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Chemistry

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Also known as: Vitamin d2, Calciferol, 50-14-6, Viosterol, Ergorone, Ercalciol
Molecular Formula
C28H44O
Molecular Weight
396.6  g/mol
InChI Key
MECHNRXZTMCUDQ-RKHKHRCZSA-N
FDA UNII
VS041H42XC

Vitamin D
Derivatives of ERGOSTEROL formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. They differ from CHOLECALCIFEROL in having a double bond between C22 and C23 and a methyl group at C24.
Ergocalciferol is a Provitamin D2 Compound.
1 2D Structure

Vitamin D

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R,5R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
2.1.2 InChI
InChI=1S/C28H44O/c1-19(2)20(3)9-10-22(5)26-15-16-27-23(8-7-17-28(26,27)6)12-13-24-18-25(29)14-11-21(24)4/h9-10,12-13,19-20,22,25-27,29H,4,7-8,11,14-18H2,1-3,5-6H3/b10-9+,23-12+,24-13-/t20-,22+,25-,26+,27-,28+/m0/s1
2.1.3 InChI Key
MECHNRXZTMCUDQ-RKHKHRCZSA-N
2.1.4 Canonical SMILES
CC(C)C(C)C=CC(C)C1CCC2C1(CCCC2=CC=C3CC(CCC3=C)O)C
2.1.5 Isomeric SMILES
C[C@H](/C=C/[C@H](C)C(C)C)[C@H]1CC[C@@H]\2[C@@]1(CCC/C2=C\C=C/3\C[C@H](CCC3=C)O)C
2.2 Other Identifiers
2.2.1 UNII
VS041H42XC
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Calciferols

2. D2, Vitamin

3. Ergocalciferols

4. Vitamin D 2

5. Vitamin D2

2.3.2 Depositor-Supplied Synonyms

1. Vitamin D2

2. Calciferol

3. 50-14-6

4. Viosterol

5. Ergorone

6. Ercalciol

7. Deltalin

8. Drisdol

9. Ostelin

10. Oleovitamin D2

11. Sterogyl

12. Detalup

13. Condocaps

14. Crystallina

15. Fortodyl

16. Mulsiferol

17. Radsterin

18. Condol

19. Deratol

20. Diactol

21. Ertron

22. Geltabs

23. Daral

24. Novovitamin-d

25. Divit Urto

26. D-tracetten

27. Hi-deratol

28. Calciferon 2

29. Dee-ronal

30. Vitavel-d

31. D-arthin

32. Dee-ron

33. De-rat Concentrate

34. Vio-d

35. Rodine C

36. Activated Ergosterol

37. Calciferolum

38. Hyperkil

39. Rodinec

40. Ergocalciferolum

41. Mina D2

42. Vitamind2

43. Viosterol In Oil

44. Radiostol

45. Haliver

46. Davitin

47. Metadee

48. Mykostin

49. (+)-vitamin D2

50. Decaps

51. Infron

52. Shock-ferol

53. Davitamon D

54. Dee-osterol

55. Geltabs Vitamin D

56. Dee-roual

57. Buco-d

58. Oleovitamin D, Synthetic

59. Uvesterol D

60. Oleovitamin D

61. Chebi:28934

62. Irradiated Ergosta-5,7,22-trien-3-beta-ol

63. Synthetic Vitamin D

64. Vitamin D (ergocalciferol)

65. Condacaps

66. Viostdrol

67. Crtron

68. 9,10-secoergosta-5,7,10(19),22-tetraen-3-beta-ol

69. Vs041h42xc

70. Uvesterol-d

71. (3s,5z,7e,22e)-9,10-secoergosta-5,7,10,22-tetraen-3-ol

72. (5z,7e,22e)-(3s)-9,10-seco-5,7,10(19),22-ergostatetraen-3-ol

73. Ergosterol Activated

74. Mfcd00166988

75. Nsc-62792

76. (1s,3z)-3-[(2e)-2-[(1r,3as,7ar)-1-[(e,2r,5r)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol

77. Ergocalciferols

78. Dsstox_cid_233

79. (3beta,5z,7e,22e)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol

80. (5z,7e,22e)-(3s)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol

81. 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol, (3b,5z,7e,22e)-

82. 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol, (3.beta.,5z,7e,22e)-

83. Dsstox_rid_75449

84. Dsstox_gsid_20233

85. Vitamin D2 (ergocalciferol)

86. Ergocalciferolo

87. Disdrol

88. Radstein

89. Vd2-d3

90. Ergocalciferolo [dcit]

91. Smr000857106

92. Ergocalciferolum [inn-latin]

93. Vitamin D 2

94. Ergosterol Irradiated

95. Irradiated Ergosterol

96. Shock-ferol Sterogyl

97. Hsdb 819

98. Sorex C.r.

99. Einecs 200-014-9

100. Nsc 62792

101. Doral [vitamin Derivative]

102. Unii-vs041h42xc

103. Osteil

104. Delta-tracetten

105. Lanes

106. Delta-arthin

107. Beta-ol

108. D-forte

109. Ergocalciferol Oil

110. Eciferol D2

111. Vitamina D2

112. Calciferol (tn)

113. Cas-50-14-6

114. Ergoral D2

115. Ncgc00166307-01

116. Sterogyl-15

117. Sterogyl 15h

118. Cyclohexanol, 4-methylene-3-((2e)-2-((1r,3as,7ar)-octahydro-7a-methyl-1-((1r,2e,4r)-1,4,5-trimethyl-2-hexen-1-yl)-4h-inden-4-ylidene)ethylidene)-, (1s,3z)-

119. Cyclohexanol, 4-methylene-3-[(2e)-2-[(1r,3as,7ar)-octahydro-7a-methyl-1-[(1r,2e,4r)-1,4,5-trimethyl-2-hexen-1-yl]-4h-inden-4-ylidene]ethylidene]-, (1s,3z)-

