatment of psoriasis and are known to have an immunomodulatory effect ... A phase II clinical study in relapsing-remitting multiple sclerosis (RRMS) patients with the modified fumaric acid ester BG-12 showed as "proof of principle" in a frequent MRI design that FAE significantly reduce the number of gadolinium-enhancing lesions after 24 weeks of treatment. Further phase III studies have been started to explore the long-term efficacy of this substance ...

PMID:18210050 Stangel M et al; Nervenarzt 79 (2): 212-7 (2008).


/EXPERIMENTAL THERAPY/ Oral treatment of psoriasis on an outpatient basis, using a preparation containing fumaric acid derivatives, was evaluated as initial monotherapy (3 months) and as long-term basic therapy (12-14 months) in 13 and 11 patients, respectively. The course of the disease was analysed in each individual case. After completion of both parts of the trial, half of the patients that had only responded poorly to conventional antipsoriatic therapy showed a significant improvement which occurred after several weeks of treatment. In 4 patients the medication had to be stopped because of abdominal pain. No severe side effects, particularly of renal, hepatic or hematological nature, could be established. Studies in mice and rats disclosed only a low acute toxicity of the fumaric acid derivatives used. In additional analyses, hypotheses were dealt with concerning the mechanism of action of fumaric acid in psoriasis. To establish fumaric acid derivatives in the treatment of psoriasis, studies on chronic toxicity and pharmacokinetics will have to be conducted. Further clinical trials should evaluate a single fumaric acid derivative instead of mixtures. /Fumaric acid derivatives/

Bayard W et al; Hautarz (5): 279-85 (1987)


4.2 Drug Warning

Fumaric acid ...is generally regarded as a relatively nontoxic and nonirritant material. However, acute renal falure and other adverse reactions have occurred following the topical and systemic therapeutic use of fumaric acid and fumaric acid derivatives in the treatment of psoriasis or other skin disorders. Other adverse effects of oral therapy have included disturbances of liver function, gastrointestinal effects, and flushing.

Rowe, R.C., Sheskey, P.J., Quinn, M.E.; (Eds.), Handbook of Pharmaceutical Excipients 6th edition Pharmaceutical Press, London, England 2009, p. 277


Two patients who developed acute renal failure during therapy with fumaric acid esters /are discussed/. Histologic findings after renal biopsy in one patient were compatible with the diagnosis of acute tubular necrosis, and renal function was restored after cessation of the medication. The histologic diagnosis in the other patient was tubulo-interstitial nephritis, possibly reactive to acute tubular necrosis. The recovery of renal function was incomplete after 9 months. Two other patients had deterioration of renal function and proteinuria during therapy with fumaric acid-esters. The symptoms were completely reversible in one patient after discontinuation of the medication, and incompletely reversible in the other.

PMID:2772586 Roodnat JI et al; Schweiz Med Wochenschr 119 (23): 826-30 (1989).


24 days after starting treatment of psoriasis with fumaric acid derivatives (0.8-1.0 g orally, plus unknown quantities locally) a 21-year-old woman developed acute oliguric renal failure with a rise of serum creatinine levels to 1094 mmol/L (12.4 mg/dL). Deterioration of renal function had been preceded by severe abdominal symptoms with nausea, vomiting and colicky pain. On admission to hospital she was dehydrated with hyponatremia and hypokalemia. There was glomerular microhematuria, increased excretion of renal epithelia, and tubular proteinuria. Renal biopsy demonstrated acute tubular damage with vacuolization of proximal epithelia, dilated tubules and scattered necroses. After intermittent hemodialysis (13 courses over two weeks) renal function gradually recovered, as demonstrated at a follow-up examination four months after discharge. /Fumaric acid derivatives/

PMID:2361438 Dalhoff K et al; Dtsch Med Wochenschr 115 (26): 1014-7 (1990).


Apart from gastrointestinal, dermatological and hematological side-effects, transient renal damage was observed during treatment with fumaric acid. The case of a 38 year old woman who was treated with fumaric acid (420 mg bid) for 5 years before she complained of fatigue and weakness. According to clinical laboratory she had developed severe proximal tubular damage. Hypophosphatemia, glycosuria and proteinuria persisted although medication was stopped immediately. /Fumaric acid preparation/

PMID:10627662 Raschka C, Koch Hj; Hum Exp Toxicol 18 (12): 738-9 (1999).


5 Pharmacology and Biochemistry
5.1 ATC Code

D - Dermatologicals

D05 - Antipsoriatics

D05A - Antipsoriatics for topical use

D05AX - Other antipsoriatics for topical use

D05AX01 - Fumaric acid


5.2 Absorption, Distribution and Excretion

The total activity of labeled carbon dioxide in the blood entering and leaving the brain was determined following a single injection of fumarate-2-(14)C in four normal human subjects. Blood samples were drawn simultaneously from the femoral artery and the superior bulb of the internal jugular vein. Also, cerebrospinal fluid specimens were collected. Evidence from the experiments indicates that there was an immmediate formation of (14)CO2 by the brain after injection of the isotope. It suggests that fumarate penetrates the blood-brain barrier with little difficulty.

