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Benzocaine

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1 JDMF
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8 Listed Dossiers

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3 Zhejiang Huakang Pharmaceutical

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Pharm-Rx Benzocaine

Synopsis

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Chemistry

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Also known as: Ethyl 4-aminobenzoate, 94-09-7, Ethyl aminobenzoate, Ethyl p-aminobenzoate, Americaine, Anaesthesin

Molecular Formula

C₉H₁₁NO₂

Molecular Weight

165.19 g/mol

InChI Key

BLFLLBZGZJTVJG-UHFFFAOYSA-N

FDA UNII

U3RSY48JW5

A surface anesthetic that acts by preventing transmission of impulses along nerve fibers and at nerve endings.

Benzocaine is a Standardized Chemical Allergen. The physiologic effect of benzocaine is by means of Increased Histamine Release, and Cell-mediated Immunity.

1 2D Structure

Benzocaine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

ethyl 4-aminobenzoate

2.1.2 InChI

InChI=1S/C9H11NO2/c1-2-12-9(11)7-3-5-8(10)6-4-7/h3-6H,2,10H2,1H3

2.1.3 InChI Key

BLFLLBZGZJTVJG-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCOC(=O)C1=CC=C(C=C1)N

2.2 Other Identifiers

2.2.1 UNII

U3RSY48JW5

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 4-aminobenzoic Acid Ethyl Ester