120. Prestwick_554

121. Drisdol (tn)

122. Vio D

123. Ergocalciferol [usp:inn:ban:jan]

124. Vitamin D2 Solution

125. Ergo-d2

126. Osto-d2

127. Calciferol In Arach Oil

128. 9,10-seco(5z,7e,22e)-5,7,10(19),22-ergostatetraen-3-ol

129. Prestwick3_000420

130. Bmse000510

131. Vitamin D2 [mi]

132. (3-beta,5z,7e,22e)-9,10-secoergosta-5,7,10,(19),22-tetraen-3-ol

133. Vitamin D2 [fcc]

134. Schembl3420

135. Chembl1536

136. Ergocalciferol [inn]

137. Ergocalciferol [jan]

138. Ergocalciferol; 50-14-6

139. Bspbio_000380

140. Ergocalciferol (jp17/usp)

141. Ergocalciferol [hsdb]

142. Ergocalciferol [inci]

143. Mls001332467

144. Mls001332468

145. Ergocalciferol [vandf]

146. Vitamin D2 [who-ip]

147. Ergocalciferol [mart.]

148. Ergocalciferol, (+)-

149. Bpbio1_000418

150. Megxm0_000466

151. Ergocalciferol [usp-rs]

152. Ergocalciferol [who-dd]

153. Ergocalciferol [who-ip]

154. Dtxsid5020233

155. Acon1_002187

156. Hms2096c22

157. Hms2230e20

158. 1217448-46-8

159. Act02622

160. Cs-m1019

161. Zinc4629876

162. Ergocalciferol [ep Impurity]

163. Ergocalciferol [orange Book]

164. Tox21_112404

165. Tox21_202348

166. Tox21_302752

167. Bdbm50247883

168. Ergocalciferol [ep Monograph]

169. Lmst03010001

170. S4035

171. Ergocalciferol [usp Monograph]

172. Vitamin D2; Ergocalciferol; Deltalin

173. 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol, (3beta,5z,7e,22e)-

174. Akos022185284

175. Ccg-268614

176. Db00153

177. Ergocalciferolum [who-ip Latin]

178. Ergocalciferol, Sigma Reference Standard

179. Ncgc00166307-02

180. Ncgc00166307-03

181. Ncgc00256529-01

182. Ncgc00259897-01

183. As-11649

184. Bp-31119

185. Ergocalciferol (d2), Analytical Standard

186. Hy-76542

187. Irradiated Ergosta-5,7,22-trien-3beta-ol

188. Vitamin D2 Ergocalciferol 400,000 Iu/g

189. Ergocalciferol, 40,000,000 Usp Units/g

190. C05441

191. D00187

192. 166v988

193. Q139200

194. Q-201930

195. 9,10-secoergosta-5,7,10(19),22-tetraen-3b-ol

196. Ergocalciferol, >=98.0% (sum Of Enantiomers, Hplc)

197. 22-tetraen 3beta 9,10,secoergosta-5,7,10(19)-ol

198. 7e677dc1-e1c4-4fc5-8f4a-bce1857f7e87

199. Vitamin D2 Solution, 100 Mug/ml In Ethanol, 98% (cp)

200. (5e,7e,22e)-9,10-secoergosta-5,7,10,22-tetraen-3-ol

201. Ergocalciferol, British Pharmacopoeia (bp) Reference Standard

202. Ergocalciferol, European Pharmacopoeia (ep) Reference Standard

203. Ergocalciferol, United States Pharmacopeia (usp) Reference Standard

204. (3s,5z,7e,22e)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol

205. Vitamin D2. Short Expiry Date Due To Chemical Nature Of Component(s)

206. (3.beta.,5z,7e,22e)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol

207. 24-methyl-9,10-secocholesta-5,7,10( 19),22-tetraene-3.beta.-ol [who-ip]

208. Ergocalciferol (vitamin D2), Pharmaceutical Secondary Standard; Certified Reference Material

209. Ergocalciferol For System Suitability, Europepharmacopoeia (ep) Reference Standard

210. Vitamin D2 Solution, 1 Mg/ml In Ethanol, Ampule Of 1 Ml, Certified Reference Material

211. (1s,3z)-3-[(2e)-2-[(1r,3as,7ar)-7a-methyl-1-[(e,1r,4r)-1,4,5-trimethylhex-2-enyl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylene-cyclohexanol

212. 4-methylene-3-[2-[tetrahydro-7a-methyl-1-(1,4,5-trimethyl-2-hexenyl)-4(3ah)-indanylidene]ethylidene]-cyclohexanol

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 396.6 g/mol
Molecular Formula C28H44O
XLogP37.4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count1
Rotatable Bond Count5
Exact Mass396.339216023 g/mol
Monoisotopic Mass396.339216023 g/mol
Topological Polar Surface Area20.2 Ų
Heavy Atom Count29
Formal Charge0
Complexity678
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count3
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

MEDICATION (VET): ... Recommended for prophylaxis of milk fever in cows. ... Prevent atrophic rhinitis in pigs. ... Aid fracture healing in cats and dogs.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 653


MEDICATION (VET): To be effective ... supplementation with Ca & PO4. ... Fish meals & irradiated yeast may be used as supplemental ... source. ... Diets are routinely supplemented ... 1400-1600 IU/kg. Therapy for rickets ... Level 10-20 times daily requirement, alternate days for 1 wk. /Vitamin D/

Jones, L.M., et al. Veterinary Pharmacology & Therapeutics. 4th ed. Ames: Iowa State University Press, 1977., p. 773


In adults and children with nutritional rickets or osteomalacia and normal GI absorption, oral administration of ... ergocalciferol daily results in normal serum calcium and phosphate concentrations in about 10 days, radiographic evidence of healing of bone within 2-4 wk, and complete healing in about 6 months. ... Diet should be corrected and, after healing has occurred, supplemental doses of ergocalciferol may be discontinued in patients with normal GI absorption. In adults with severe malabsorption and vitamin D deficiency, /daily/ dosages ... have been given to correct osteomalacia. In children with malabsorption, oral ergocalciferol dosages ... have been recommended. In vitamin D-deficient infants with tetany and rickets, calcium should be administered orally or iv to control tetany. Vitamin D deficiency is then treated orally with /a daily dose/ of ergocalciferol ... until the bones have healed, ... .

