Find Urea API manufacturers, exporters & distributors on PharmaCompass

Urea API

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

8 API Suppliers, 7 USDMF, 1 CEP/COS, 1 JDMF, 1 Listed Suppliers

8 API Suppliers
7 USDMF
1 CEP/COS
1 JDMF
1 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

21 FDF Dossiers, 20 Europe, 1 South Africa

21 FDF Dossiers
20 Europe
1 South Africa

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 3 SPI Pharma, 2 Seqens, 9 DKSH, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 9 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 2 Clariant, 18 Corel Pharma Chem, 2 Finar, 6 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Lubrizol Life Science Health, 5 Microlex e.U, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 12 Roquette, 11 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 2 The Dow Chemical Company, 1 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

53 Topical, 49 Coating Systems & Additives, 31 Thickeners and Stabilizers, 30 Controlled & Modified Release, 29 Solubilizers, 19 Film Formers & Plasticizers, 18 Fillers, Diluents & Binders, 17 Parenteral, 12 Co-Processed Excipients, 12 Granulation, 11 Surfactant & Foaming Agents, 11 Direct Compression, 11 Emulsifying Agents, 9 Rheology Modifiers, 7 Taste Masking, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 4 Lubricants & Glidants, 3 Chewable & Orodispersible Aids, 2 Disintegrants & Superdisintegrants, 1 Soft Gelatin

GLOBAL SALES INFORMATION

20 Finished Drug Prices

globalSalesInformation
20 Finished Drug Prices

MARKET PLACE

4 APIs

marketPlace
4 APIs

REF. STANDARDS & IMPURITIES

1 EDQM , 3 USP

otherSolutions
1 EDQM
3 USP

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

189 RELATED EXCIPIENT COMPANIES

346EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown

Click the button for full data set

Also known as: Carbamide, 57-13-6, Carbonyldiamide, Isourea, Ureophil, Carbonyldiamine

Molecular Formula

CH₄N₂O

Molecular Weight

60.056 g/mol

InChI Key

XSQUKJJJFZCRTK-UHFFFAOYSA-N

FDA UNII

8W8T17847W

A compound formed in the liver from ammonia produced by the deamination of amino acids. It is the principal end product of protein catabolism and constitutes about one half of the total urinary solids.

1 2D Structure

Urea API

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

urea

2.1.2 InChI

InChI=1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)

