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Chemistry

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Also known as: 4-aminobenzenesulfonamide, 63-74-1, Sulphanilamide, Sulfamine, P-aminobenzenesulfonamide, Sulphonamide
Molecular Formula
C6H8N2O2S
Molecular Weight
172.21  g/mol
InChI Key
FDDDEECHVMSUSB-UHFFFAOYSA-N
FDA UNII
21240MF57M

Sulfanilamide
A short-acting sulfonamide used as an anti-infective agent. It has lower anti-bacterial activity than SULFAMETHOXAZOLE.
1 2D Structure

Sulfanilamide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-aminobenzenesulfonamide
2.1.2 InChI
InChI=1S/C6H8N2O2S/c7-5-1-3-6(4-2-5)11(8,9)10/h1-4H,7H2,(H2,8,9,10)
2.1.3 InChI Key
FDDDEECHVMSUSB-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC(=CC=C1N)S(=O)(=O)N
2.2 Other Identifiers
2.2.1 UNII
21240MF57M
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4 Aminobenzenesulfonamide

2. 4-aminobenzenesulfonamide

3. Azol Polvo

4. Sulfanilamide Barium Salt

5. Sulfanilamide Cadmium Salt

6. Sulfanilamide Hydrochloride

7. Sulfanilamide Lithium Salt

8. Sulfanilamide Magnesium Salt

9. Sulfanilamide Monohydrate

10. Sulfanilamide Silver Salt

11. Sulfanilamide Sodium

12. Sulfanilamide Sodium Salt

13. Sulfanilamide Strontium Salt

14. Sulfanilamide Zinc Salt

15. Sulphanilamide

2.3.2 Depositor-Supplied Synonyms

1. 4-aminobenzenesulfonamide

2. 63-74-1

3. Sulphanilamide

4. Sulfamine

5. P-aminobenzenesulfonamide

6. Sulphonamide

7. Sulfonylamide

8. P-aminobenzenesulfamide

9. Prontylin

10. Prontosil Album

11. 4-aminobenzene-1-sulfonamide

12. Bacteramid

13. Streptasol

14. Streptocid

15. P-sulfamoylaniline

16. Sulfonamide P

17. Prontosil I

18. Benzenesulfonamide, 4-amino-

19. Estreptocida

20. Exoseptoplix

21. Streptoclase

22. P-sulfamidoaniline

23. Sulfamidyl

24. Sulfanalone

25. Sulfanidyl

26. Sulfanil

27. Sulfocidine

28. Sulfana

29. 4-sulfamoylaniline

30. Sulfanilimidic Acid

31. P-anilinesulfonamide

32. P-aminophenylsulfonamide

33. Ambeside

34. Antistrept

35. Astreptine

36. Astrocid

37. Bactesid

38. Collomide

39. Colsulanyde

40. Copticide

41. Deseptyl

42. Ergaseptine

43. Erysipan

44. Gombardol

45. Lysococcine

46. Neococcyl

47. Orgaseptine

48. Prontalbin

49. Proseptal

50. Proseptine

51. Proseptol

52. Pysococcine

53. Septanilam

54. Septinal

55. Septolix

56. Septoplex

57. Septoplix

58. Strepamide

59. Strepsan

60. Streptagol

61. Streptamid

62. Streptamin

63. Streptocide

64. Streptocom

65. Strepton

66. Streptopan

67. Streptosil

68. Streptozol

69. Streptozone

70. Streptrocide

71. Sulfocidin

72. Therapol

73. Albexan

74. Albosal

75. Dipron

76. Gerison

77. Infepan