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3519


In adults with Fanconi syndrome, oral ergocalciferol .. have been given along with treatment of acidosis. In children with Fanconi syndrome oral ergocalciferol ... have been used.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3519


For more Therapeutic Uses (Complete) data for VITAMIN D2 (11 total), please visit the HSDB record page.


4.2 Drug Warning

... Ergocalciferol should be administered with extreme caution, if at all, to patients with impaired renal function and with extreme caution in patient with heart disease, renal stones, or arterioscleroses.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3513


Initial signs and symptoms ... consists of weakness, fatigue, lassitude, headache, nausea, vomiting, and diarrhea. Obtundation and coma may develop. Early impairment of renal function from hypercalcemia is manifest by polyuria, polydipsia, nocturia, decreased urinary concentration ability, and proteinuria.

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. 1514


4.3 Drug Indication

Ergocalciferol is indicated for the treatment of hypoparathyroidism, refractory rickets, and familial hypophosphatemia. Hypoparathyroidism is the result of inadequate parathyroid hormone production that occurs due to the presence of damage or removal of the parathyroid glands. This condition produces decreased calcium and increased phosphorus levels. Rickets is a condition produced due to a deficiency in vitamin D, calcium or phosphorus. However, this condition can also be related to renal diseases. It is characterized to present weak or soft bones. Familial hypophosphatemia is characterized by the impaired transport of phosphate and an altered vitamin D metabolism in the kidneys. The presence of this condition can derive in the presence of osteomalacia, bone softening and rickets.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

After the activation of the vitamin D receptor, some of the biological changes produced by ergocalciferol include mobilization and accretion of calcium and phosphorus in the bone, absorption of calcium and phosphorus in the intestine, and reabsorption of calcium and phosphorus in the kidney. Some other effects known to be produced due to the presence of vitamin D are osteoblast formation, fetus development, induction of pancreatic function, induction of neural function, improvement of immune function, cellular growth and cellular differentiation. When compared to its vitamin D counterpart [cholecalciferol], ergocalciferol has been shown to present a reduced induction of calcidiol and hence, it is less potent. Ergocalciferol supplementation in patients with end-stage renal disease has been shown to generate a significant benefit in lab parameters of bone and mineral metabolism as well as improvement in glycemic control, serum albumin levels and reduced levels of inflammatory markers.


5.2 MeSH Pharmacological Classification

Bone Density Conservation Agents

Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)


Calcium-Regulating Hormones and Agents

Hormones and molecules with calcium-regulating hormone-like actions that modulate OSTEOLYSIS and other extra-skeletal activities to maintain calcium homeostasis. (See all compounds classified as Calcium-Regulating Hormones and Agents.)


Vitamins

Organic substances that are required in small amounts for maintenance and growth, but which cannot be manufactured by the human body. (See all compounds classified as Vitamins.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ERGOCALCIFEROL
5.3.2 FDA UNII
VS041H42XC
5.3.3 Pharmacological Classes
Provitamin D2 Compound [EPC]; Ergocalciferols [CS]
5.4 ATC Code

A - Alimentary tract and metabolism

A11 - Vitamins

A11C - Vitamin a and d, incl. combinations of the two

A11CC - Vitamin d and analogues

A11CC01 - Ergocalciferol


5.5 Absorption, Distribution and Excretion

Absorption

Ergocalciferol is absorbed in the intestine and carried to the liver in chylomicrons. Its intestinal absorption does not present limitations unless the presence of conditions related to fat malabsorption. However, for absorption to take place, the presence of bile is required.


Route of Elimination

The active form of ergocalciferol, calcitrol, cannot be maintained for long periods in storage tissue mainly in periods of dietary or UVB deprivation. Therefore, ergocalciferol and its metabolites are excreted via the bile with a minor contribution of renal elimination. This major fecal elimination is explained due to the cubilin-megalin receptor system-mediated renal reuptake of vitamin D metabolites bound to vitamin D binding protein.


Volume of Distribution

The amount of circulating ergocalciferol is very limited as this compound is rapidly stored in fat tissue such as adipose tissue, liver and muscle. This is very obvious in reports that indicate that circulating ergocalciferol is significantly reduced in obese patients.


Clearance

There are no formal reports regarding the clearance rate of ergocalciferol. Due to the structural similarity, it is recommended to consult this parameter with [cholecalciferol]. On the other hand, the proposed renal clearance of calcitriol is of 31 ml/min.


Both vitamin D2 & vitamin D3 are absorbed from the small intestine, although vitamin D3 may be absorbed more efficiently. The exact portion of the gut that is most effective in vitamin D absorption reflects the vehicle in which the vitamin is dissolved. Most of the vitamin appears first within chylomicrons in lymph.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1729


The presence of bile is required for absorption of ergocalciferol and the extent of GI absorption may be decreased in patients with hepatic, biliary, or GI disease (e.g., Crohn's disease, Whipple's disease, sprue).