2. Acetate, Benzocaine

3. Americaine

4. Anaesthesin

5. Anesthesin

6. Bensokain

7. Benzocaine Acetate

8. Benzocaine Formate

9. Benzocaine Hydrobromide

10. Benzocaine Hydrochloride

11. Benzocaine Methanesulfonate

12. Ethoform

13. Ethyl Aminobenzoate

14. Formate, Benzocaine

15. Hydrobromide, Benzocaine

16. Hydrochloride, Benzocaine

17. Methanesulfonate, Benzocaine

2.3.2 Depositor-Supplied Synonyms

1. Ethyl 4-aminobenzoate

2. 94-09-7

3. Ethyl Aminobenzoate

4. Ethyl P-aminobenzoate

5. Americaine

6. Anaesthesin

7. Parathesin

8. Norcaine

9. Parathesine

10. Anesthesin

11. 4-aminobenzoic Acid Ethyl Ester

12. Ethoform

13. Orthesin

14. Amben Ethyl Ester

15. P-carbethoxyaniline

16. Anaesthin

17. Anestezin

18. Anesthesine

19. Anesthone

20. Dermoplast

21. Hurricaine

22. Identhesin

23. Keloform

24. Norcain

25. Topcaine

26. Baby Anbesol

27. Anaesthan-syngala

28. Ora-jel

29. Benzocainum

30. Solu H

31. P-ethoxycarboxylic Aniline

32. 4-carbethoxyaniline

33. Benzoic Acid, 4-amino-, Ethyl Ester

34. P-(ethoxycarbonyl)aniline

35. Ethyl P-aminophenylcarboxylate

36. Dextran Sulfate Sodium

37. 9011-18-1

38. Benzocaina

39. Ethyl Paba

40. 4-(ethoxycarbonyl)aniline

41. P-aminobenzoic Acid Ethyl Ester

42. Aethoform

43. Benzoic Acid, P-amino-, Ethyl Ester

44. Ethyl4-aminobenzoate

45. 4-aminobenzoic Acid, Ethyl Ester

46. 4-amino-benzoic Acid Ethyl Ester

47. Ethylester Kyseliny P-aminobenzoove

48. Ethyl-p-aminobenzoate

49. Flavamed

50. Subcutin

51. P-aminobenzoic Acid, Ethyl Ester

52. Chebi:116735

53. Nsc-4688

54. Mfcd00007892

55. Nsc-41531

56. U3rsy48jw5

57. Ar01

58. 4-aminobenzoic Acid-ethyl Ester

59. Anaesthesinum

60. Ethoforme

61. Norcainum

62. Ar-01

63. Ethylis Aminobenzoas

64. Cas-94-09-7

65. Ncgc00016352-01

66. Anestezin [russian]

67. Chloraseptic

68. Dextran Sulfate Sodium Salt

69. Otocain

70. Outgro

71. Dsstox_cid_1804

72. Wln: Zr Dvo2

73. Dsstox_rid_76338

74. Aethylium Paraminobenzoicum

75. Benzocainum [inn-latin]

76. Dsstox_gsid_21804

77. Benzocaina [inn-spanish]

78. Ethyl Aminobenzoate (van)

79. Caswell No. 430a

80. Finafta

81. Parathesin (tn)

82. Smr000059025

83. Ethylaminobenzoate-4

84. H-4-abz-oet

85. Hsdb 7225

86. Ethylester Kyseliny P-aminobenzoove [czech]

87. Benzocaine (usp/inn)

88. Sr-05000001573

89. Einecs 202-303-5

90. Nsc 41531

91. P-aminobenzoic Ethyl Ester

92. Unii-u3rsy48jw5

93. Epa Pesticide Chemical Code 097001

94. Brn 0638434

95. Benzoak

96. Benzocaine [usp:inn:ban]

97. Vagisil

98. Ai3-02081

99. Benzocaine Usp

100. Diet Ayds

101. Orabase-b

102. Slim Mint Gum

103. Prestwick_991

104. 4-carboethoxyaniline

105. Ethyl 4aminobenzoate

106. Ethyl 4-aminobenzate

107. Ethyl 4-aminobezoate

108. Outgro (salt/mix)

109. Anbesol (salt/mix)

110. Vagisil (salt/mix)

111. Ethyl-4-aminobenzoate

112. P-ethoxycarbonylaniline

113. 4-ethoxycarbonylaniline

114. Ethyl P-amino-benzoate

115. Ethyl-p-amino-benzoate

116. Ethyl Aminobenzoic Acid

117. Cough-x (salt/mix)

118. Spectrum_000074

119. Ethyl 4-amino-benzoate

120. Benzocaine [mi]

121. Ethyl 4-(amino)benzoate

122. Benzocaine [inn]

123. Ethyl P-aminobenzoic Acid

124. Prestwick0_000712

125. Prestwick1_000712

126. Prestwick2_000712

127. Prestwick3_000712

128. Spectrum2_000117

129. Spectrum3_000314

130. Spectrum4_000249

131. Spectrum5_000860

132. Benzocaine [hsdb]

133. Ethyl 4-aminobenzoic Acid

134. Benzocaine [vandf]

135. Epitope Id:114084

136. Ethyl Paba [inci]

137. Benzocaine [mart.]

138. Benzocaine [usp-rs]

139. Benzocaine [who-dd]

140. Benzocaine [who-ip]

141. Sampl3, G4

142. Ethyl Aminobenzoate (jp17)

143. Oprea1_750694

144. Oprea1_827402

145. Schembl25100

146. Bspbio_000923

147. Bspbio_001908

148. Kbiogr_000658

149. Kbioss_000474

150. 4-(ethoxycarbonyl)phenylamine

151. 4-14-00-01129 (beilstein Handbook Reference)