78. Sanamid

79. Stramid

80. Tolder

81. Lusil

82. Prontosil White

83. Pronzin Album

84. Septamide Album

85. Stopton Album

86. Streptocid Album

87. 4-aminophenylsulfonamide

88. Rubiazol A

89. White Streptocide

90. Pabs

91. Streptocide White

92. P-aminobenzenesulfonylamide

93. Aniline-p-sulfonic Amide

94. Fourneau 1162

95. Sulfanilamide Vaginal Cream

96. Benzenesulfonamide, P-amino-

97. 4-azanylbenzenesulfonamide

98. 4-amino-benzenesulfonamide

99. Mfcd00007939

100. P-aminobenzensulfonamide

101. Sulphanilamidum

102. 1162 F

103. 4-(aminosulfonyl)aniline

104. Para-aminobenzenesulfonamide

105. A-349

106. F 1162

107. Chebi:45373

108. 4-aminobenzene Sulfonic Acid Amide

109. Nsc-7618

110. Chembl21

111. P-amino Benzene Sulfonamide

112. (4-(aminosulfonyl)phenyl)amine

113. Avc

114. Streptocidum

115. Nsc7618

116. Sulfanilamide Melting Point Standard

117. Sulfanilamide (inn)

118. 21240mf57m

119. Cas-63-74-1

120. Ncgc00016285-02

121. Ncgc00016285-05

122. Sulfanilamida

123. Sulfanilamidum

124. 4-aminobenzenesulphonamide (sulphanilamide)

125. Sulfanilamide, >=99%

126. Dsstox_cid_3622

127. Sulfanilamide [inn]

128. Dsstox_rid_77115

129. Dsstox_gsid_23622

130. Streptocide (van)

131. Solfanilamide [dcit]

132. Caswell No. 809a

133. Solfanilamide

134. Hsdb 223

135. Sulfanilamidum [inn-latin]

136. Sulfanilamida [inn-spanish]

137. Smr000059035

138. Ccris 764

139. Sr-01000763435

140. Nsc 7618

141. Einecs 200-563-4

142. Epa Pesticide Chemical Code 077902

143. Brn 0511852

144. Sulfanilamine

145. Sulfanimide

146. Sulfanilamide [inn:dcf:nf]

147. Ai3-00952

148. Sulphanilic Amide

149. 4-sulphanilamide

150. Unii-21240mf57m

151. Sulfanimide,(s)

152. F-1162

153. Streptocid (tn)

154. Delta-sulfanilamide

155. Prestwick_36

156. 4-sulfamoyl-aniline

157. Sulfanilamide Reagent

158. Sulfanilamide-reagent

159. 4-sulphamoyl Aniline

160. Spectrum_000489

161. 4-aminobenzensulfonamide

162. Wln: Zswr Dz

163. 4-aminobenzenesulphonamide

164. P-aminobenzene Sulfonamide

165. Prestwick0_000729

166. Prestwick1_000729

167. Prestwick2_000729

168. Prestwick3_000729

169. Spectrum2_000846

170. Spectrum3_001406

171. Spectrum4_000398

172. Spectrum5_001081

173. 4-aminobenzene Sulfonamide

174. 4-aminobenzene-sulfonamide

175. P-aminosulfonyl Phenylamine

176. Schembl740

177. Sulfanilamide [mi]

178. 4-amino-benzenesulphonamide

179. Epitope Id:122232

180. Avc (tn)

181. Sulfanilamide [hsdb]

182. Oprea1_273157

183. P-aminobenzene Sulfonyl Amide

184. Bspbio_000658

185. Bspbio_003052

186. Kbiogr_000955

187. Kbioss_000969

188. Sulfanilamide [vandf]

189. 4-14-00-02658 (beilstein Handbook Reference)

