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Chemistry

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Also known as: Butanedioic acid, 110-15-6, Amber acid, Wormwood acid, Asuccin, Dihydrofumaric acid
Molecular Formula
C4H6O4
Molecular Weight
118.09  g/mol
InChI Key
KDYFGRWQOYBRFD-UHFFFAOYSA-N
FDA UNII
AB6MNQ6J6L

Succinic Acid
A water-soluble, colorless crystal with an acid taste that is used as a chemical intermediate, in medicine, the manufacture of lacquers, and to make perfume esters. It is also used in foods as a sequestrant, buffer, and a neutralizing agent. (Hawley's Condensed Chemical Dictionary, 12th ed, p1099; McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1851)
1 2D Structure

Succinic Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
butanedioic acid
2.1.2 InChI
InChI=1S/C4H6O4/c5-3(6)1-2-4(7)8/h1-2H2,(H,5,6)(H,7,8)
2.1.3 InChI Key
KDYFGRWQOYBRFD-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C(CC(=O)O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
AB6MNQ6J6L
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1,2 Ethanedicarboxylic Acid

2. 1,2-ethanedicarboxylic Acid

3. 1,4 Butanedioic Acid

4. 1,4-butanedioic Acid

5. Ammonium Succinate

6. Butanedioic Acid

7. Potassium Succinate

8. Succinate

9. Succinate, Ammonium

10. Succinate, Potassium

2.3.2 Depositor-Supplied Synonyms

1. Butanedioic Acid

2. 110-15-6

3. Amber Acid

4. Wormwood Acid

5. Asuccin

6. Dihydrofumaric Acid

7. Katasuccin

8. 1,2-ethanedicarboxylic Acid

9. Bernsteinsaure

10. Ethylenesuccinic Acid

11. 1,4-butanedioic Acid

12. Wormwood

13. Succinicum Acidum

14. Butandisaeure

15. Acidum Succinicum

16. Butanedionic Acid

17. Kyselina Jantarova

18. Butane Diacid

19. Ethylene Dicarboxylic Acid

20. Spirit Of Amber

21. Bernsteinsaure [german]

22. Kyselina Jantarova [czech]

23. Ammonium Succinate

24. Hsdb 791

25. Succinic-acid

26. Mfcd00002789

27. Succ

28. Nsc 106449

29. Ai3-06297

30. Ab6mnq6j6l

31. Nsc-106449

32. Butanedioic Acid, Homopolymer

33. E363

34. Fema No. 4719

35. Chebi:15741

36. C4-beta-polymorph

37. Nsc25949

38. Succinicacid(industrialgrade&foodgrade)

39. Ncgc00159372-02

40. Ncgc00159372-04

41. Succinellite

42. Acide Succinique

43. Sal Succini

44. Acid Of Amber

45. Dsstox_cid_3602

46. Wln: Qv2vq

47. Dsstox_rid_77102

48. Dsstox_gsid_23602

49. 26776-24-9

50. Sin

51. Ethylene Succinic Acid

52. Ethanedicarboxylic Acid

53. Bernsteinsaeure

54. Sodium Succinate (anhydrous)

55. Succinate, 9

56. Acide Butanedioique

57. Cas-110-15-6

58. Succinic Acid [nf]

59. Succinic Acid (8ci)

60. Butanedioic Acid (9ci)

61. Einecs 203-740-4

62. Unii-ab6mnq6j6l

63. Brn 1754069

64. Dihydrofumarate

65. Succinicate

66. Butanedioic Acid Diammonium Salt

67. Salt Of Amber

68. 1cze

69. Nat.succinic Acid

70. 1,4-butanedioate

71. Succinic Acid, 6

72. Succinic Acid, Fcc

73. Succinic Acide,(s)

74. Succinic Acid (sa)

75. 1,4-butandioic Acid

76. Succinic Acid, 99%

77. Succinic Acid, Natural

78. 4lh2

79. 1,2-ethanedicarboxylate

80. Substrate Analogue, 11

81. Suc

82. Succinic Acid, Acs Grade

83. Bmse000183

84. Bmse000968

85. Chembl576

86. Ec 203-740-4

87. Succinic Acid [ii]

88. Succinic Acid [mi]

89. Hooc-ch2-ch2-cooh

90. Succinic Acid [fcc]

91. A 12084

92. Succinic Acid [hsdb]

93. Succinic Acid [inci]

94. 4-02-00-01908 (beilstein Handbook Reference)