152. Ae-562/40377256

153. Mls001331704

154. Mls002153970

155. Divk1c_000932

156. Ethyl 4-aminobenzoate, 98%

157. Spectrum1500139

158. (p-(ethoxycarbonyl)phenylamine

159. Ethyl P-aminobenzenecarboxylate

160. Spbio_000134

161. Spbio_002844

162. Bpbio1_001017

163. Chembl278172

164. Dtxsid8021804

165. Dextran Sulfate Sodium (dst-h)

166. Ethyl Para Amino Benzoate

167. Hms502o14

168. Kbio1_000932

169. Kbio2_000474

170. Kbio2_003042

171. Kbio2_005610

172. Kbio3_001408

173. P-amino Benzoic Acid Ethyl Ester

174. 4-amino Benzoic Acid Ethyl Ester

175. Benzocaine [ep Monograph]

176. Ethyl Aminobenzoate [jan]

177. Nsc4688

178. Dextran Sulfate Sodium (kmds-h)

179. Ninds_000932

180. Bdbm197282

181. Benzocaine [usp Monograph]

182. Dextran Sulfate Sodium (ds-m-1)

183. Hms1570o05

184. Hms1920g09

185. Hms2091m11

186. Hms2097o05

187. Hms2233h21

188. Hms3371d08

189. Hms3652h13

190. Hms3714o05

191. Hms3885b11

192. Pharmakon1600-01500139

193. Benzocainum [who-ip Latin]

194. Component Of Tympagesic (salt/mix)

195. Cs-b0934

196. Hy-y0258

197. Nsc41531

198. Str01509

199. Tox21_110391

200. Tox21_301149

201. Ccg-38918

202. Nsc755909

203. S4210

204. Stk043620

205. Zinc12358719

206. Akos000119763

207. Benzocaine 1.0 Mg/ml In Acetonitrile

208. Benzocaine 100 Microg/ml In Methanol

209. Tox21_110391_1

210. Ac-8127

211. Db01086

212. Dextran, Hydrogen Sulfate, Sodium Salt

213. Nsc-755909

214. Idi1_000932

215. Benzocaine, Purum, >=99.0% (hplc)

216. Benzocaine, Tested According To Ph.eur.

217. Ncgc00016352-02

218. Ncgc00016352-03

219. Ncgc00016352-04

220. Ncgc00016352-07

221. Ncgc00094598-01

222. Ncgc00094598-02

223. Ncgc00255047-01

224. Ethyl 4-aminobenzoate, 98.0-101.0%

225. Sbi-0051293.p003

226. Component Of Solarcaine Aerosol (salt/mix)

227. A0271

228. Ab00051923

229. Bb 0258778

230. Ft-0624536

231. Ft-0625762

232. Ft-0662548

233. Sw197074-3

234. A14560

235. C07527

236. D00552

237. Ab00051923_09

238. Ab00051923_10

239. Component Of Anbesol Maximum Strength (salt/mix)

240. A860898

241. A930377

242. Aminobenzoic Acid Impurity B [ep Impurity]

243. Q422745

244. Ethyl 4-aminobenzoate, Saj First Grade, >=99.0%

245. Q-200688

246. Sr-05000001573-1

247. Sr-05000001573-3

248. Brd-k75466013-001-05-2

249. Brd-k75466013-001-08-6

250. Ethyl 4-aminobenzoate, Vetec(tm) Reagent Grade, 98%

251. F2190-0448

252. 4-aminobenzoic Acid-ethyl Ester 1000 Microg/ml In Methanol

253. Benzocaine, European Pharmacopoeia (ep) Reference Standard

254. Benzocaine, United States Pharmacopeia (usp) Reference Standard

255. Benzocaine, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₉H₁₁NO₂
Molecular Weight	165.19 g/mol
XLogP3	1.9
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	165.078978594 g/mol
Monoisotopic Mass	165.078978594 g/mol
Topological Polar Surface Area	52.3 Å²
Heavy Atom Count	12
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

4 Drug and Medication Information

4.1 Therapeutic Uses

Indicated for the relief of: canker sores, cold sores, or fever blisters: benzocaine (gel and topical solution); gingival or oral mucosal pain (i.e., pain caused by mouth or gum irritation, inflammation, lesions, or minor dental procedures): benzocaine (gel, dental paste, lozenges, and topical solution); dental prosthetic pain (i.e., pain or irritation caused by dentures or other dental or orthodontic appliances): benzocaine (dental paste, gel ointment, and topical solution); teething pain: benzocaine (7.5% and 10% gel); and toothache: benzocaine (10% and 20% gel and topical solution).

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 153

Indicated to suppress the gag reflex and/or other laryngeal and esophageal reflexes to facilitate dental examination or procedures (including oral surgery), endoscopy, or intubation: benzocaine (gel, topical aerosol, and topical solution). /Included in US product labeling/

Indicated to provide topical anesthesia of accessible mucous membranes prior to examination, endoscopy or instrumentation, or other procedures involving the: esophagus: benzocaine (gel and topical solution)); larynx: benzocaine (gel and topical solution); mouth, In dental procedures and oral surgery: benzocaine (gel, topical aerosol, and topical solution); nasal cavity: benzocaine (gel); pharynx or throat: benzocaine (gel, topical aerosol, and topical solution); rectum: benzocaine (gel); respiratory tract or trachea: benzocaine (gel, topical aerosol, and topical solution); urinary tract: benzocaine (gel); and vagina: benzocaine (gel).