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3515


A longitudinal, randomized, double blind, placebo controlled study was conducted for 6 months to monitor ultraviolet B light exposure in human milk-fed infants both with and without supplemental vitamin D2, and to measure longitudinally the bone mineral content, growth, and serum concentrations of calcium, phosphorus, 25-hydroxyvitamin D3, 25-hydroxyvitamin D2, 1,25-dihydroxyvitamin D, and parathyroid hormone. Sequential sampling was performed of 46 human milk-fed white infants; 24 received 400 IU/day of vitamin D2, and 22 received placebo. An additional 12 patients were followed who received standard infant formula. 83% of patients completed a full 6 months of the study. Ultraviolet B light exposure and measurements of growth did not differ between groups. At 6 months, the human milk groups did not differ significantly in bone mineral content or serum concentrations of parathyroid hormone or 1,25-dihydroxyvitamin D, although total 25-hydroxyvitamin D values were significantly less in the unsupplemented human milk group (23.53 + or - 9.94 vs 36.96 + or - 11.86 ng/ml; p< 0.01). However, 25-hydroxyvitamin D3 serum concentrations were significantly higher in the unsupplemented human milk-fed group compared with the supplemented group (21.77 + or - 9.73 vs 11.74 + or - 10.27 ng/ml, p< 0.01) by 6 months of age. It was concluded that unsupplemented, human milk-fed infants had no evidence of vitamin D deficiency during the first 6 months of life.

PMID:2783734 Greer FR, Marshall S; J Pediatr 114 (2): 204-12 (1989)


A comparison was made of the ability of ergocalciferol and cholecalciferol to elevate plasma concentrations of vitamin D and 25-hydroxyvitamin D in cats. Cholecalciferol, given as an oral bolus in oil, resulted in a rapid elevation of plasma concentration of cholecalciferol followed by a rapid decline. In contrast, 25-hydroxyvitamin D concentration in plasma increased until day 3 after administration and remained elevated for a further 5 days. When 337 microg of both cholecalciferol and ergocalciferol in oil were given as an oral bolus to 10 cats, the peak plasma concentrations of cholecalciferol and ergocalciferol occurred at 8 or 12 h after administration. Peak concentrations of cholecalciferol were over twice those of ergocalciferol (570 +/- 80 vs. 264 +/- 42 nmol/l). The area under the curve 0-169 h for cholecalciferol was also more than twice that for ergocalciferol. When ergocalciferol and cholecalciferol were administered in a parenteral oil-based emulsion, higher concentrations of 25-hydroxyvitamin D3 than 25-hydroxyvitamin D2 were maintained in plasma. When both vitamins were included in the diet in the nutritional range, plasma concentrations of 25-hydroxyvitamin D2 were 0.68 of those of 25-hydroxyvitamin D3. Discrimination against ergocalciferol by cats appears to result from differences in affinity of the binding protein for the metabolites of the two forms of vitamin D. These results indicate that cats discriminate against ergocalciferol, and use it with an efficiency of 0.7 of that of cholecalciferol to maintain plasma 25-hydroxyvitamin D concentration.

PMID:15379909 Morris JG; J Anim Physiol Anim Nutr (Berl) 86 (7-8): 229-38 (2002)


Osteoporosis diminishes the quality of life in adults with cystic fibrosis (CF). Vitamin D deficiency resulting from malabsorption may be a factor in the etiology of low bone mineral density (BMD) in patients with CF. OBJECTIVE: Absorption of oral ergocalciferol (vitamin D2) and the consequent response of 25-hydroxyvitamin D in 10 adults with CF and exocrine pancreatic insufficiency was compared with that of 10 healthy control subjects. DESIGN: In this pharmacokinetic study, CF patients and control subjects were pair-matched on age, sex, and race. Each subject consumed 2500 microg oral vitamin D2 with a meal. The CF group also took pancreatic enzymes that provided > or = 80000 U lipase. Blood samples were obtained at baseline and at 5, 10, 24, 30, and 36 h after vitamin D2 consumption to measure serum vitamin D2 and 25-hydroxyvitamin D concentrations. RESULTS: Vitamin D2 concentrations in all subjects were near zero at baseline. CF patients absorbed less than one-half the amount of oral vitamin D2 that was absorbed by control subjects (P < 0.001). Absorption by the CF patients varied greatly; 2 patients absorbed virtually no vitamin D2. The rise in 25-hydroxyvitamin D in response to vitamin D2 absorption was significantly lower over time in the CF group than in the control group (P = 0.0012). CONCLUSIONS: Vitamin D2 absorption was significantly lower in CF patients than in control subjects. These results may help explain the etiology of vitamin D deficiency in CF patients, which may contribute to their low BMD.

PMID:11237938 Lark RK et al; Am J Clin Nutr 73 (3): 602-6 (2001)


5.6 Metabolism/Metabolites

Ergocalciferol is inactive and hence, the first step in the body is ruled by the conversion of this parent compound to 25-hydroxyvitamin D by the action of CYP2R1 followed by the generation of the major circulating metabolite, 1,25-dihydroxyvitamin D or calcitrol. The generation of this major metabolite is ruled by the activity of CYP27B1 which is a key 1-hydroxylase and CYP24A1 which is responsible for the 25-hydroxylation. As part of the minor metabolism, ergocalciferol is transformed into 25-hydroxyvitamin D in the liver by the activity of D-25-hydroxylase and CYP2R1. As well, the formation of 24(R),25dihydroxyvitamin D is performed mainly in the kidneys by the action of 25-(OH)D-1-hydroxylase and 25-(OH)D-24-hydroxylase. Additionally, there are reports indicating significant activity of 3-epimerase in the metabolism of ergocalciferol which modifies the hydroxy group in C3 from the alpha position to a beta. The epimers formed seemed to have a reduced affinity for the vitamin D plasma proteins and to the vitamin D receptor. An alternative activation metabolic pathway has been reported and this process is characterized by the activity of CYP11A1 and its hydroxylation in the C-20. This 20-hydroxylated vitamin D seems to have similar biological activity than calcitriol.


Vitamin D ... is hydroxylated at the 25 position in liver to produce 25-hydroxy-vitamin D3 which is the major metabolite circulating in the plasma. The metabolite is further hydroxylated in the kidney to 1,25-dihydroxy-vitamin D3, the most active metabolite in initiating intestinal transport of calcium & phosphate & mobilization of mineral from bone.

American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 1952


A polar, biologically active metabolite of vitamin D2, 25-hydroxyergocalciferol, which is about 1.5 times more active in curing rickets in rats, has been isolated from pig plasma.

