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Chemistry

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Also known as: 68-35-9, Sulphadiazine, Sulfapyrimidine, Sulfadiazin, Adiazine, Sulfazine
Molecular Formula
C10H10N4O2S
Molecular Weight
250.28  g/mol
InChI Key
SEEPANYCNGTZFQ-UHFFFAOYSA-N
FDA UNII
0N7609K889

Sulfadiazine
One of the short-acting SULFONAMIDES used in combination with PYRIMETHAMINE to treat toxoplasmosis in patients with acquired immunodeficiency syndrome and in newborns with congenital infections.
Sulfadiazine is a Sulfonamide Antibacterial.
1 2D Structure

Sulfadiazine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-amino-N-pyrimidin-2-ylbenzenesulfonamide
2.1.2 InChI
InChI=1S/C10H10N4O2S/c11-8-2-4-9(5-3-8)17(15,16)14-10-12-6-1-7-13-10/h1-7H,11H2,(H,12,13,14)
2.1.3 InChI Key
SEEPANYCNGTZFQ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CN=C(N=C1)NS(=O)(=O)C2=CC=C(C=C2)N
2.2 Other Identifiers
2.2.1 UNII
0N7609K889
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Sulfadiazine, Zinc

2. Sulfazin

3. Sulfazine

4. Sulphadiazine

5. Zinc Sulfadiazine

2.3.2 Depositor-Supplied Synonyms

1. 68-35-9

2. Sulphadiazine

3. Sulfapyrimidine

4. Sulfadiazin

5. Adiazine

6. Sulfazine

7. Sulfadiazene

8. Adiazin

9. Debenal

10. Pyrimal

11. Liquadiazine

12. Sulfapyrimidin

13. 2-sulfanilamidopyrimidine

14. Coco-diazine

15. Cremodiazine

16. Spofadrizine

17. Theradiazine

18. Cremotres

19. Deltazina

20. Diazolone

21. Eskadiazine

22. Microsulfon

23. Neotrizine

24. Palatrize

25. Piridisir

26. Quadetts

27. Quadramoid

28. Sanodiazine

29. Sterazine

30. Sulfatryl

31. Sulfolex

32. Sulfonsol

33. Terfonyl

34. Trifonamide

35. Truozine

36. Diazin

37. Neazine

38. Pirimal

39. Sulfose

40. Trisem

41. Sulfanilamidopyrimidine

42. Honey Diazine

43. Lipo-levazine

44. Tri-sulfameth

45. Triple Sulfas

46. Lipo-diazine

47. Metha-meridiazine

48. Sulfadiazinum

49. Diazovit

50. Sulfadiazina

51. Sulphadiazine E

52. 4-amino-n-(pyrimidin-2-yl)benzenesulfonamide

53. Sulfapirimidin

54. Di-azo-mul

55. Thi-di-mer

56. 2-sulfanilylaminopyrimidine

57. Benzenesulfonamide, 4-amino-n-2-pyrimidinyl-

58. Codiazine

59. Silvadene

60. Pecta-diazine, Suspension

61. 4-amino-n-pyrimidin-2-ylbenzenesulfonamide

62. Rp 2616

63. Pyrimidine, 2-sulfanilamido-

64. 2-sulfapyrimidine