95. Succinic Acid [vandf]

96. Succinic Acid [mart.]

97. Gtpl3637

98. Succinic Acid [usp-rs]

99. Succinic Acid [who-dd]

100. Dtxsid6023602

101. Succinicum Acidum [hpus]

102. Bdbm26121

103. Succinic Acid (butanedioic Acid)

104. Hms3885o04

105. Zinc895030

106. Hy-n0420

107. Str02803

108. Tox21_111612

109. Tox21_201918

110. Tox21_303247

111. Bbl002473

112. Lmfa01170043

113. Nsc-25949

114. Nsc106449

115. S3791

116. Stk387105

117. Succinic Acid [usp Impurity]

118. Succinic Acid, >=99%, Fcc, Fg

119. Succinic Acid, Bioxtra, >=99.0%

120. Akos000118899

121. Tox21_111612_1

122. Ccg-266069

123. Db00139

124. Ncgc00159372-03

125. Ncgc00159372-05

126. Ncgc00159372-06

127. Ncgc00257092-01

128. Ncgc00259467-01

129. Succinic Acid, Acs Reagent, >=99.0%

130. Bp-21128

131. Succinic Acid, Reagentplus(r), >=99.0%

132. Adipic Acid Impurity B [ep Impurity]

133. Cs-0008946

134. Ft-0652509

135. Ft-0773657

136. N1941

137. S0100

138. Succinic Acid 100 Microg/ml In Acetonitrile

139. Succinic Acid, P.a., Acs Reagent, 99.0%

140. Succinic Acid, Saj First Grade, >=99.0%

141. Succinic Acid High Purity Grade 2.5kg

142. Succinic Acid, Purum P.a., >=99.0% (t)

143. Succinic Acid, Saj Special Grade, >=99.5%

144. 1,4-butanedioic Acid (succinic Acid)

145. A14596

146. C00042

147. D85169

148. Succinic Acid, Vetec(tm) Reagent Grade, 98%

149. Ab01332192-02

150. Q213050

151. Sr-01000944556

152. J-002386

153. Sr-01000944556-2

154. Z57127453

155. F2191-0239

156. 37e8fffb-70da-4399-b724-476bd8715ef0

157. Succinic Acid, Certified Reference Material, Tracecert(r)

158. Succinic Acid, Puriss. P.a., Acs Reagent, >=99.5% (t)

159. Succinic Acid, United States Pharmacopeia (usp) Reference Standard

160. Succinic Acid, Matrix Substance For Maldi-ms, >=99.5% (t), Ultra Pure

161. Succinic Acid, Anhydrous, Free-flowing, Redi-dri(tm), Acs Reagent, >=99.0%

162. Succinic Acid, Bioreagent, Suitable For Cell Culture, Suitable For Insect Cell Culture

163. Succinic Acid, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 118.09 g/mol
Molecular Formula C4H6O4
XLogP3-0.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count3
Exact Mass118.02660867 g/mol
Monoisotopic Mass118.02660867 g/mol
Topological Polar Surface Area74.6 Ų
Heavy Atom Count8
Formal Charge0
Complexity92.6
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

/EXPTL THER/ Succinic acid (100 mM) significantly inhibited systemic anaphylaxis induced by compound 48/80 /a potent mast cell degranulator/ in mice and dose-dependently inhibited local anaphylaxis activated by anti-dinitrophenyl IgE. Further 10 and 100 mM significantly inhibited histamine release from rat peritoneal mast cells activated by compound 48/80 or anti-dinitrophenyl IgE. In addition succinic acid (0.1 and 1 mM) had a significant inhibitory effect on anti-dinitrophenyl IgE-induced tumor necrosis factor-alpha secretion from rat peritoneal mast cells. The level of cyclic AMP in rat peritoneal mast cells, when succinic acid (100 mM) was added, transiently and significantly increased about 4 times compared with that of basal cells. These results suggest a possible use of succinic acid in managing mast cell-dependent anaphylaxis.

Kim HM et al;


4.2 Drug Indication

For nutritional supplementation, also for treating dietary shortage or imbalance


5 Pharmacology and Biochemistry
5.1 Absorption, Distribution and Excretion

Succinic acid occurs normally in human urine (1.9-8.8 mg/L).

Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. V5 758


5.2 Metabolism/Metabolites

Succinic acid is a normal intermediary metabolite and a constituent of the citric acid cycle. It is readily metabolized when administered to animals, but may be partly excreted unchanged in the urine if large doses are fed.

Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. V5 757


5.3 Mechanism of Action

Succinate is an essential component of the Krebs or citric acid cycle and serves an electron donor in the production of fumaric acid and FADH2. It also has been shown to be a good "natural" antibiotic because of its relative acidic or caustic nature (high concentrations can even cause burns). Succinate supplements have been shown to help reduce the effects of hangovers by activating the degradation of acetaldehyde - a toxic byproduct of alcohol metabolism - into CO2 and H2O through aerobic metabolism. Succinic acid has been shown to stimulate neural system recovery and bolster the immune system. Claims have also been made that it boosts awareness, concentration and reflexes.


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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Succinic Acid

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
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Succinic Acid

About the Company : QUALITY CHEMICALS, SL is a fine chemicals manufacturer of pure salts (mineral, metallic, organic, etc.), solvents, acids, basis and some organics. Our products are destined to a wi...

QUALITY CHEMICALS, SL is a fine chemicals manufacturer of pure salts (mineral, metallic, organic, etc.), solvents, acids, basis and some organics. Our products are destined to a wide range of industries, among them: pharmaceutical, laboratory reagent, food and cosmetics. Customized synthesis, purification, packaging and labelling are available. All these products are produced under international standards at our two plants, one of which works on GMP conditions. Furthermore, Quality Chemicals develops and manufactures tailored made chemicals on GMP basis, under confidential agreement. We can be your GMP partner!
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GROUP","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"4666.8","totalValueFC":"2806.4","currency":"INR","unitRateINR":"4678.5","date":"20-May-2024","totalValueINR":"233923.15","totalValueInUsd":"2806.4","indian_port":"JNPT","hs_no":"29171930","bill_no":"3572763","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"Frankfurter Strasse 250, 64293 Darmstadt,(BENEFICIARY MERCKFINANCIALSSERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716143400,"product":"SUCCINIC ACID CRYST., EMPROVE ESSENTIAL CHP,NF,JPE,ACS 7PCSX 5KG","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"ROTTERDAM","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"35.00","actualQuantity":"35","unit":"KGS","unitRateFc":"4666.8","totalValueFC":"1964.5","currency":"INR","unitRateINR":"4678.5","date":"20-May-2024","totalValueINR":"163746.2","totalValueInUsd":"1964.5","indian_port":"JNPT","hs_no":"29171930","bill_no":"3572763","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"Frankfurter Strasse 250, 64293 Darmstadt,(BENEFICIARY MERCKFINANCIALSSERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716402600,"product":"* LAB CHEMICALS - 2,3-DIHYDROXYSUCCINIC ACID - CS-0022654 -526-83-0","address":"102\/12 KRISHNA GREENLAND PARK,KASA","city":"THANE,MAHARASHTRA","supplier":"SHANGHAI KAIXIN PHARMACEUTICALS CO.","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"JINAY PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1000","unit":"GMS","unitRateFc":"0","totalValueFC":"35.1","currency":"USD","unitRateINR":"2.9","date":"23-May-2024","totalValueINR":"2928.63","totalValueInUsd":"35.1","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"3632433","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":",LTD ROOM 502,5\/F NO.2 BUILDING 720CAILUN RD ZHANGJIANG HIGH-TECH PARKSHANGHAI 201203 CHINA","customerAddress":"102\/12 KRISHNA GREENLAND PARK,KASA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716834600,"product":"SUCCINIC ACID CRYST., EMPROVE ESSENTIAL CHP,NF,JPE,ACS 10PCS X 5KG","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":"4666.8","totalValueFC":"2806.4","currency":"INR","unitRateINR":"4678.5","date":"28-May-2024","totalValueINR":"233923.15","totalValueInUsd":"2806.4","indian_port":"JNPT","hs_no":"29171930","bill_no":"3705210","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"Frankfurter Strasse 250, 64293 Darmstadt,(BENEFICIARY MERCKFINANCIALSSERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716834600,"product":"SUCCINIC ACID CRYST., EMPROVE ESSENTIAL CHP,NF,JPE,ACS 7PCSX 5KG","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"ROTTERDAM","customer":"MERCK 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LIMITED","customerCountry":"INDIA","quantity":"175.00","actualQuantity":"175","unit":"KGS","unitRateFc":"10.4","totalValueFC":"2219.2","currency":"EUR","unitRateINR":"1058.6","date":"09-Jun-2024","totalValueINR":"185254.34","totalValueInUsd":"2219.2","indian_port":"Madras