2.1.3 InChI Key

XSQUKJJJFZCRTK-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C(=O)(N)N

2.2 Other Identifiers

2.2.1 UNII

8W8T17847W

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Basodexan

2. Carbamide

3. Carmol

2.3.2 Depositor-Supplied Synonyms

1. Carbamide

2. 57-13-6

3. Carbonyldiamide

4. Isourea

5. Ureophil

6. Carbonyldiamine

7. Ureaphil

8. Carbamimidic Acid

9. Pseudourea

10. Urevert

11. Alphadrate

12. Aquadrate

13. Calmurid

14. Carbaderm

15. Keratinamin

16. Carbonyl Diamide

17. Pastaron

18. Urepearl

19. Carbamide Resin

20. Ultra Mide

21. Varioform Ii

22. Aqua Care

23. Prespersion, 75 Urea

24. B-i-k

25. Basodexan

26. Carmol

27. Harnstoff

28. Mocovina

29. Nutraplus

30. Supercel 3000

31. Aqua Care Hp

32. Ureacin-20

33. Ureacin-10 Lotion

34. Ureacin-40 Creme

35. Onychomal

36. Panafil

37. Polyurea

38. Hyanit

39. Caswell No. 902

40. Carbonyl Diamine

41. Nci-c02119

42. Ccris 989

43. Aminoketone

44. Aquacare

45. Hsdb 163

46. Carbamimic Acid

47. Bubber Shet

48. Elaqua Xx

49. Keratinamin Kowa

50. Nsc 34375

51. Benural 70

52. Urea Ammonium Nitrate Solution

53. Epa Pesticide Chemical Code 085702

54. Ur

55. Ai3-01202

56. Carbamide;carbonyldiamide

57. Mfcd00008022

58. Nsc-34375

59. Azodicarboxylic Acid-diamide

60. Ins No.927a

61. E927b

62. (nh2)2co

63. Ins-927a

64. 37955-36-5

65. Helicosol

66. Chebi:16199

67. Urea Solution

68. E-927a

69. 8w8t17847w

70. 4744-36-9

71. Ncgc00090892-01

72. Dsstox_cid_1426

73. Dsstox_rid_76155

74. Mocovina [czech]

75. Dsstox_gsid_21426

76. Ure

77. Harnstoff [german]

78. Urea [jan]

79. Ureum

80. Antisepsis Bolus

81. Sterile Urea

82. Cas-57-13-6

83. Urea [usp:jan]

84. Urea, Acs

85. Einecs 200-315-5

86. Uree

87. Isoharnstoff

88. Cerovel

89. Karbamid

90. Urepeal

91. Uroderm

92. Amino Ketone

93. Amino-ketone

94. Urea Perhydrate

95. Pastaron Soft

96. Urea, Ultrapure

97. E-cardamoni

98. Aquacare Hp

99. Unii-8w8t17847w

100. Urepeal L

101. Carbamide Solution

102. Urea, Homopolymer

103. Beta-i-k

104. Pastaron 10

105. Pastaron 20

106. Pastaron (tn)

107. Pastaron 20 Soft

108. Carbonamidimidic Acid

109. Carmol 40

110. Cerovel (salt/mix)

111. Panafil (salt/mix)

112. Rubinol St 010

113. Urea, P.a.

114. Optigen 1200

115. Urea, 2m

116. Urea,(s)

117. Spectrum_000672

118. Urea [vandf]

119. Wln: Zvz

120. Carbamimidic Acid (van)

121. Spectrum2_001192

122. Spectrum3_001791

123. Spectrum4_001168

124. Spectrum5_001862

125. Urea (jp17/usp)

126. Urea, Analytical Standard

127. Urea, For Electrophoresis

128. Urea [hpus]

129. Urea [hsdb]

130. Urea [inci]

131. Urea (8ci,9ci)

132. Urea [fcc]

133. Urea [usp-rs]

134. Urea [who-dd]

135. Eucerin 10% Urea Lotion

136. Chembl985

137. Urea [ii]

138. Urea [mart.]

139. Urea [mi]

140. Ec 200-315-5

141. Urea [orange Book]

142. H2n-co-nh2

143. H2nc(o)nh2

144. Urea [ep Monograph]

145. Urea [usp Impurity]

146. Urea A.c.s. Reagent Grade

147. H2n-c(oh)=nh

148. Bspbio_003341

149. Kbiogr_001775

150. Kbioss_001152

151. U-cort Component Urea

152. Urea [usp Monograph]

153. Urea, Puriss., 99.5%

154. Mls001076688

155. Divk1c_000086

156. H2n-c(=nh)-oh

157. Ho-c(=nh)-nh2

158. Spectrum1500604

159. Urea, Ar, >=99%

160. Urea, Lr, >=99%

161. Spbio_001263

162. Alphaderm Component Urea

163. Gtpl4539

164. Carmol Hc Component Urea

165. Dtxsid4021426

166. Urea Component Of U-cort

167. Urea, >=99.0%

168. Urea, Molecular Biology Reagent

169. Bdbm24961

170. Chebi:48376

171. Hms500e08

172. Kbio1_000086

173. Kbio2_001152

174. Kbio2_003720

175. Kbio2_006288

176. Kbio3_002843

177. Calmurid Hc Component Urea

178. Urea 100 Microg/ml In Methanol