190. Mls001074682

191. Mls002152940

192. Bidd:gt0170

193. Divk1c_000528

194. Spectrum1500646

195. Sulfanilamide [mart.]

196. Sulphanilamidum [hpus]

197. Spbio_000831

198. Spbio_002597

199. Sulfanilamide [usp-rs]

200. Sulfanilamide [who-dd]

201. Aromatic Sulfonamide Compound 5

202. Bpbio1_000724

203. Halogenosulfanilamide Deriv. 5a

204. Zinc2101

205. Dtxsid4023622

206. Schembl11880061

207. Bdbm10857

208. Hms501k10

209. Kbio1_000528

210. Kbio2_000969

211. Kbio2_003537

212. Kbio2_006105

213. Kbio3_002272

214. Sulfanilamide, P.a., 99.0%

215. Ninds_000528

216. Hms1570a20

217. Hms1921o07

218. Hms2092e20

219. Hms2097a20

220. Hms2233b19

221. Hms3370j16

222. Hms3655k19

223. Hms3714a20

224. Hms3744m13

225. Pharmakon1600-01500646

226. Ro13354

227. Sulfanilamide [orange Book]

228. Hy-b0242

229. Sulfanilamide [ep Monograph]

230. Tox21_110351

231. Tox21_201331

232. Tox21_303336

233. Ac9456

234. Aromatic/heteroaromatic Sulfonamide 2

235. Bbl005257

236. C1264

237. Ccg-40302

238. Nsc757404

239. S1685

240. Stk298902

241. Uk-124

242. Akos000119305

243. Tox21_110351_1

244. Db00259

245. Nsc-757404

246. Idi1_000528

247. Ncgc00016285-01

248. Ncgc00016285-03

249. Ncgc00016285-04

250. Ncgc00016285-06

251. Ncgc00016285-08

252. Ncgc00091144-01

253. Ncgc00091144-02

254. Ncgc00091144-03

255. Ncgc00257174-01

256. Ncgc00258883-01

257. Sulfanilamide 100 Microg/ml In Methanol

258. As-13239

259. Bp-12552

260. Sulfanilamide (4-aminobenzenesulfonamide)

261. Sy009959

262. Sbi-0051575.p002

263. Ab00052138

264. Ft-0657032

265. Ft-0674702

266. S0381

267. Sulfadiazine Impurity D [ep Impurity]

268. Sw196353-3

269. Sulfadimidine Impurity D [ep Impurity]

270. Sulfanilamide, Jis Special Grade, >=99.7%

271. Sulfanilamide, Vetec(tm) Reagent Grade, 97%

272. C07458

273. D08543

274. Ab00052138-10

275. Ab00052138_11

276. Ab00052138_12

277. Sulfadimethoxine Impurity E [ep Impurity]

278. Sulfamethoxazole Impurity E [ep Impurity]

279. A834498

280. Ac-907/25014139

281. Q423423

282. Sulfanilamide, Vetranal(tm), Analytical Standard

283. Sr-01000763435-2

284. Sr-01000763435-3

285. Sr-01000763435-4

286. Sulfacetamide Sodium Impurity A [ep Impurity]

287. Sulfanilamide (166 Degrees C) Melting Point Standard

288. F2190-0451

289. Benzenesulfonic Acid,4-amino,amide Sulfanilamide

290. Ethyl1-(aminomethyl)-6,8-dimethoxyisoquinoline-4-carboxylate

291. Sulfanilamide, European Pharmacopoeia (ep) Reference Standard

292. Sulfanilamide, Puriss. P.a., >=99% (calc. To The Dried Substance)

293. Sulfanilamide, United States Pharmacopeia (usp) Reference Standard

294. Reagecon Melting Point Sulphanilamide +164 To +166 Degrees C Standard

295. Sulfadimethoxine Sodium For Veterinary Use Impurity E [ep Impurity]

296. Sulfanilamide Melting Point Standard, United States Pharmacopeia (usp) Reference Standard

297. 1337-39-9

298. Sulfanilamide Melting Point Standard, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 172.21 g/mol
Molecular Formula C6H8N2O2S
XLogP3-0.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count1
Exact Mass172.03064868 g/mol
Monoisotopic Mass172.03064868 g/mol
Topological Polar Surface Area94.6 Ų
Heavy Atom Count11
Formal Charge0
Complexity211
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 Drug Information
1 of 2  
Drug NameAvc
PubMed HealthSulfanilamide (Vaginal)
Drug ClassesAntibacterial
Drug LabelAVC is a preparation for vaginal administration for the treatment of Candida albicans infections and available in the following forms:AVC CreamEach tube contains:Sulfanilamide...........................................................................
Active IngredientSulfanilamide
Dosage FormCream
RouteVaginal
Strength15%
Market StatusPrescription
CompanyMeda Pharms