Air","hs_no":"29349990","bill_no":"3910119","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CHEMIN DE PRE FLEURI6, 1006 LAUSANNESDNF SWITZERLAND","customerAddress":"3\/62 A SAMUDRA DWAR SALAI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718649000,"product":"1760275 SUCCINIC ACID, WQ (R&D FOR ELECTROPLATING PREPERATION)","address":"66 KM STONE, N H 8,DELHI JAIPUR HI","city":"VILL SIDHRAWALI,HARYANA","supplier":"ATOTECH DEUTSCHLAND GMBH & CO. KG","supplierCountry":"GERMANY","foreign_port":"BERLIN","customer":"ATOTECH DEVELOPMENT CENTER PVT LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"28.7","totalValueFC":"2020.5","currency":"EUR","unitRateINR":"3373.5","date":"18-Jun-2024","totalValueINR":"168672.87","totalValueInUsd":"2020.5","indian_port":"Delhi Air","hs_no":"29171930","bill_no":"4061825","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"BERLIN","supplierAddress":"AHORNALLE 4, D-16818 WERDERSDNFSDNF GERMANY","customerAddress":"66 KM STONE, N H 8,DELHI JAIPUR HI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724178600,"product":"SUCCINIC ACID CRYST., EMPROVE ESSENTIAL CHP,NF,JPE,ACS 11PCS X 5KG","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"55.00","actualQuantity":"55","unit":"KGS","unitRateFc":"5646.8","totalValueFC":"3711.9","currency":"INR","unitRateINR":"5660.9","date":"21-Aug-2024","totalValueINR":"311351.76","totalValueInUsd":"3711.9","indian_port":"Bombay Air","hs_no":"29171930","bill_no":"5165914","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darmstadt,(BENEFICIARY MERCKFINANCIALSSERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725993000,"product":"SUCCINIC ACID CRYST., EMPROVE ESSENTIAL CHP,NF,JPE,ACS 1PCSX 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":"3121.4","totalValueFC":"1867","currency":"INR","unitRateINR":"3129.2","date":"11-Sep-2024","totalValueINR":"156459.53","totalValueInUsd":"1867","indian_port":"JNPT","hs_no":"29171930","bill_no":"5550454","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":"Q3","strtotime":1727461800,"product":"VITA SOFT PEEL BIO-BASED SUCCINIC ACID 99,5% MIN. (VT020PR.0C025K) (RAW MATERIAL FOR COSMETIC USE)","address":"509,SHAH NIHAR (WORLI) INDL.ESTAT","city":"WORLI, MUMBAI, MAHARASHTRA.","supplier":"QUIMIVITA PRODUCTS SL","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VALUETREE INGREDIENTS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"6.9","totalValueFC":"434.1","currency":"EUR","unitRateINR":"1455.3","date":"28-Sep-2024","totalValueINR":"36381.9","totalValueInUsd":"434.1","indian_port":"Bombay Air","hs_no":"29171930","bill_no":"5858196","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"BALMES 245,6 PLANTA-08006BARCELONA SDNF SDNF SPAIN","customerAddress":"509,SHAH NIHAR (WORLI) INDL.ESTAT"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728844200,"product":"SUCCINIC ACID CRYST., EMPROVE ESSENTIAL CHP,NF,JPE,ACS 1PCSX 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":"3121.4","totalValueFC":"1862","currency":"INR","unitRateINR":"3129.2","date":"14-Oct-2024","totalValueINR":"156459.53","totalValueInUsd":"1862","indian_port":"JNPT","hs_no":"29171930","bill_no":"6110633","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,"}]
11-Jan-2021
14-Oct-2024
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INTERMEDIATES SUPPLIERS

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Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

CAS Number : 176380-53-3

End Use API : Succinic Acid

About The Company : USV is a leading health care company with focus on Active Pharmaceutical Ingredients (marketed globally with emphasis on regulated markets of USA, European Unio...

USV Private Limited
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FDF Dossiers

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Succinic Acid; Potassium Citrate; L-Tartaric Acid; Potassium hydrogen carbonate

Brand Name : Potassion

Dosage Form : Granules

Dosage Strength : 100MG; 250MG; 50MG; 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Listed Dossiers

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Succinic Acid; Potassium Citrate; L-Tartaric Acid; Potassium hydrogen carbonate

Brand Name : Potassion

Dosage Form : Granules

Dosage Strength : 100MG; 250MG; 50MG; 50...

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Succinic Acid; Potassium Citrate; L-Tartaric Acid; Potassium hydrogen carbonate

Dosage : Granules

Dosage Strength : 100MG; 250MG; 50MG; 50...

Brand Name : Potassion

Approval Date :

Application Number :

Registration Country : Italy

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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

NEWS #PharmaBuzz

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https://www.pharmaceutical-technology.com/contractors/api-biologics/pfanstiehl/pressreleases/succinic-acid-excipient-grade/

PTECHNOLOGY
29 Nov 2024

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