European Commission, ESIS; IUCLID Dataset, Fumaric acid (110-17-8) pp.39-40 (2000 CD-ROM edition). Available from, as of February 25, 2010: https://esis.jrc.ec.europa.eu/


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About the Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we supply following AP...

Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we supply following APIs and their intermediates with good quality and competitive price: Aztreonam,Doripenem, Dronedarone Hcl ,Erlotinib HCL, Febuxostat,Gemcitabine HCL, Ivabradine, Imatinib mesylate, Mecobalamin,Moxifloxacin, Nelarabine,Pemetrexed disodium, Posaconazole, Temozolomide, Voriconazole, Tebipenem pivoxil.NOTE: Products covered by valid patents in any country are not offered or supplied to these countries for commercial purpose.
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About the Company : Salvi Chemical Industries Ltd. founded in 1978, is India's leading manufacturer and exporter of chemical and pharmaceutical products that includes nutritional products, intermediat...

Salvi Chemical Industries Ltd. founded in 1978, is India's leading manufacturer and exporter of chemical and pharmaceutical products that includes nutritional products, intermediates, bulk drugs, veterinary products, sweetners, quinolines, triazole and selenium products. Salvi Chemical Industries Ltd. is the largest manufacturers of iron products (One stop for Iron Products) across the globe. We are also one of the largest manufacturers of Iodine and Quinoline products. With a rich tradition of unwavering quality and reliability, SCIL brings together a unique blend of modern, value-added research and deep knowledge of the chemical industry.
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G-1,5TH FLR.,KANMOOR HOUSE","city":"MUMBAI, MAHARASHTRA","supplier":"HENAN EME TECHNOLOGY ","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"SANJAY CHEMICALS (INDIA) PRIVATE LIMITED","customerCountry":"INDIA","quantity":"28000.00","actualQuantity":"28000","unit":"KGS","unitRateFc":"1","totalValueFC":"27136.2","currency":"USD","unitRateINR":"81.2","date":"21-Sep-2024","totalValueINR":"2274048","totalValueInUsd":"27136.2","indian_port":"JNPT","hs_no":"29171950","bill_no":"5724460","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"RM1, FLOOR 1, BUILDING 8, PHASE 3, ZHENGHONG CYBERPORT NO. 15 YINPING ROAD, ZHENGZHOU, CHINA ., , China China","customerAddress":"UNIT NO. 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Jubilee Hills, Film Nagar, Shaikpet, ,? Hyderabad , ?HYDERABAD ,? TELANGANA,? 500096","city":"","supplier":"JIANGSU GTIG HUATAI CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"TIANISH LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"20000.00","actualQuantity":"20000","unit":"KGS","unitRateFc":"1","totalValueFC":"19792.1","currency":"USD","unitRateINR":"83.2","date":"07-Oct-2024","totalValueINR":"1663060","totalValueInUsd":"19792.1","indian_port":"Vizag Sea","hs_no":"29171950","bill_no":"5986009","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"15-16F HUACHANG ORIENTAL PLAZA, RENMIN ROAD ZHANGJIAGANG-215600 CHINA CN","customerAddress":"Plot no 564-A-22, Road No 92 ,? Jubilee Hills, Film Nagar, Shaikpet, ,? Hyderabad , ?HYDERABAD ,? 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SHANGHAI COVAN CHEMICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"UNIFORM SYNTHETICS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"23000.00","actualQuantity":"23000","unit":"KGS","unitRateFc":"0.9","totalValueFC":"21831.9","currency":"USD","unitRateINR":"79.8","date":"10-Oct-2024","totalValueINR":"1834457","totalValueInUsd":"21831.9","indian_port":"JNPT","hs_no":"29171950","bill_no":"6059939","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"3RD FLOOR, NO.1990 LONGYANG ROAD, P UDONG NEW DISTRICT, SHANGHAI, 20120 4, CN","customerAddress":"413, GOYAL TRADE CENTRE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728498600,"product":"FUMARIC ACID EMPROVE ESSENTIAL CHP,NF,JPE 1PCS X 50KG","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"ROTTERDAM","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"3272.5","totalValueFC":"1952.2","currency":"INR","unitRateINR":"3280.7","date":"10-Oct-2024","totalValueINR":"164033.53","totalValueInUsd":"1952.2","indian_port":"JNPT","hs_no":"29171950","bill_no":"6062270","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728498600,"product":"FUMARIC ACID 99.5 % MINI FG IS NOT FOR MEDICAL USE (AS PER INV AND PL)","address":"129\/1\/A","city":"NANDESARI","supplier":"RENSIN CHEMICALS LIMITED","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"SUDEEP NUTRITION PRIVATE LIMITED","customerCountry":"INDIA","quantity":"54000.00","actualQuantity":"54000","unit":"KGS","unitRateFc":"1","totalValueFC":"53166","currency":"USD","unitRateINR":"82.7","date":"10-Oct-2024","totalValueINR":"4467352.5","totalValueInUsd":"53166","indian_port":"Mundra","hs_no":"29171950","bill_no":"6059729","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"ROOM A, 16F. 