65. N(1)-2-pyrimidylsulfanilamide

66. N(1)-2-pyrimidinylsulfanilamide

67. 4-amino-n-2-pyrimidinylbenzenesulfonamide

68. N(sup 1)-2-pyrimidinylsulfanilamide

69. 4-amino-n-(pyrimidin-2-yl)benzene-1-sulfonamide

70. Sulfanilamide, N1-2-pyrimidinyl-

71. 4-amino-n-pyrimidin-2-yl-benzenesulfonamide

72. Chebi:9328

73. Sulfanilamide, N(sup 1)-2-pyrimidinyl-

74. 4-amino-n-2-pyrimidinyl-benzenesulfonamide

75. N(sup1)-2-pyrimidylsulfanilamide

76. Sulfanilamide, N1-2(1h)-pyrimidinylidene-

77. Silver Sulfadiazine

78. A-306

79. N(sup1)-2-pyrimidinylsulfanilamide

80. Chembl439

81. S. N. 112

82. Nsc35600

83. Nsc-35600

84. Cas-68-35-9

85. Ncgc00016305-01

86. Solfadiazina

87. Cocodiazine

88. Solfadiazina [dcit]

89. Sulfadiazine 100 Microg/ml In Acetonitrile

90. 0n7609k889

91. 2-sulfanilamidopyrimidin

92. Nsc117870

93. Sulfapyrimidin [german]

94. Sdz

95. Sulfadiazinum [inn-latin]

96. Sulfadiazina [inn-spanish]

97. Sildaflo

98. S.n. 112

99. 2-sulfanilamidopyrimidin [german]

100. A-306 (van)

101. 4-amino-n-(2-pyrimidinyl)benzenesulfonamide

102. A 306

103. Smr000059113

104. Sulfadiazine (tn)

105. N-(2-pyrimidinyl)sulfanilamide

106. Rbpi21 & Sulfa

107. Rp-2616

108. Sr-01000002973

109. Ssd

110. Einecs 200-685-8

111. Mfcd00006065

112. Nsc 35600

113. 2-sulfanilamido-pyrimidine

114. Brn 0235192

115. Diazine

116. Crl-8131 & Sulfadiazine

117. N1-2-pyrimidinylsulfanilamide

118. Sulfadiazine (jan/usp/inn)

119. Ai3-01047

120. Sulfadiazine,(s)

121. Trisulfapyrimidine, Oral Suspension

122. Unii-0n7609k889

123. Sulfadiazine [usp:inn:ban:jan]

124. Prestwick_428

125. Spectrum_000986

126. Sulfadiazina Reig Jofre

127. Sulfacombin (salt/mix)

128. Prestwick0_000023

129. Prestwick1_000023

130. Prestwick2_000023

131. Prestwick3_000023

132. Spectrum2_001319

133. Spectrum3_001362

134. Spectrum4_000342

135. Spectrum5_000992

136. Sulfadiazine [mi]

137. [(4-aminophenyl)sulfonyl]pyrimidin-2-ylamine

138. Sulfadiazine [inn]

139. Sulfadiazine [jan]

140. Epitope Id:140083

141. N1-2-pyrimidylsulfanilamide

142. Sulfadiazine, >=99.0%

143. Dsstox_cid_24130

144. Dsstox_rid_80105

145. Sulfadiazine [vandf]

146. Dsstox_gsid_44130

147. Oprea1_081078

148. Schembl24176

149. Bspbio_000085

150. Bspbio_002884

151. Kbiogr_000743

152. Kbioss_001466

153. Sulfadiazine [mart.]

154. 5-25-10-00067 (beilstein Handbook Reference)