Anesthetic (local).

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 186

(VET): Local (usually surface) anesthetic.

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 186

4.2 Drug Warning

Infants and the elderly were more likely to develop toxic methemoglobinemia after benzocaine exposure. Other risk factors included genetic reductase deficiencies, exposure to high doses of anesthetic, and presence of denuded skin and mucous membranes. Because of the potential for severe complications, methemoglobinemia should be corrected promptly in compromised patients and those with toxic benzocaine concentrations. The possibility of masking symptoms during general anesthesia carries special risk of use of this agent in the preanesthesia setting.

PMID:8069004 Rodriguez LF et al; Ann Pharmacother 28 (5): 643-9 (1994)

Use of otic anesthetics may mask symptoms of a fulminating middle ear infection (acute otitis media). Otic solutions containing benzocaine should not be used in the presence of a perforated tympanic membrane.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2695

When applied topically as recommended, benzocaine is relatively nontoxic, however, sensitization may occur.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3411

When used as a male genital desensitizer, benzocaine generally does not adversely affect orgasm in female sexual partners and does not appear to anesthetize the clitoris or vagina.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3411

For more Drug Warnings (Complete) data for BENZOCAINE (9 total), please visit the HSDB record page.

4.3 Drug Indication

Benzocaine is indicated for local anesthesia in dentistry, minor trauma, and as preparation for infiltrative anesthesia. Benzocaine products are indicated for topical anesthesia in a wide variety of conditions including skin irritation, oral pain, and hemorrhoids.

Treatment of oropharyngeal pain

5 Pharmacology and Biochemistry

5.1 Pharmacology

Benzocaine is indicated for use as a topical anesthetic. It has a duration of action of approximately 10 minutes and a wide therapeutic window. Patients should be counselled regarding the risks of methemoglobinemia.

5.2 MeSH Pharmacological Classification

Anesthetics, Local

Drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They act on any part of the nervous system and on every type of nerve fiber. In contact with a nerve trunk, these anesthetics can cause both sensory and motor paralysis in the innervated area. Their action is completely reversible. (From Gilman AG, et. al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed) Nearly all local anesthetics act by reducing the tendency of voltage-dependent sodium channels to activate. (See all compounds classified as Anesthetics, Local.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

BENZOCAINE

5.3.2 FDA UNII

U3RSY48JW5

5.3.3 Pharmacological Classes

Cell-mediated Immunity [PE]; Copper Absorption Inhibitor [EPC]; Decreased Copper Ion Absorption [PE]; Increased Histamine Release [PE]; Sigma-1 Agonist [EPC]; Sigma-1 Receptor Agonists [MoA]; Skin Barrier Activity [PE]; Standardized Chemical Allergen [EPC]; Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]; Uncompetitive NMDA Receptor Antagonists [MoA]; Allergens [CS]

5.4 ATC Code

C05AD03

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

C - Cardiovascular system

C05 - Vasoprotectives

C05A - Agents for treatment of hemorrhoids and anal fissures for topical use

C05AD - Local anesthetics

C05AD03 - Benzocaine

D - Dermatologicals

D04 - Antipruritics, incl. antihistamines, anesthetics, etc.

D04A - Antipruritics, incl. antihistamines, anesthetics, etc.