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","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"SALVI CHEMICAL INDUSTRIES","customerCountry":"INDIA","quantity":"125000.00","actualQuantity":"125000","unit":"KGS","unitRateFc":"1","totalValueFC":"124331.6","currency":"USD","unitRateINR":"83.6","date":"11-Oct-2024","totalValueINR":"10447156.25","totalValueInUsd":"124331.6","indian_port":"JNPT","hs_no":"29171950","bill_no":"6068741","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"NO. 9, BAIXIA ROAD, BAIXIA DISTRICT Nanjing, , CHINA SDNF CHINA","customerAddress":"214 BLUE ROSE INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"FUMARIC ACID EMPROVE ESSENTIAL CHP,NF,JPE 1PCS X 50KG","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"ROTTERDAM","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"2975","totalValueFC":"1774.7","currency":"INR","unitRateINR":"2982.4","date":"21-Oct-2024","totalValueINR":"149121.39","totalValueInUsd":"1774.7","indian_port":"JNPT","hs_no":"29171950","bill_no":"6247675","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729621800,"product":"FUMARIC ACID","address":"SAVGAN HEIGHT UNIT B 1003","city":"MUMBAI","supplier":"POLYNT SPA","supplierCountry":"ITALY","foreign_port":"S CRISTOBAL","customer":"SREDSTVA REGIONALE CHEMIE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"24","totalValueFC":"803.9","currency":"EUR","unitRateINR":"2702.1","date":"23-Oct-2024","totalValueINR":"67551.41","totalValueInUsd":"803.9","indian_port":"Bombay Air","hs_no":"29171950","bill_no":"6288421","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"S CRISTOBAL","supplierAddress":"SOCIO UNICO SEDE LEGALE E AMMINISTRATIVA: VIA ENRICO FERMI 51 24020-SCANZOROSCIATE (BG) ITALY","customerAddress":"SAVGAN HEIGHT UNIT B 1003"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"FUMARIC ACID","address":"306 3RD FLOOR WELLINGTON BUSINESS","city":"ANDHERI (E), MUMBAI","supplier":"JIANGSU GTIG HUATAI CO LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"AGARWAL LIFE SCIENCES ","customerCountry":"INDIA","quantity":"42000.00","actualQuantity":"42000","unit":"KGS","unitRateFc":"1","totalValueFC":"41187.7","currency":"USD","unitRateINR":"82.4","date":"26-Oct-2024","totalValueINR":"3460863","totalValueInUsd":"41187.7","indian_port":"JNPT","hs_no":"29171950","bill_no":"6356371","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"15-16 F HUACHANG ORIENTAL PLAZARENM IN ROAD ZHANGJIAGANGJIANGSU SDNF CHINA","customerAddress":"306 3RD FLOOR WELLINGTON BUSINESS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"FUMARIC ACID","address":"413, GOYAL TRADE CENTRE","city":"MUMBAI, MAHARASHTRA","supplier":"M\/S. SHANGHAI COVAN CHEMICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"UNIFORM SYNTHETICS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"10900.00","actualQuantity":"10900","unit":"KGS","unitRateFc":"1","totalValueFC":"10777.4","currency":"USD","unitRateINR":"83.1","date":"26-Oct-2024","totalValueINR":"905583.99","totalValueInUsd":"10777.4","indian_port":"JNPT","hs_no":"29171950","bill_no":"6354334","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"3RD FLOOR, NO.1990 LONGYANG ROAD, P UDONG NEW DISTRICT, SHANGHAI, 20120 4, CN","customerAddress":"413, GOYAL TRADE CENTRE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"FUMARIC ACID","address":"413, GOYAL TRADE CENTRE","city":"MUMBAI, MAHARASHTRA","supplier":"M\/S. SHANGHAI COVAN CHEMICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"UNIFORM SYNTHETICS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"12100.00","actualQuantity":"12100","unit":"KGS","unitRateFc":"1","totalValueFC":"11963.9","currency":"USD","unitRateINR":"83.1","date":"26-Oct-2024","totalValueINR":"1005281.31","totalValueInUsd":"11963.9","indian_port":"JNPT","hs_no":"29171950","bill_no":"6354334","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"3RD FLOOR, NO.1990 LONGYANG ROAD, P UDONG NEW DISTRICT, SHANGHAI, 20120 4, CN","customerAddress":"413, GOYAL TRADE CENTRE"}]
06-Jan-2021
31-Oct-2024
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DATA COMPILATION #PharmaFlow

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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.   

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https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

#PharmaFlow by PHARMACOMPASS
12 Sep 2024

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Medlab Asia & Asia Health
Not Confirmed

Fumaric Acid (200 mg)

CAS Number : 110-17-8

Quantity Per Vial :

Price ($) : 265

Catalog Number : 1286708

Current Lot : H1E328

Previous Lot : H0E328 (31-MAY-2015)

NDC Code :

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