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. 1786


Dihydrotachysterol is a vitamin D analog that may be regaurded as a reduction product of vitamin D2 ... Dihydrotachysterol is about 1/450 as active as vitamin D in the antirachitic assay, but at high doses it is much more effective than vitamin D in mobilizing bone mineral.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1730


Vitamin D2 has known human metabolites that include Vitamin D2 3-glucuronide.

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


5.7 Biological Half-Life

Ergocalciferol can be found circulation for 1-2 days. This quick turnover is presented due to hepatic conversion and uptake by fat and muscle cells where it is transformed to the active form.


19 to 48 hours (however, stored in fat deposits in body for prolonged periods).

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. 2850


5.8 Mechanism of Action

For its activity, ergocalciferol is required to be transformed to its major active circulating hydroxylated metabolite and transported to the target organs in order to bind to its target, the vitamin D receptor. The activation of the vitamin D receptor is part of the vitamin D endocrine system and it is described by the production of a change in the transcription rates of the vitamin D receptor target genes. The target genes in the DNA affected by the presence of ergocalciferol are called vitamin D response elements which are dependent on co-modulators. The vitamin D receptor is a transcription factor and member of the steroid hormone nuclear receptor family. It presents a DNA binding domain (VDRE) that, when activated, recruits coregulatory complexes to regulate the genomic activity. Additionally, ergocalciferol presents nongenomic effects such as the stimulation of intestinal calcium transport via transcaltachia.


The mechanism of action of calcitriol, the activated form of vitamin D, resembles that of the steroid and thyroid hormones. Thus, calcitriol binds to cytosolic receptors within target cells, and the receptor-hormone complex interacts with the DNA of certain genes to either enhance or inhibit their transcription. Structural analysis of the calcitriol receptor indicates that it belongs to the same supergene family as the steroid receptors. Calcitriol also appears to exert a few effects that occur too rapidly to be explained by genomic actions. /Calcitriol/

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1728


The mechanisms responsible for mobilization of bone salts have been only partially defined, and the interaction of multiple factors appears to be involved. Paradoxically, the cells responsible for bone resorption (osteoclasts) are not directly acted upon by calcitriol and do not appear to contain calcitriol receptors. Instead, calcitriol causes an increase in the number of osteoclasts available to resorb bone; this may result from an action upon myeloid hematopoietic precursor cells that are induced to differentiate toward functional osteoclasts. The cells responsible for bone formation (osteoblasts) do contain receptors, and calcitriol causes them to elaborate several proteins, including osteocalcin, a vitamin K-dependent protein that contains gamma-carboxyglutamic acid residues. The exact role of this protein is not known, but other unidentified substances are also elaborated that appear to stimulate the function of osteoclasts. In addition, calcitriol acts synergistically with gamma-interferon to increase the production of interleukin-1, a lymphokine that promotes bone resorption.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1728


API SUPPLIERS

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Transo-Pharm USA LLC

U.S.A

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Formosa Laboratories

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China

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ALP Pharm

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USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2014-07-21

Pay. Date : 2014-07-11

DMF Number : 24189

Submission : 2010-09-20

Status : Active

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Rp Scherer Corp

Germany

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Rp Scherer Corp

Germany
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Submission : 1971-09-15

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Safc Inc

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Safc Inc

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DMF Review : Complete

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Univ Wisconsin

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Vitamin D

About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.
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Ergocalciferol

About the Company : Chengdu Yazhong Bio-pharmaceutical Co., Ltd., founded in 2002, is a leading company with plant extracts, APIs and medical intermediates. Our company is equipped with GMP approved m...

Chengdu Yazhong Bio-pharmaceutical Co., Ltd., founded in 2002, is a leading company with plant extracts, APIs and medical intermediates. Our company is equipped with GMP approved manufacturing feasibilities and state-of-art test equipments, with big technical supports and cooperation by state scientific research institutions and universities.Core products: Diosmin, Diosmin/Hesperidin(90/10), Resveratrol, Ergosterol, Artemisinin.Documents for products:GMP availableMSDS availableStability Data availableDMF available
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Vitamin D

About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture fo...

Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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Vitamin D

About the Company : Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediate...

Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediates, and fine chemicals for worldwide markets. With decades of development, now we grow to a leading and outstanding company. We are not just a trading company, but a comprehensive solutions supplier. With our sound knowledge of pharmaceutical business, our advantage is to integrate resources and adapt to all different demands of markets. We are a young but dynamic and energetic company with high efficient and high flexible decision making system.
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Royal DSM

Netherlands
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Royal DSM

Netherlands
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Vitamin D2

About the Company : Royal DSM, founded in 1902, is a global, purpose-led health, nutrition, and bioscience company that specializes in human and animal health and nutrition solutions. Its primary goal...

Royal DSM, founded in 1902, is a global, purpose-led health, nutrition, and bioscience company that specializes in human and animal health and nutrition solutions. Its primary goal is to develop health and nutrition solutions that are scientifically sound. Royal DSM's products and solutions address some of the world's most pressing issues while also adding economic, environmental and societal value to all stakeholders. More than 2.5 billion people worldwide use the company's solutions. Royal DSM and its affiliated companies employ approximately 23,000 people worldwide and generate around €10 billion in net sales per year.
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Vitamin D

About the Company : 30+ year old company possessing and continuously innovating its expertise in Stabilized Vitamins, Herbal Extracts & Formulations, Food Supplements, Tasteless Minerals and API's. Ou...

30+ year old company possessing and continuously innovating its expertise in Stabilized Vitamins, Herbal Extracts & Formulations, Food Supplements, Tasteless Minerals and API's. Our Pharma division specialises in manufacturing Active Pharmaceutical Ingredients (APIs) and stabilised vitamins. Over the past 33+ years, through our advanced R&D facility, we have been continuously enhancing the ingredients used in the manufacture of formulations.
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Ergocalciferol

About the Company : Vital Thearpeutics & Formulations Private Limited is a dedicated effort to be a reliable partner by offering products and services with highest quality standards in the domains of ...