2 of 2  
Drug NameAvc
PubMed HealthSulfanilamide (Vaginal)
Drug ClassesAntibacterial
Drug LabelAVC is a preparation for vaginal administration for the treatment of Candida albicans infections and available in the following forms:AVC CreamEach tube contains:Sulfanilamide...........................................................................
Active IngredientSulfanilamide
Dosage FormCream
RouteVaginal
Strength15%
Market StatusPrescription
CompanyMeda Pharms

4.2 Therapeutic Uses

The US FDA announced on May 31, 1979, that their Anti-infective and Topical Drugs Advisory Committee and Fertility and Maternal Health Advisory Committee, as well as other studies, had concluded there was no adequate evidence that the then-available vaginal sulfonamides formulations were effective either for the treatment of vulvovaginitis caused by Candida albicans, Trichomonas vaginalis, or Gardnerella vaginalis (Hemophilus vaginalis) or for relief of the symptoms of these conditions. /Sulfonamides (vaginal)/

USP Convention. USPDI - Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 2547


/Applied topically/ for the treatment of vaginitis caused by Garderella (Hemophilus) vaginalis, Trichomonas and Candida

GENNARO. REMINGTON'S PHARM SCI 17TH ED 1985 p.1176


Antibacterial

Budavari, S. (ed.). The Merck Index - Encyclopedia of Chemicals, Drugs and Biologicals. Rahway, NJ: Merck and Co., Inc., 1989., p. 1409


MEDICATION (VET): antimicrobial.

Budavari, S. (ed.). The Merck Index - Encyclopedia of Chemicals, Drugs and Biologicals. Rahway, NJ: Merck and Co., Inc., 1989., p. 1409


4.3 Drug Warning

VET: INSURE ADEQUATE FLUID INTAKE. USE CAUTIOUSLY IN RENAL DISEASE.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 573


.../IN ONE OF 2 CASES/ A NEW-BORN CHILD BECAME JAUNDICED ON...1ST DAY OF LIFE & DIED ON 8TH DAY; POST MORTEM REVEALED LIVER NECROSIS & FOCAL NECROSES IN ADRENALS & SPLEEN. SECOND CASE RECOVERED AFTER SEVERE JAUNDICE & ANEMIA, COMMENCING ON 4TH DAY OF LIFE. IN BOTH INSTANCES MOTHER HAD BEEN TREATED WITH SULFANILAMIDE...

The Chemical Society. Foreign Compound Metabolism in Mammals Volume 3. London: The Chemical Society, 1975., p. 671


Sulfonamides are absorbed from the vaginal mucosa and are distributed into breast milk. Use is not recommended in nursing mothers since sulfonamides may cause hyperbilirubinemia in the infant. In addition, sulfonamides may cause hemolytic anemia in glucose-6-phosphate dehydrogenase-deficient neonates. /Sulfonamides (vaginal)/

USP Convention. USPDI - Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 2548


Side/Adverse Effects: Those indicating need for medical attention: Incidence less frequent: Hypersensitivity (itching, burning, skin rash, redness, swelling, or other sign of irritation not present before therapy). Those indicating need for medical attention only if they continue or are bothersome: Incidence less frequent are: Rash or irritation of penis of sexual partner. /Sulfonamides (vaginal)/

USP Convention. USPDI - Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 2548


For more Drug Warnings (Complete) data for SULFANILAMIDE (6 total), please visit the HSDB record page.


4.4 Minimum/Potential Fatal Human Dose

3. 3= MODERATELY TOXIC: PROBABLE ORAL LETHAL DOSE (HUMAN) 0.5-5 G/KG, BETWEEN 1 OZ & 1 PINT (OR 1 LB) FOR 70 KG PERSON (150 LB).

Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-238


4.5 Drug Indication

For the treatment of vulvovaginitis caused by Candida albicans.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Sulfanilamide is a sulfonamide antibiotic. The sulfonamides are synthetic bacteriostatic antibiotics with a wide spectrum against most gram-positive and many gram-negative organisms. However, many strains of an individual species may be resistant. Sulfonamides inhibit multiplication of bacteria by acting as competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle. Bacterial sensitivity is the same for the various sulfonamides, and resistance to one sulfonamide indicates resistance to all. Most sulfonamides are readily absorbed orally. However, parenteral administration is difficult, since the soluble sulfonamide salts are highly alkaline and irritating to the tissues. The sulfonamides are widely distributed throughout all tissues. High levels are achieved in pleural, peritoneal, synovial, and ocular fluids. Although these drugs are no longer used to treat meningitis, CSF levels are high in meningeal infections. Their antibacterial action is inhibited by pus.


5.2 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


5.3 ATC Code

D - Dermatologicals

D06 - Antibiotics and chemotherapeutics for dermatological use

D06B - Chemotherapeutics for topical use

D06BA - Sulfonamides

D06BA05 - Sulfanilamide


J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01E - Sulfonamides and trimethoprim

J01EB - Short-acting sulfonamides

J01EB06 - Sulfanilamide


5.4 Absorption, Distribution and Excretion

Absorption

Sulfonamides are absorbed through the vaginal mucosa. There are no pharmacokinetic data available describing how much of an intravaginal dose reaches the systemic circulation.


SULFANILAMIDE DIFFUSES INTO ALL TISSUES & SECRETIONS OF BODY, INCL MILK & FETAL PRODUCTS, & CEREBROSPINAL FLUID, IN CONCN APPROX THOSE FOUND IN BLOOD.

Thienes, C., and T.J. Haley. Clinical Toxicology. 5th ed. Philadelphia: Lea and Febiger, 1972., p. 210


ABSORPTION /OF SULFONAMIDES/ FROM SKIN & VAGINA IS ERRATIC. ONCE INTO BLOODSTREAM, SULFONAMIDES BIND TO SERUM ALBUMIN TO VARYING DEGREES... PROTEIN-BINDING LIMITS PENETRANCE INTO TISSUES & GLOMERULAR FILTRATION &...IS DETERMINANT OF DISTRIBUTION & RATE OF EXCRETION. /SULFONAMIDES/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1105


Sulfonamides are eliminated from the body partly as the unchanged drug and partly as metabolic products. The largest fraction is excreted in the urine, and the half life of sulfonamides in the body is thus dependent on renal function. Small amounts are eliminated in the feces and in bile, milk, and other secretions. /Sulfonamides/

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1049


Except for sulfonamides especially designed for their local effects in the bowel, this class of drugs is rapidly absorbed from the gastrointestinal tract. Approximately 70 to 100% of an oral dose is absorbed, and sulfonamide can be found in the urine within 30 minutes of ingestion. The small intestine is the major site of absorption, but some of the drug is absorbed from the stomach. Absorption from other sites, such as the vagina, respiratory tract, or abraded skin, is variable and unreliable, but a sufficient amount may enter the body to cause toxic reactions in susceptible persons or to produce sensitization. /Sulfonamides/

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1049


For more Absorption, Distribution and Excretion (Complete) data for SULFANILAMIDE (8 total), please visit the HSDB record page.


5.5 Metabolism/Metabolites

...DOGS...ACETYLATE SULFAMOYL GROUP & EXCRETE...N1-ACETYLSULFANILAMIDE...

The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 1: A Review of the Literature Published Between 1960 and 1969. London: The Chemical Society, 1970., p. 424


When sulfanilamide, p-aminobenzoic acid, 4-aminobiphenyl, 2-aminofluorene or 1-aminopyrene was given orally to dogs, the corresponding N-acetyl and N-formyl derivatives were isolated from urine or feces. ... Dog intestinal flora and several bacterial strains exhibited both N-acetylating and N-formylating activities, in varying degrees, toward all of the arylamines tested. ... The results /show/ that the intestinal microflora plays an important role in the formation of N-acyl derivatives from arylamines in dogs.

PMID:7834807 Okumura F et al; Carcinogenesis 16 (1): 71-6 (1995)


5.6 Mechanism of Action

Sulfanilamide is a competitive inhibitor of bacterial enzyme dihydropteroate synthetase. This enzyme normally uses para-aminobenzoic acid (PABA) for synthesizing the necessary folic acid. The inhibited reaction is normally necessary in these organisms for the synthesis of folic acid. Without it, bacteria cannot replicate.