155. Mls000069423

156. Mls006011457

157. Divk1c_000543

158. Spectrum1500546

159. Sulfadiazine [usp-rs]

160. Sulfadiazine [who-dd]

161. Spbio_001417

162. Spbio_002006

163. Bpbio1_000095

164. Wln: T6n Cnj Bmswr Dz

165. Dtxsid7044130

166. Hms501l05

167. Kbio1_000543

168. Kbio2_001466

169. Kbio2_004034

170. Kbio2_006602

171. Kbio3_002104

172. Sulfadiazine [green Book]

173. Ninds_000543

174. Glxc-25873

175. Hms1568e07

176. Hms1921a13

177. Hms2090p09

178. Hms2092i15

179. Hms2095e07

180. Hms2235d19

181. Hms3371l19

182. Hms3655i10

183. Hms3712e07

184. Pharmakon1600-01500546

185. Sulfadiazine [orange Book]

186. Zinc120319

187. Sulfadiazine [ep Monograph]

188. Sulfadiazine [usp Impurity]

189. Albb-014888

190. Amy33423

191. Bcp12140

192. Hy-b0273

193. Sulfadiazine [usp Monograph]

194. Tox21_110360

195. Bbl013169

196. Bdbm50166571

197. Ccg-39257

198. Nsc757324

199. Recombinant Bactericidal/permeability-increasing Protein & Sulfadiazine

200. S1770

201. Stk317797

202. Sulfose Component Sulfadiazine

203. Terfonyl Component Sulfadiazine

204. 2-(p-aminobenzenesulfonamido)pyrimidin

205. Akos000119073

206. Lantrisul Component Sulfadiazine

207. Sulfaloid Component Sulfadiazine

208. Db00359

209. Ks-1144

210. Nsc-757324

211. Sulfadiazin 100 Microg/ml In Methanol

212. 2-(4-aminobenzenesulfonamido)pyrimidine

213. 4-amino-n-2-pyrimidylbenzenesulfonamide

214. Idi1_000543

215. Neotrizine Component Sulfadiazine

216. Sulfadiazine Component Of Sulfose

217. Ncgc00016305-02

218. Ncgc00016305-03

219. Ncgc00016305-04

220. Ncgc00016305-05

221. Ncgc00016305-06

222. Ncgc00016305-09

223. Ncgc00016305-10

224. Ncgc00016305-11

225. Ncgc00023291-03

226. Ncgc00023291-04

227. Sulfadiazine (trisulfapyrimidines)

228. Sulfadiazine Component Of Terfonyl

229. Trisulfapyrimidines (sulfadiazine)

230. 2-(4-aminobenzenesulfonylamino)pyrimidine

231. Ac-26817

232. Sulfadiazine 1000 Microg/ml In Methanol

233. Sulfadiazine Component Of Lantrisul

234. Sulfadiazine Component Of Sulfaloid

235. 4-amino-n-2-pyrimidinyl Benzenesulfonamide

236. Mixture Of Sulfadiazine, And Sulfamethazine

237. Sbi-0051520.p003

238. Sulfadiazine Component Of Neotrizine

239. Triple Sulfoid Component Sulfadiazine

240. 4-[[(pyrimidin-2-yl)amino]sulfonyl]aniline

241. Ab00052095

242. Benzenesulfonamide,4-amino-n-2-pyrimidinyl-

243. Ft-0674739

244. Ft-0674740

245. Ft-0674741

246. S0579

247. Sulfadiazine For Identification Of Impurity F

248. Sw196657-3

249. 4-amino-n-(2-pyrimidinyl) Benzenesulfonamide

250. Sulfadimidine Impurity B [ep Impurity]

251. 4-amino-n-(2-pyrimidinyl)benzenesulfonamide #

252. 68s359

253. C07658

254. D00587

255. D92267

256. Sulfadiazine Component Of Triple Sulfoid

257. Trisulfapyrimidine, Oral Suspension (salt/mix)

258. Ab00052095-13

259. Ab00052095-14

260. Ab00052095_15

261. Ab00052095_16

262. Benzenesulfonamide, 4-amino-n-(2-pyrimidinyl)-

263. Sulfadiazine, Vetranal(tm), Analytical Standard

264. Sulfonamides Duplex Component Sulfadiazine

265. A836115

266. Q-201759

267. Q2555060

268. Sr-01000002973-2

269. Sr-01000002973-3

270. Sulfadiazine Component Of Sulfonamides Duplex

271. Brd-k32273377-001-05-4

272. Brd-k32273377-001-09-6

273. F1657-1720

274. Sulfadiazine, Certified Reference Material, Tracecert(r)

275. Trisulfapyrimidines (sulfadiazine) [orange Book]

276. Z271004844

277. Sulfadiazine, European Pharmacopoeia (ep) Reference Standard

278. Sulfadiazine, United States Pharmacopeia (usp) Reference Standard

279. 4-amino-n-(2-pyrimidinyl)benzenesulfonamide, N1-(pyrimidin-2-yl)sulfanilamide