Vital Thearpeutics & Formulations Private Limited is a dedicated effort to be a reliable partner by offering products and services with highest quality standards in the domains of Contract Manufacturing, Vitamins & Food Ingredients and Animal Health. We at Vital understand and appricate the importance of meeting the customer requirements and aim towards customer delight. Our Contract manufacturing services cater to some of best Multi-national Companies and other domestic pharma majors. Vital Therapeutics & Formulations is know for adhering to world class quality standards and service standards. Vital is a Unique Contract Manufacturing company designed to meet International Regulatory requirements such as cGMP, WHO, ISO 9001 & FSSC 22000.
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Vitamin D

About the Company : Founded in 2003, Zhejiang Tianyu Pharmaceutical Co., Ltd. is a joint-stock pharmaceutical company specializing in the research, development and manufacture of APIs and advanced pha...

Founded in 2003, Zhejiang Tianyu Pharmaceutical Co., Ltd. is a joint-stock pharmaceutical company specializing in the research, development and manufacture of APIs and advanced pharmaceutical intermediates. The company has a registered capital of 120 million yuan and covers an area of ​​700 mu. The factory has more than 2,600 employees.
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API Reference Price

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ROAD, MAJIWADA,","city":"THANE, MAHARASHTRA","supplier":"FERMENTA BIOTECH LIMITED","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"DONGKOOK PHARMACEUTICAL","customerCountry":"KOREA, REPUBLIC OF","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"4000","totalValueFC":"3937.8","currency":"USD","unitRateINR":288000,"date":"16-Jan-2021","totalValueINR":"288000","totalValueInUsd":"3937.8","indian_port":"DELHI AIR","hs_no":"29362940","bill_no":"7952519","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"DIL COMPLEX, S. V. 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V. ROAD,","city":"THANE, MAHARASHTRA","supplier":"FERMENTA BIOTECH LIMITED","supplierCountry":"INDIA","foreign_port":"ATHINAI","customer":"G.A. PHARMACEUTICALS S.A.","customerCountry":"GREECE","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2487","totalValueFC":"2451.7","currency":"USD","unitRateINR":179313,"date":"28-Jan-2021","totalValueINR":"179313","totalValueInUsd":"2451.7","indian_port":"Dahez-SEZ","hs_no":"29362940","bill_no":"4001134","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"DIL COMPLEX, S. V. ROAD,, THANE, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q1","strtotime":1611945000,"product":"CHOLECALCIFEROL (PH.","address":"DIL COMPLEX, S. V. 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03-Jan-2021
30-Nov-2024
KGS
overview
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Average Price (USD/KGS)

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)
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Drugs in Development

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PluriPain-PMS, an advanced, all natural anti-inflammatory and mood-enhancing Women’s Health formula to combat specific symptoms associated with the menstrual cycle.


Lead Product(s): Vitamin D,Calcium,Potassium

Therapeutic Area: Immunology Brand Name: PluriPain-PMS

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 05, 2023

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01

BioAdaptives

U.S.A
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

BioAdaptives

U.S.A
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : PluriPain-PMS, an advanced, all natural anti-inflammatory and mood-enhancing Women’s Health formula to combat specific symptoms associated with the menstrual cycle.

Brand Name : PluriPain-PMS

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 05, 2023

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Details:

SFA-002 oral pill acts as down-regulating levels of pro-inflammatory cytokines involved in the pathogenesis of psoriasis including TNF-α, IL-23, IL-12, IL-17 and INF-γ, and down-regulating autoimmunity.


Lead Product(s): SFA-002,Vitamin D,Magnesium

Therapeutic Area: Dermatology Brand Name: SFA-002

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 14, 2023

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02

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : SFA-002 oral pill acts as down-regulating levels of pro-inflammatory cytokines involved in the pathogenesis of psoriasis including TNF-α, IL-23, IL-12, IL-17 and INF-γ, and down-regulating autoimmunity.

Brand Name : SFA-002

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 14, 2023

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Details:

SFA002 is a new oral therapeutic agent for the treatment of mild-moderate psoriasis. SFA-002 is a potential multi-target and disease-modifying therapeutic that has demonstrated efficacy, safety and durability in Phase 1a studies.


Lead Product(s): SFA-002,Vitamin D,Magnesium

Therapeutic Area: Dermatology Brand Name: SFA-002

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 11, 2023

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : SFA002 is a new oral therapeutic agent for the treatment of mild-moderate psoriasis. SFA-002 is a potential multi-target and disease-modifying therapeutic that has demonstrated efficacy, safety and durability in Phase 1a studies.

Brand Name : SFA-002

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 11, 2023

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Details:

Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have previously been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in Company's European Phase IIb trial.


Lead Product(s): GAD65-Alum,Vitamin D

Therapeutic Area: Endocrinology Brand Name: Diamyd

Study Phase: Phase IIIProduct Type: Vaccine

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 27, 2022

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : GAD65-Alum,Vitamin D

Therapeutic Area : Endocrinology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have previously been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in Company's Europ...

Brand Name : Diamyd

Molecule Type : Vaccine

Upfront Cash : Not Applicable

November 27, 2022

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Details:

The diabetes vaccine Diamyd® (GAD-alum) is an antigen-specific immunotherapy for the preservation of endogenous insulin production. The primary endpoints of safety and tolerability were met in the open-label investigator-initiated Phase II clinical trial GADinLADA.


Lead Product(s): GAD65-Alum,Vitamin D

Therapeutic Area: Endocrinology Brand Name: Diamyd

Study Phase: Phase IIIProduct Type: Vaccine

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 20, 2022

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : GAD65-Alum,Vitamin D

Therapeutic Area : Endocrinology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : The diabetes vaccine Diamyd® (GAD-alum) is an antigen-specific immunotherapy for the preservation of endogenous insulin production. The primary endpoints of safety and tolerability were met in the open-label investigator-initiated Phase II clinical tria...