D04AB - Anesthetics for topical use

D04AB04 - Benzocaine

N - Nervous system

N01 - Anesthetics

N01B - Anesthetics, local

N01BA - Esters of aminobenzoic acid

N01BA05 - Benzocaine

R - Respiratory system

R02 - Throat preparations

R02A - Throat preparations

R02AD - Anesthetics, local

R02AD01 - Benzocaine

5.5 Absorption, Distribution and Excretion

Branchial and urinary elimination of benzocaine residues was evaluated in adult rainbow trout, Oncorhynchus mykiss, given a single dorsal aortic dose of 14(C)-benzocaine hydrochloride. Branchial elimination of benzocaine residues was rapid and accounted for 59.2% of the dose during the first 3 h after dosing. Renal elimination of radioactivity was considerably slower; the kidney excreted 2.7% dose within 3 h and 9.0% within 24 hr. Gallbladder bile contained 2.0% dose 24 hr after injection. Of the radioactivity in radiochromatograms from water taken 3 min after injection, 87.3% was benzocaine and 12.7% was N-acetylated benzocaine. After 60 min, 32.7% was benzocaine and 67.3% was N-acetylated benzocaine. Of the radioactivity in radiochromatograms from urine taken 1 hr after dosing, 7.6% was para-aminobenzoic acid, 59.7% was N-acetylated para-aminobenzoic acid, 19.5% was benzocaine, and 8.0% was N-acetylated benzocaine. The proportion of the radioactivity in urine changed with time so that by 20 hr, 1.0% was para-aminobenzoic acid and 96.6% was N-acetylated para-aminobenzoic acid. Benzocaine and a more hydrophobic metabolite, N-acetylated benzocaine, were eliminated primarily through the gills; renal and biliary pathways were less significant elimination routes for benzocaine residues.

PMID:1897251 Meinertz JR et al; Xenobiotica 21 (4): 525-33 (1991)

5.6 Metabolism/Metabolites

Benzocaine undergoes ester hydrolysis to form 4-aminobenzoic acid, acetylation to form acetylbenzocaine, or N-hydroxylation to form benzocaine hydroxide. 4-aminobenzoic acid can be acetylated or acetylbenzocaine can undergo ester hydrolysis to form 4-acetaminobenzoic acid.

The effect of dose and enzymatic inhibition on the percutaneous absorption and metabolism of benzocaine was studied in vitro in the hairless guinea pig. At the dose level of 2 ug/sq cm, benzocaine was rapidly absorbed and extensively metabolized (80%) by acetyltransferase. As the applied dose of benzocaine was increased to 40 and 200 ug/sq cm, N-acetylation of benzocaine decreased to 44 and 34%, respectively, suggesting saturation of the acetyltransferase system. Total 14(C) absorption after benzocaine application was not significantly different between control and enzyme-inhibited skin and therefore does not appear to be affected by the extent of benzocaine metabolism during percutaneous penetration. Skin provides a significant first-pass metabolic effect for therapeutic doses of percutaneously absorbed benzocaine, and the primary metabolite formed, acetylbenzocaine, is biologically active.

PMID:8737920 Kraeling ME et al; Skin Pharmacol 9 (3): 221-30 (1996)

5.7 Mechanism of Action

Benzocaine diffuses into nerve cells where it binds to sodium channels, preventing the channels from opening, and blocking the influx of sodium ions. Nerve cells unable to allow sodium into cells cannot depolarize and conduct nerve impulses.

Benzocaine reversibly stabilizes the neuronal membrane with decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.

Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 1130

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LGM Pharma

U.S.A

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

PharmaVenue

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

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

03

Rochem International Inc

U.S.A

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

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

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

04

Chynops Pharma

India

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

iPHEX India

Attending

Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.

Contact Supplier

India

Virtual Booth

Digital Content

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

05

Atman Pharmaceuticals

India

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

PharmaVenue

Not Confirmed

Atman Pharmaceuticals: A One Stop Solution Provider to All Your API Needs.

Contact Supplier

India

Virtual Booth

Digital Content

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

Corporate PDF

06

APEX HEALTHCARE LIMITED

India

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

PharmaVenue

Not Confirmed

07

Chongqing Southwest No.2 Pharma. F...