280. Sulfadiazine, Pharmaceutical Secondary Standard; Certified Reference Material

281. 141582-64-1

282. Sulfadiazine For Identification Of Impurity F, European Pharmacopoeia (ep) Reference Standard

2.3.3 Other Synonyms

1. Sulfadiazine Sodium

2. Sodium Sulfadiazine

3. Sodium Sulfapyrimidine

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 250.28 g/mol
Molecular Formula C10H10N4O2S
XLogP3-0.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count3
Exact Mass250.05244675 g/mol
Monoisotopic Mass250.05244675 g/mol
Topological Polar Surface Area106 Ų
Heavy Atom Count17
Formal Charge0
Complexity327
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 8  
Drug NameSilvadene
PubMed HealthSilver Sulfadiazine (On the skin)
Drug ClassesAntibacterial
Active IngredientSilver sulfadiazine
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyKing Pharms

2 of 8  
Drug NameSsd
PubMed HealthSulfadiazine (By mouth)
Drug ClassesAntibiotic
Active IngredientSilver sulfadiazine
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyDr Reddys La

3 of 8  
Drug NameSulfadiazine
PubMed HealthSilver Sulfadiazine (On the skin)
Drug ClassesAntibacterial
Drug LabelSulfadiazine is an oral sulfonamide anti-bacterial agent.Each tablet, for oral administration, contains 500 mg sulfadiazine. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, docusate sodium, microcrystallin...
Active IngredientSulfadiazine
Dosage FormTablet
RouteOral
Strength500mg
Market StatusPrescription
CompanySandoz

4 of 8  
Drug NameThermazene
Active IngredientSilver sulfadiazine
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyThepharmanetwork

5 of 8  
Drug NameSilvadene
PubMed HealthSilver Sulfadiazine (On the skin)
Drug ClassesAntibacterial
Active IngredientSilver sulfadiazine
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyKing Pharms

6 of 8  
Drug NameSsd
PubMed HealthSulfadiazine (By mouth)
Drug ClassesAntibiotic
Active IngredientSilver sulfadiazine
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyDr Reddys La

7 of 8  
Drug NameSulfadiazine
PubMed HealthSilver Sulfadiazine (On the skin)
Drug ClassesAntibacterial
Drug LabelSulfadiazine is an oral sulfonamide anti-bacterial agent.Each tablet, for oral administration, contains 500 mg sulfadiazine. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, docusate sodium, microcrystallin...
Active IngredientSulfadiazine
Dosage FormTablet
RouteOral
Strength500mg
Market StatusPrescription
CompanySandoz

8 of 8  
Drug NameThermazene
Active IngredientSilver sulfadiazine
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyThepharmanetwork

4.2 Drug Indication

For the treatment of rheumatic fever and meningococcal meningitis


5 Pharmacology and Biochemistry
5.1 Pharmacology

Sulfadiazine 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.)


Coccidiostats

Agents useful in the treatment or prevention of COCCIDIOSIS in man or animals. (See all compounds classified as Coccidiostats.)


Antiprotozoal Agents

Substances that are destructive to protozoans. (See all compounds classified as Antiprotozoal Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
SULFADIAZINE
5.3.2 FDA UNII
0N7609K889
5.3.3 Pharmacological Classes
Sulfonamides [CS]; Sulfonamide Antibacterial [EPC]
5.4 ATC Code

J01EC02

S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448


J01EC02

S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448


D - Dermatologicals

D06 - Antibiotics and chemotherapeutics for dermatological use

D06B - Chemotherapeutics for topical use

D06BA - Sulfonamides

D06BA01 - Silver sulfadiazine


J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01E - Sulfonamides and trimethoprim

J01EC - Intermediate-acting sulfonamides

J01EC02 - Sulfadiazine


5.5 Absorption, Distribution and Excretion

Route of Elimination

Sulfadiazine is excreted largely in the urine.