179. Ninds_000086

180. Hms1921i17

181. Hms2092c08

182. Hms2232p21

183. Pharmakon1600-01500604

184. Urea Component Of Alphaderm

185. Component Of Artra Ashy Skin Cream

186. Urea Component Of Carmol Hc

187. Amy37159

188. Bcp30439

189. Cs-b1800

190. Hy-y0271

191. Nsc34375

192. Str00449

193. Urea, Tested According To Ph.eur.

194. Zinc8214514

195. Tox21_111036

196. Tox21_202158

197. Tox21_300035

198. C0165

199. Ccg-40265

200. Nsc757375

201. S3687

202. Stl194286

203. Urea Component Of Calmurid Hc

204. Urea, Reagentplus(r), >=99.5%

205. Akos009031424

206. Urea, Nist(r) Srm(r) 2141

207. Urea, Saj First Grade, >=98.0%

208. Db03904

209. Nsc-757375

210. Urea, Jis Special Grade, >=99.0%

211. Urea, Meets Usp Testing Specifications

212. Urea, Vetec(tm) Reagent Grade, 99%

213. Idi1_000086

214. Urea Solution, 40 % (w/v) In H2o

215. Basodexan Pound>>carmol Pound>>carbamide

216. Ncgc00090892-02

217. Ncgc00090892-03

218. Ncgc00090892-04

219. Ncgc00090892-05

220. Ncgc00090892-06

221. Ncgc00254181-01

222. Ncgc00259707-01

223. Urea Solution, Bioultra, ~8 M In H2o

224. Smr000499585

225. Urea, Acs Reagent, 99.0-100.5%

226. 4,4-(3-oxapentanediyldioxy)dibenzaldehyde

227. Allantoin Impurity B [ep Impurity]

228. Sbi-0051552.p002

229. Urea, Bioreagent, Suitable For Cell Culture

230. B7781

231. Fluorouracil Impurity G [ep Impurity]

232. Ft-0645129

233. Ft-0675737

234. Ft-0675738

235. U0073

236. U0077

237. Urea, Reagentplus(r), >=99.5%, Pellets

238. Urea Solution, For Microbiology, 40% In H2o

239. C00086

240. Component Of Artra Ashy Skin Cream (salt/mix)

241. D00023

242. D70446

243. M02656

244. Q48318

245. Urea, P.a., Acs Reagent, 99.0-100.5%

246. Ab00052123_05

247. Sr-01000762961

248. Urea, Nist(r) Srm(r) 912a, Clinical Standard

249. Sr-01000762961-2

250. Urea, British Pharmacopoeia (bp) Reference Standard

251. Urea, European Pharmacopoeia (ep) Reference Standard

252. F0001-1490

253. Urea, Bioultra, For Molecular Biology, >=99.5% (t)

254. Urea, Bioxtra, Ph 7.5-9.5 (20 C, 5 M In H2o)

255. Urea, Nist Srm 2152, Combustion Calorimetric Standard

256. Z230747540

257. Urea, United States Pharmacopeia (usp) Reference Standard

258. 6e4eb293-4363-4d38-bf3b-1397372c31e5

259. Urea, 8 M (after Reconstitution With 16 Ml High Purity Water)

260. Urea, Puriss. P.a., Acs Reagent, Reag. Ph. Eur., >=99.5%

261. Urea, Pharmaceutical Secondary Standard; Certified Reference Material

262. Urea, Powder, Bioreagent, For Molecular Biology, Suitable For Cell Culture

263. Urea, Puriss., Meets Analytical Specification Of Ph. Eur., Bp, Usp, 99.0-100.5%, 99.0-101.0% (calc. On Dry Substance)

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	CH₄N₂O
Molecular Weight	60.056 g/mol
XLogP3	-1.4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	0
Exact Mass	60.032362755 g/mol
Monoisotopic Mass	60.032362755 g/mol
Topological Polar Surface Area	69.1 Å²
Heavy Atom Count	4
Formal Charge	0
Complexity	29
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

Dermatologic Agents; Diuretics, Osmotic

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

UREA IS /USED LESS COMMONLY THAN OTHER OSMOTIC AGENTS/ FOR THE SHORT-TERM REDUCTION OF INTRAOCULAR PRESSURE & VITREOUS VOL ... IN ANGLE-CLOSURE GLAUCOMA .. PRIOR TO SURGERY ... IN CHRONIC GLAUCOMA ... PRE- AND POSTOPERATIVE TREATMENT.

American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 1825

DOSE--USUAL, IV INFUSION, 100 MG TO 1 G/KG DAILY, AS 30% SOLN IN DEXTROSE INJECTION @ RATE NOT EXCEEDING 4 ML/MIN.

GENNARO. REMINGTON'S PHARM SCI 17TH ED 1985 p 935

USED TOPICALLY IN THE TREATMENT OF PSORIASIS, ICHTHYOSIS, ATOPIC DERMATITIS, AND OTHER DRY, SCALY CONDITIONS.