China

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

PharmaVenue

Not Confirmed

08

Jinzhou Jiutai Pharmaceutical

China

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

PharmaVenue

Not Confirmed

09

APEX HEALTHCARE LIMITED

India

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

PharmaVenue

Not Confirmed

10

Archimica

Italy

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

PharmaVenue

Not Confirmed

Only 10 entries up to this point, click to access all

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USDMF

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CEP/COS

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JDMF

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EU WC

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NDC API

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Listed Suppliers

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API Reference Price

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","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"58","totalValueFC":"582.5","currency":"USD","unitRateINR":"4848.8","date":"22-Dec-2023","totalValueINR":"48488","totalValueInUsd":"582.5","indian_port":"JNPT","hs_no":"29214290","bill_no":"9353117","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703183400,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"58","totalValueFC":"582.5","currency":"USD","unitRateINR":"4848.8","date":"22-Dec-2023","totalValueINR":"48488","totalValueInUsd":"582.5","indian_port":"JNPT","hs_no":"29214290","bill_no":"9354469","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703183400,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"58","totalValueFC":"1456.2","currency":"USD","unitRateINR":"4848.8","date":"22-Dec-2023","totalValueINR":"121220","totalValueInUsd":"1456.2","indian_port":"JNPT","hs_no":"29214290","bill_no":"9353046","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703183400,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"58","totalValueFC":"1456.2","currency":"USD","unitRateINR":"4848.8","date":"22-Dec-2023","totalValueINR":"121220","totalValueInUsd":"1456.2","indian_port":"JNPT","hs_no":"29214290","bill_no":"9353980","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703183400,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"120.00","actualQuantity":"120","unit":"KGS","unitRateFc":"58","totalValueFC":"6989.8","currency":"USD","unitRateINR":"4848.8","date":"22-Dec-2023","totalValueINR":"581856","totalValueInUsd":"6989.8","indian_port":"JNPT","hs_no":"29214290","bill_no":"9353004","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710700200,"product":"BENZOCAINE EP\/USP 100KG (PACKED IN 20KG FIBER DRUMS) BATCH:C0032309001 (FOR MFG OF RUBBER CONTRACEPTIVES)","address":"74-91, KIADB INDUISTRIAL ESTATE,","city":"BANGALORE, KARNATAKA","supplier":"DELSOL PRODUCTS LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SURETEX PROPHYLACTICS INDIA ","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"76.1","totalValueFC":"9833","currency":"GBP","unitRateINR":"8164.9","date":"18-Mar-2024","totalValueINR":"816494.25","totalValueInUsd":"9833","indian_port":"Bangalore Air","hs_no":"29163150","bill_no":"2625511","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"7 TREBECK STREETLONDON, ENGLAND,W1J7LU. DELSOL@DELSOLPRODUCTS.COM GB","customerAddress":"74-91, KIADB INDUISTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712773800,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"130.00","actualQuantity":"130","unit":"KGS","unitRateFc":"56","totalValueFC":"7301.2","currency":"USD","unitRateINR":"4690","date":"11-Apr-2024","totalValueINR":"609700","totalValueInUsd":"7301.2","indian_port":"JNPT","hs_no":"29214290","bill_no":"2971205","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712773800,"product":"BENZOCAINE (QTY:1 X 500 MG, VALUE: USD 273) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"USP","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0005","unit":"KGS","unitRateFc":"546000","totalValueFC":"281.7","currency":"USD","unitRateINR":"47041240","date":"11-Apr-2024","totalValueINR":"23520.62","totalValueInUsd":"281.7","indian_port":"Hyderabad Air","hs_no":"29224990","bill_no":"2979217","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD 21704 USA Frederick, , United States United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712860200,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"56","totalValueFC":"1404.1","currency":"USD","unitRateINR":"4690","date":"12-Apr-2024","totalValueINR":"117250","totalValueInUsd":"1404.1","indian_port":"JNPT","hs_no":"29214290","bill_no":"2984176","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724178600,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"56","totalValueFC":"559.1","currency":"USD","unitRateINR":"4690","date":"21-Aug-2024","totalValueINR":"46900","totalValueInUsd":"559.1","indian_port":"JNPT","hs_no":"29214290","bill_no":"5172576","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724178600,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"56","totalValueFC":"1118.3","currency":"USD","unitRateINR":"4690","date":"21-Aug-2024","totalValueINR":"93800","totalValueInUsd":"1118.3","indian_port":"JNPT","hs_no":"29214290","bill_no":"5172580","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724178600,"product":"BENZOCAINE EP","address":"NEELAM CENTRE, B WING, 4TH FLOOR","city":"MUMBAI,MAHARASHTRA","supplier":"CHANGZHOU SUNCHEM PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"45.00","actualQuantity":"45","unit":"KGS","unitRateFc":"56","totalValueFC":"2516.1","currency":"USD","unitRateINR":"4690","date":"21-Aug-2024","totalValueINR":"211050","totalValueInUsd":"2516.1","indian_port":"JNPT","hs_no":"29214290","bill_no":"5170891","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"EMICAL MATERIAL CO., LTD.JIULI STREET, BENNIU TOWN, CHANGZHOU CITY,JIANGSU PROVINCE,213134 CHINA","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR"}]