5.6 Metabolism/Metabolites

Sulfadiazine has known human metabolites that include Sulfadiazine hydroxylamine.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Mechanism of Action

Sulfadiazine is a competitive inhibitor of the bacterial enzyme dihydropteroate synthetase. This enzyme is needed for the proper processing of para-aminobenzoic acid (PABA) which is essential for folic acid synthesis. The inhibited reaction is necessary in these organisms for the synthesis of folic acid.


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Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750703400,"product":"SULPHADIZINE (API) (SULPHADIAZINE BP) SULPHADIZINE","address":"213, LAXMI PLAZA, LAXMI INDL.","city":"MUMBAI, MAHARASHTRA","supplier":"ADIA SHANGHAI PHARMA CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"ASHISH LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"510.00","actualQuantity":"510","unit":"KGS","unitRateFc":"18.6","totalValueFC":"9700.4","currency":"USD","unitRateINR":"1634.3","date":"24-Jun-2025","totalValueINR":"833512.83","totalValueInUsd":"9700.4","indian_port":"JNPT","hs_no":"29359013","bill_no":"2855225","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"SUITE 27G, WORLD PLAZA 855 SOUTH PUDONG ROAD, PUDONG, SHANGHAI CHINA","customerAddress":"213, LAXMI PLAZA, LAXMI INDL."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750703400,"product":"SULPHADIZINE (API) (SULPHADIAZINE BP) SULPHADIZINE","address":"213, LAXMI PLAZA, LAXMI INDL.","city":"MUMBAI, MAHARASHTRA","supplier":"ADIA SHANGHAI PHARMA CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"ASHISH LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"656.00","actualQuantity":"656","unit":"KGS","unitRateFc":"18.6","totalValueFC":"12477.4","currency":"USD","unitRateINR":"1634.3","date":"24-Jun-2025","totalValueINR":"1072126.31","totalValueInUsd":"12477.4","indian_port":"JNPT","hs_no":"29359013","bill_no":"2855225","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"SUITE 27G, WORLD PLAZA 855 SOUTH PUDONG ROAD, PUDONG, SHANGHAI CHINA","customerAddress":"213, LAXMI PLAZA, LAXMI INDL."}]
05-Jan-2022
28-Jun-2025
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ABOUT THIS PAGE

Looking for 68-35-9 / Sulfadiazine API manufacturers, exporters & distributors?

Sulfadiazine manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulfadiazine manufacturer or Sulfadiazine supplier.

PharmaCompass also assists you with knowing the Sulfadiazine API Price utilized in the formulation of products. Sulfadiazine API Price is not always fixed or binding as the Sulfadiazine Price is obtained through a variety of data sources. The Sulfadiazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Sulfadiazine

Synonyms

68-35-9, Sulphadiazine, Sulfapyrimidine, Sulfadiazin, Adiazine, Sulfazine

Cas Number

68-35-9

Unique Ingredient Identifier (UNII)

0N7609K889

About Sulfadiazine

One of the short-acting SULFONAMIDES used in combination with PYRIMETHAMINE to treat toxoplasmosis in patients with acquired immunodeficiency syndrome and in newborns with congenital infections.

N1-(Pyrimidin-2-yl)sulfanilamide Manufacturers

A N1-(Pyrimidin-2-yl)sulfanilamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N1-(Pyrimidin-2-yl)sulfanilamide, including repackagers and relabelers. The FDA regulates N1-(Pyrimidin-2-yl)sulfanilamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)sulfanilamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

N1-(Pyrimidin-2-yl)sulfanilamide Suppliers

A N1-(Pyrimidin-2-yl)sulfanilamide supplier is an individual or a company that provides N1-(Pyrimidin-2-yl)sulfanilamide active pharmaceutical ingredient (API) or N1-(Pyrimidin-2-yl)sulfanilamide finished formulations upon request. The N1-(Pyrimidin-2-yl)sulfanilamide suppliers may include N1-(Pyrimidin-2-yl)sulfanilamide API manufacturers, exporters, distributors and traders.