GENNARO. REMINGTON'S PHARM SCI 17TH ED 1985 p 785

For more Therapeutic Uses (Complete) data for UREA (14 total), please visit the HSDB record page.

4.2 Drug Warning

UREA SHOULD NOT BE USED IN PATIENTS WITH SEVERELY IMPAIRED RENAL FUNCTION.

American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 936

UREA IS OFTEN RECONSTITUTED WITH INVERT SUGAR SOLN. INVERT SUGAR CONTAINS FRUCTOSE, WHICH CAN CAUSE SEVERE REACTION (HYPOGLYCEMIA, NAUSEA, VOMITING, TREMORS, COMA, & CONVULSIONS) IN PATIENTS WITH HEREDITARY FRUCTOSE INTOLERANCE (ALDOLASE DEFICIENCY).

American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 936

In general osmotic diuretics are contraindicated in patients who are anuric due to severe renal disease or who are unresponsive to test doses of the drugs. Urea may cause thrombosis or pain if extravasation occurs, and it should not be admin to patients with impaired liver function because of the risk of elevation of blood ammonia levels. Both mannitol and urea are contraindicated in patients with active cranial bleeding.

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 696

4.3 Minimum/Potential Fatal Human Dose

In ruminants unaccustomed to urea, ingestion of 0.3-0.5 g urea/kg may be toxic ... The toxic dose of urea in (presumably unaccustomed) cattle is 0.45 g/kg (50 g total dose) but that animals can ingest more urea than this if the dose is increased gradually.

Booth, N.H., L.E. McDonald (eds.). Veterinary Pharmacology and Therapeutics. 5th ed. Ames, Iowa: Iowa State University Press, 1982., p. 1029

4.4 Drug Indication

10% hydrate skin
15% accelerate fibrin degradation
20-30% are antipruritic, break down keratin, decrease the thickness of the stratum corneum and are used in scaling conditions such as ichthysosis
40% are proteolytic and may be used to dissolve and peel dystrophic nails

[Patient Self Care, 2010]

5 Pharmacology and Biochemistry

5.1 Pharmacology

As a humectant, urea draws water into the striatum corneum.

5.2 ATC Code

B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05B - I.v. solutions

B05BC - Solutions producing osmotic diuresis

B05BC02 - Carbamide

D - Dermatologicals

D02 - Emollients and protectives

D02A - Emollients and protectives

D02AE - Carbamide products

D02AE01 - Carbamide

5.3 Absorption, Distribution and Excretion

SOME SMALL, WATER SOL, BUT NONIONIZABLE COMPD SUCH AS UREA READILY TRAVERSE MAMMALIAN MEMBRANES, PROBABLY ALONG WITH WATER, BY WAY OF THE PORES. THIS FILTRATION PROCESS IS PARTICULARLY RAPID BETWEEN CAPILLARIES & EXTRACELLULAR FLUID.

Hayes, W.J., Jr., E.R. Laws Jr., (eds.). Handbook of Pesticide Toxicology Volume 1. General Principles. New York, NY: Academic Press, Inc., 1991., p. 127

... UREA ... PENETRATES OTHER CELLS RAPIDLY, ENTERS THE BRAIN ONLY VERY SLOWLY ...

LaDu, B.N., H.G. Mandel, and E.L. Way. Fundamentals of Drug Metabolism and Disposition. Baltimore: Williams and Wilkins, 1971., p. 51

... DISTRIBUTED APPROX IN TOTAL BODY WATER ... HAVE BEEN USED FOR MEASUREMENT OF TOTAL BODY WATER.

LaDu, B.N., H.G. Mandel, and E.L. Way. Fundamentals of Drug Metabolism and Disposition. Baltimore: Williams and Wilkins, 1971., p. 53

EXCRETION OF UREA DURING SWEATING IN MAN: 1.84 SWEAT/PLASMA RATIO WITH PKA @ 13.8. /FROM TABLE/

LaDu, B.N., H.G. Mandel, and E.L. Way. Fundamentals of Drug Metabolism and Disposition. Baltimore: Williams and Wilkins, 1971., p. 143

For more Absorption, Distribution and Excretion (Complete) data for UREA (6 total), please visit the HSDB record page.