Brand Name : Diamyd

Molecule Type : Vaccine

Upfront Cash : Not Applicable

September 20, 2022

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Details:

Primary endpoints of safety and tolerability were met in Phase II clinical trial GADinLADA, in which diabetes vaccine Diamyd (GAD-alum) was administered directly into lymph node of 14 patients aged 30 to 70 years with autoimmune form of diabetes called LADA.


Lead Product(s): GAD-alum,Vitamin D

Therapeutic Area: Endocrinology Brand Name: Diamyd

Study Phase: Phase IIProduct Type: Vaccine

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 07, 2022

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06

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Primary endpoints of safety and tolerability were met in Phase II clinical trial GADinLADA, in which diabetes vaccine Diamyd (GAD-alum) was administered directly into lymph node of 14 patients aged 30 to 70 years with autoimmune form of diabetes called L...

Brand Name : Diamyd

Molecule Type : Vaccine

Upfront Cash : Not Applicable

July 07, 2022

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Details:

The diabetes vaccine Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. The Phase III trial DIAGNODE-3, with a planned start date later during 2021 and primary completion end of 2025.


Lead Product(s): rhGAD65,Vitamin D

Therapeutic Area: Endocrinology Brand Name: Diamyd

Study Phase: Phase IIIProduct Type: Vaccine

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 17, 2021

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : The diabetes vaccine Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. The Phase III trial DIAGNODE-3, with a planned start date later during 2021 and primary completion end of 2025.

Brand Name : Diamyd

Molecule Type : Vaccine

Upfront Cash : Not Applicable

September 17, 2021

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Details:

The results support a precision medicine approach with Diamyd® where significant effect on the preservation of endogenous insulin producing capacity and improved blood glucose control was seen in individuals that carry a specific genotyp, HLA DR3-DQ2.


Lead Product(s): GAD-alum,Vitamin D

Therapeutic Area: Endocrinology Brand Name: Diamyd

Study Phase: Phase IIProduct Type: Vaccine

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2021

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : The results support a precision medicine approach with Diamyd® where significant effect on the preservation of endogenous insulin producing capacity and improved blood glucose control was seen in individuals that carry a specific genotyp, HLA DR3-DQ2.

Brand Name : Diamyd

Molecule Type : Vaccine

Upfront Cash : Not Applicable

June 02, 2021

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Details:

The patients, diagnosed with type 1 diabetes, have been given the diabetes vaccine Diamyd® directly into the lymph node on three occasions, one month apart, in combination with oral vitamin D (or its placebo) during four months, starting 30 days prior to the first injection.


Lead Product(s): GAD65-alum,Vitamin D

Therapeutic Area: Endocrinology Brand Name: Diamyd

Study Phase: Phase IIProduct Type: Vaccine

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 21, 2021

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : GAD65-alum,Vitamin D

Therapeutic Area : Endocrinology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : The patients, diagnosed with type 1 diabetes, have been given the diabetes vaccine Diamyd® directly into the lymph node on three occasions, one month apart, in combination with oral vitamin D (or its placebo) during four months, starting 30 days prior t...

Brand Name : Diamyd

Molecule Type : Vaccine

Upfront Cash : Not Applicable

May 21, 2021

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Details:

All 50 patients who participated in the extension of Diamyd Medical's Phase IIb trial DIAGNODE-2 with the diabetes vaccine Diamyd® have now made their 24-month visit, and data will be presented in early July.


Lead Product(s): Recombinant human glutamic acid decarboxylase,Vitamin D

Therapeutic Area: Endocrinology Brand Name: Diamyd

Study Phase: Phase IIProduct Type: Vaccine

Sponsor: Icon Plc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 29, 2021

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : Recombinant human glutamic acid decarboxylase,Vitamin D

Therapeutic Area : Endocrinology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Icon Plc

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : All 50 patients who participated in the extension of Diamyd Medical's Phase IIb trial DIAGNODE-2 with the diabetes vaccine Diamyd® have now made their 24-month visit, and data will be presented in early July.

Brand Name : Diamyd

Molecule Type : Vaccine

Upfront Cash : Not Applicable

April 29, 2021

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INTERMEDIATES SUPPLIERS

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01

Pharma, Lab & Chemical Expo
Not Confirmed
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Pharma, Lab & Chemical Expo
Not Confirmed
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CAS Number : 99-34-3

End Use API : Vitamin D

About The Company : Indian Drugs & Chemicals has a wealth of knowledge & expertise that’s incomparable. We utilize this experience to provide both companies & individuals with im...

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02

LinkChem

China
Pharma, Lab & Chemical Expo
Not Confirmed
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LinkChem

China
Pharma, Lab & Chemical Expo
Not Confirmed
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CAS Number : 64190-52-9

End Use API : Vitamin D

About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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FDF Dossiers

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01

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Pharma, Lab & Chemical Expo
Not Confirmed

Calciferol

Brand Name : A-Lennon Calciferol

Dosage Form : TAB

Dosage Strength : 50000iu/ml

Packaging : 100X1iu/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

02

arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Ergocalciferol

Brand Name : Calciferol Oily Solution

Dosage Form : DRP

Dosage Strength : 50000iu/ml

Packaging : 15X1iu/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

03

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Vitamin D

Brand Name :

Dosage Form : Soft Gel Capsule

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

04

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
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Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin D2

Brand Name : ITN66A

Dosage Form : TPN

Dosage Strength : 1ZZZ

Packaging : 510X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin D2

Brand Name : Vitalipid Novum Adult

Dosage Form : INJ

Dosage Strength : 99mcg

Packaging : 10X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

KIVIPharm

China
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

KIVIPharm

China
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin D2

Brand Name :

Dosage Form : Injection

Dosage Strength : 10mg/mL

Packaging : Glass Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

blank

07

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Calcium; Phosphorus; Vitamin B12; Vitamin C; Vitamin D; Citric Acid