click here to find a list of N1-(Pyrimidin-2-yl)sulfanilamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

N1-(Pyrimidin-2-yl)sulfanilamide USDMF

A N1-(Pyrimidin-2-yl)sulfanilamide DMF (Drug Master File) is a document detailing the whole manufacturing process of N1-(Pyrimidin-2-yl)sulfanilamide active pharmaceutical ingredient (API) in detail. Different forms of N1-(Pyrimidin-2-yl)sulfanilamide DMFs exist exist since differing nations have different regulations, such as N1-(Pyrimidin-2-yl)sulfanilamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A N1-(Pyrimidin-2-yl)sulfanilamide DMF submitted to regulatory agencies in the US is known as a USDMF. N1-(Pyrimidin-2-yl)sulfanilamide USDMF includes data on N1-(Pyrimidin-2-yl)sulfanilamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N1-(Pyrimidin-2-yl)sulfanilamide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of N1-(Pyrimidin-2-yl)sulfanilamide suppliers with USDMF on PharmaCompass.

N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)sulfanilamide Drug Master File in Japan (N1-(Pyrimidin-2-yl)sulfanilamide JDMF) empowers N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)sulfanilamide JDMF during the approval evaluation for pharmaceutical products. At the time of N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)sulfanilamide suppliers with JDMF on PharmaCompass.

N1-(Pyrimidin-2-yl)sulfanilamide CEP

A N1-(Pyrimidin-2-yl)sulfanilamide CEP of the European Pharmacopoeia monograph is often referred to as a N1-(Pyrimidin-2-yl)sulfanilamide Certificate of Suitability (COS). The purpose of a N1-(Pyrimidin-2-yl)sulfanilamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of N1-(Pyrimidin-2-yl)sulfanilamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of N1-(Pyrimidin-2-yl)sulfanilamide to their clients by showing that a N1-(Pyrimidin-2-yl)sulfanilamide CEP has been issued for it. The manufacturer submits a N1-(Pyrimidin-2-yl)sulfanilamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a N1-(Pyrimidin-2-yl)sulfanilamide CEP holder for the record. Additionally, the data presented in the N1-(Pyrimidin-2-yl)sulfanilamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the N1-(Pyrimidin-2-yl)sulfanilamide DMF.

A N1-(Pyrimidin-2-yl)sulfanilamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)sulfanilamide suppliers with CEP (COS) on PharmaCompass.

N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)sulfanilamide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)sulfanilamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a N1-(Pyrimidin-2-yl)sulfanilamide NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of N1-(Pyrimidin-2-yl)sulfanilamide suppliers with NDC on PharmaCompass.

N1-(Pyrimidin-2-yl)sulfanilamide GMP

N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)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 N1-(Pyrimidin-2-yl)sulfanilamide GMP manufacturer or N1-(Pyrimidin-2-yl)sulfanilamide GMP API supplier for your needs.

N1-(Pyrimidin-2-yl)sulfanilamide CoA

A N1-(Pyrimidin-2-yl)sulfanilamide CoA (Certificate of Analysis) is a formal document that attests to N1-(Pyrimidin-2-yl)sulfanilamide's compliance with N1-(Pyrimidin-2-yl)sulfanilamide specifications and serves as a tool for batch-level quality control.

N1-(Pyrimidin-2-yl)sulfanilamide CoA mostly includes findings from lab analyses of a specific batch. For each N1-(Pyrimidin-2-yl)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.

N1-(Pyrimidin-2-yl)sulfanilamide may be tested according to a variety of international standards, such as European Pharmacopoeia (N1-(Pyrimidin-2-yl)sulfanilamide EP), N1-(Pyrimidin-2-yl)sulfanilamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (N1-(Pyrimidin-2-yl)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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