5.4 Mechanism of Action

... The primary mechanism of ammonia toxicosis appears to be inhibition of the citric acid cycle. There is an increase in anaerobic glycolysis, blood glucose, and blood lactate ... . Acidosis is manifested. The exact means by which ammonia blocks the citric acid cycle is not known. It is postulated that ammonia saturation of the glutamine-synthesizing system causes a backing-up in the citrate cycle, a decrease in its intermediates, and a decrease in energy production and cellular respiration, which leads to convulsions ... . The decrease of citrate cycle intermediates is postulated to result from reamination of pyruvic, ketoglutaric, and oxaloacetic acids.

Booth, N.H., L.E. McDonald (eds.). Veterinary Pharmacology and Therapeutics. 5th ed. Ames, Iowa: Iowa State University Press, 1982., p. 1031

API SUPPLIERS

01

Avanos

U.S.A

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

BIO Partnering at JPM

Not Confirmed

02

BioSpectra

U.S.A

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

BIO Partnering at JPM

Not Confirmed

03

Cambridge Isotope Laboratories

U.S.A

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

BIO Partnering at JPM

Not Confirmed

04

Merck Group

Germany

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

BIO Partnering at JPM

Not Confirmed

Not Confirmed

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

CEP/COS

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

JDMF

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Europe

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

South Africa

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Related Excipient Companies

Upload your portfolio for free, ask us

Excipients by Applications

Click here to find the perfect excipient manufacturers by their capabilities

Topical

Coating Systems & Additives

Thickeners and Stabilizers

Controlled & Modified Release

Solubilizers

Film Formers & Plasticizers

Fillers, Diluents & Binders

Parenteral

Co-Processed Excipients

Granulation

Surfactant & Foaming Agents

Direct Compression

Emulsifying Agents

Rheology Modifiers

Taste Masking

Empty Capsules

Vegetarian Capsules

API Stability Enhancers

Coloring Agents

Lubricants & Glidants

Chewable & Orodispersible Aids

Disintegrants & Superdisintegrants

Soft Gelatin

Global Sales Information

Do you need Business Intel? Ask us

Finished Drug Prices

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Market Place

Do you need sourcing support? Ask us

APIs

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

REF. STANDARDS & IMPURITIES

Upload your portfolio for free, ask us

EDQM

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USP

ABOUT THIS PAGE

Urea API Manufacturers

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

Urea API Suppliers

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

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

Urea API USDMF

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

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

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

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

Urea API CEP

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

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

Urea API GMP

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

Urea API CoA

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

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

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

Market Place

Home

Post Enquiry

Market Place

Find Urea API manufacturers, exporters & distributors on PharmaCompass

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

8 API Suppliers

7 USDMF

1 CEP/COS

1 JDMF

1 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

21 FDF Dossiers

20 Europe

1 South Africa

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

3 SPI Pharma

2 Seqens

9 DKSH

1 Pharm-RX Chemical

1 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

9 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

9 Actylis

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

30 BASF

2 Clariant

18 Corel Pharma Chem

2 Finar

6 Gangwal Chemicals

4 Ideal Cures Pvt Ltd

19 Kerry

3 Kima Chemical

6 Lonza Capsugel

9 Lubrizol Life Science Health

5 Microlex e.U

2 Nippon Fine Chemical

2 Nomisma Healthcare

2 Novo Excipients

1 Pharmatrans-Sanaq

2 Pluviaendo

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

12 Roquette

11 Seppic

2 Shandong Focus Biotechnology Co., Ltd

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

2 The Dow Chemical Company

1 Valens Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

53 Topical

49 Coating Systems & Additives

31 Thickeners and Stabilizers

30 Controlled & Modified Release

29 Solubilizers

19 Film Formers & Plasticizers

18 Fillers, Diluents & Binders

17 Parenteral

12 Co-Processed Excipients

12 Granulation

11 Surfactant & Foaming Agents

11 Direct Compression

11 Emulsifying Agents

9 Rheology Modifiers

7 Taste Masking

5 Empty Capsules

4 Vegetarian Capsules

4 API Stability Enhancers

4 Coloring Agents

4 Lubricants & Glidants

3 Chewable & Orodispersible Aids

2 Disintegrants & Superdisintegrants

1 Soft Gelatin

GLOBAL SALES INFORMATION