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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INTERMEDIATES SUPPLIERS

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ANALYTICAL

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Analytical Methods

ABOUT THIS PAGE

Benzocaine Manufacturers

A Benzocaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzocaine, including repackagers and relabelers. The FDA regulates Benzocaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzocaine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Benzocaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Benzocaine Suppliers

A Benzocaine supplier is an individual or a company that provides Benzocaine active pharmaceutical ingredient (API) or Benzocaine finished formulations upon request. The Benzocaine suppliers may include Benzocaine API manufacturers, exporters, distributors and traders.

click here to find a list of Benzocaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Benzocaine USDMF

A Benzocaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzocaine active pharmaceutical ingredient (API) in detail. Different forms of Benzocaine DMFs exist exist since differing nations have different regulations, such as Benzocaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Benzocaine DMF submitted to regulatory agencies in the US is known as a USDMF. Benzocaine USDMF includes data on Benzocaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzocaine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Benzocaine suppliers with USDMF on PharmaCompass.

Benzocaine JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Benzocaine Drug Master File in Japan (Benzocaine JDMF) empowers Benzocaine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Benzocaine JDMF during the approval evaluation for pharmaceutical products. At the time of Benzocaine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Benzocaine suppliers with JDMF on PharmaCompass.

Benzocaine CEP

A Benzocaine CEP of the European Pharmacopoeia monograph is often referred to as a Benzocaine Certificate of Suitability (COS). The purpose of a Benzocaine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Benzocaine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Benzocaine to their clients by showing that a Benzocaine CEP has been issued for it. The manufacturer submits a Benzocaine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Benzocaine CEP holder for the record. Additionally, the data presented in the Benzocaine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Benzocaine DMF.

A Benzocaine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benzocaine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Benzocaine suppliers with CEP (COS) on PharmaCompass.

Benzocaine WC

A Benzocaine written confirmation (Benzocaine WC) is an official document issued by a regulatory agency to a Benzocaine manufacturer, verifying that the manufacturing facility of a Benzocaine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benzocaine APIs or Benzocaine finished pharmaceutical products to another nation, regulatory agencies frequently require a Benzocaine WC (written confirmation) as part of the regulatory process.

click here to find a list of Benzocaine suppliers with Written Confirmation (WC) on PharmaCompass.

Benzocaine NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Benzocaine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Benzocaine API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Benzocaine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Benzocaine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Benzocaine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Benzocaine suppliers with NDC on PharmaCompass.

Benzocaine GMP

Benzocaine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Benzocaine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Benzocaine GMP manufacturer or Benzocaine GMP API supplier for your needs.

Benzocaine CoA

A Benzocaine CoA (Certificate of Analysis) is a formal document that attests to Benzocaine's compliance with Benzocaine specifications and serves as a tool for batch-level quality control.

Benzocaine CoA mostly includes findings from lab analyses of a specific batch. For each Benzocaine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Benzocaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzocaine EP), Benzocaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzocaine USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers

11 USDMF

6 CEP/COS

1 JDMF

5 EU WC

19 NDC API

22 Listed Suppliers

$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers

3 Europe

3 Canada

34 South Africa

8 Listed Dossiers

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EXCIPIENTS BY APPLICATIONS

84 Fillers, Diluents & Binders

78 Topical

59 Solubilizers

51 Thickeners and Stabilizers

44 Taste Masking

39 Parenteral