Sulfonamides are structural analogs and competitive antagonist of para-aminobenzoic acid ... and thus prevent normal bacterial utilization of para-aminobenzoic acid for the synthesis of folic acid (pteroylglutamic acid). ... More specifically, sulfonamides are competitive inhibitors of dihydropteroate synthase, the bacterial enzyme responsible for the incorporation of para-aminobenzoic acid into dihydropteroic acid, the immediate precursor of folic acid. /Sulfonamides/

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1048


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NO. 8-3-166\/1 & 2\/105 TO 108,,F","city":"ERRAGADDA,TELANGANA","supplier":"N\/A","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"HINDYS LAB PRIVATE LIMITED","customerCountry":"INDIA","quantity":"14000.00","actualQuantity":"14000","unit":"KGS","unitRateFc":"5.4","totalValueFC":"75669.6","currency":"USD","unitRateINR":"451.8","date":"05-Jul-2024","totalValueINR":"6325305","totalValueInUsd":"75669.6","indian_port":"Madras Sea","hs_no":"29359090","bill_no":"4344410","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"N\/A","customerAddress":"H. NO. 8-3-166\/1 & 2\/105 TO 108,,F"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722018600,"product":"SULFANILAMIDE (4-AMINOBENZENE SULFANILAMIDE )","address":"292 PRINCESS STREET","city":"MUMBAI ,MAHARASHTRA","supplier":"RUIYIXIANG HANGZHOU IMP. AND EXP. 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D-20459HAMBURGHAMBURG GERMANY","customerAddress":"292 PRINCESS STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726079400,"product":"INDUSTRIAL SULFANILAMIDE MIN 98%","address":"UNIT NO. 117, RAVI KIRAN 1ST FLOOR","city":"ANDHERI(W) MUMBAI","supplier":"SM TRADEX PTE. LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"DANOPHARM CHEMICALS PRIVATE ","customerCountry":"INDIA","quantity":"17853.00","actualQuantity":"17853","unit":"KGS","unitRateFc":"4.9","totalValueFC":"88807.6","currency":"USD","unitRateINR":"416.9","date":"12-Sep-2024","totalValueINR":"7442183.73","totalValueInUsd":"88807.6","indian_port":"JNPT","hs_no":"29359090","bill_no":"5560325","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"150 BEACH ROAD, 35-00, GATEWAY WEST -189720 SDNF SINGAPORE","customerAddress":"UNIT NO. 117, RAVI KIRAN 1ST FLOOR"}]
16-Jan-2021
12-Sep-2024
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ABOUT THIS PAGE

Sulfanilamide Manufacturers

A Sulfanilamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfanilamide, including repackagers and relabelers. The FDA regulates Sulfanilamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfanilamide 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 Sulfanilamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Sulfanilamide Suppliers

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

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

Sulfanilamide USDMF

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

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

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

Sulfanilamide 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 Sulfanilamide Drug Master File in Japan (Sulfanilamide JDMF) empowers Sulfanilamide 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 Sulfanilamide JDMF during the approval evaluation for pharmaceutical products. At the time of Sulfanilamide 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 Sulfanilamide suppliers with JDMF on PharmaCompass.

Sulfanilamide CEP

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

A Sulfanilamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sulfanilamide 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 Sulfanilamide suppliers with CEP (COS) on PharmaCompass.

Sulfanilamide 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 Sulfanilamide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Sulfanilamide 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 Sulfanilamide 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 Sulfanilamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sulfanilamide NDC to their finished compounded human drug products, they may choose to do so.

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

Sulfanilamide GMP

Sulfanilamide 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 Sulfanilamide 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 Sulfanilamide GMP manufacturer or Sulfanilamide GMP API supplier for your needs.

Sulfanilamide CoA

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

Sulfanilamide CoA mostly includes findings from lab analyses of a specific batch. For each Sulfanilamide 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.

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