Brand Name : CAL-PV Powder

Dosage Form : Powder

Dosage Strength : 42MG; 15MG; 10MCG; 6MG; 400IU; 0.27G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Bangladesh

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08

SIFI

Italy
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

SIFI

Italy
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin A; Riboflavin; Ergocalciferolo; Pantothenic Acid

Brand Name : Xantervit

Dosage Form :

Dosage Strength : Heparin Oftalm Pom 5 G  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
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Pharma, Lab & Chemical Expo
Not Confirmed

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E

Brand Name : M.V.I.-12 LYOPHILIZED

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10MG/VIAL

Packaging :

Approval Date : 1985-08-08

Application Number : 18933

Regulatory Info : DISCN

Registration Country : USA

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Country
Pharma, Lab & Chemical Expo
Not Confirmed
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Country
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

ERGOCALCIFEROL

Brand Name : ERGOCALCIFEROL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50,000 IU

Packaging :

Approval Date : 2010-08-03

Application Number : 90455

Regulatory Info : RX

Registration Country : USA

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Listed Dossiers

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01

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Vitamin D

Brand Name :

Dosage Form : Soft Gel Capsule

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

01

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Vitamin D

Dosage : Soft Gel Capsule

Dosage Strength : 25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

02

Biofact Life

Malaysia
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

Biofact Life

Malaysia
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Calcium; Vitamin D

Brand Name : 1Q Gummy With Calcium ...

Dosage Form :

Dosage Strength : 99%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Malaysia

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02

Biofact Life

Malaysia
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

Biofact Life

Malaysia
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Calcium; Vitamin D

Dosage :

Dosage Strength : 99%

Brand Name : 1Q Gummy With Calcium ...

Approval Date :

Application Number :

Registration Country : Malaysia

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03

CP Bio

China
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

CP Bio

China
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin A; Vitamin D2; Vitamin E; Vitamin K1; Ascorbic Acid; Vitamin B1; Riboflavin; Niacin; Pyridoxine Hydrochloride; Folic Acid; Vitamin B12; Biotin; Pantothenic Acid; Calcium; Magnesium; Iron; Zinc; Copper; Mangan; Selenium; Chromium; Molybdenum; Iodine

Brand Name : Cogito® Kids C Plus

Dosage Form : Soft-Gum

Dosage Strength : 300MCG; 10MCG; 36MG; 5...

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Germany

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03

CP Bio

China
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

CP Bio

China
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin A; Vitamin D2; Vitamin E; Vitamin K1; Ascorbic Acid; Vitamin B1; Riboflavin; Niacin; Pyridoxine Hydrochloride; Folic Acid; Vitamin B12; Biotin; Pantothenic Acid; Calcium; Magnesium; Iron; Zinc; Copper; Mangan; Selenium; Chromium; Molybdenum; Iodine

Dosage : Soft-Gum

Dosage Strength : 300MCG; 10MCG; 36MG; 5...

Brand Name : Cogito® Kids C Plus

Approval Date :

Application Number :

Registration Country : Germany

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04

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
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Pharma, Lab & Chemical Expo
Not Confirmed

Glyoxyldiureide; Benzalkonium Chloride; Zinc Oxide; Fish Oil; Vitamin A; Vitamin D; Vitamin E

Brand Name : Avanta

Dosage Form : Ointment

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country :

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04

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Glyoxyldiureide; Benzalkonium Chloride; Zinc Oxide; Fish Oil; Vitamin A; Vitamin D; Vitamin E

Dosage : Ointment

Dosage Strength :

Brand Name : Avanta

Approval Date :

Application Number :

Registration Country :

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05

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin A; Vitamin E; Vitamin D; Vitamin B; Vitamin C; Selenium; Biotin; Lycine; Methionine

Brand Name : STRESSNOL

Dosage Form : Liquid

Dosage Strength : 160000IU; 150MG; 25000...

Packaging :

Approval Date :

Application Number : Vitamin C

Regulatory Info :

Registration Country : India

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05

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin A; Vitamin E; Vitamin D; Vitamin B; Vitamin C; Selenium; Biotin; Lycine; Methionine

Dosage : Liquid

Dosage Strength : 160000IU; 150MG; 25000...

Brand Name : STRESSNOL

Approval Date :

Application Number : Vitamin C

Registration Country : India

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06

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin D2

Brand Name :

Dosage Form : Injection

Dosage Strength : 10mg/mL

Packaging : Glass Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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06

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin D2

Dosage : Injection

Dosage Strength : 10mg/mL

Brand Name :

Approval Date :

Application Number :

Registration Country : China

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07

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin D

Brand Name : Mildê® drops 10ml

Dosage Form : Drops

Dosage Strength : 1,000IU/200,000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Brazil

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07

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin D

Dosage : Drops

Dosage Strength : 1,000IU/200,000IU

Brand Name : Mildê® drops 10ml

Approval Date :

Application Number :

Registration Country : Brazil

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08

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Calcium; Phosphorus; Vitamin B12; Vitamin C; Vitamin D; Citric Acid

Brand Name : CAL-PV Powder

Dosage Form : Powder

Dosage Strength : 42MG; 15MG; 10MCG; 6MG...

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Bangladesh

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08

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Calcium; Phosphorus; Vitamin B12; Vitamin C; Vitamin D; Citric Acid

Dosage : Powder

Dosage Strength : 42MG; 15MG; 10MCG; 6MG...

Brand Name : CAL-PV Powder

Approval Date :

Application Number :

Registration Country : Bangladesh

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09

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin C; Vitamin D; Zinc

Brand Name : Ceviforte C+D MAX

Dosage Form : Tablet

Dosage Strength : 1000MG; 2000IU; 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Poland

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09

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Vitamin C; Vitamin D; Zinc

Dosage : Tablet

Dosage Strength : 1000MG; 2000IU; 15MG

Brand Name : Ceviforte C+D MAX

Approval Date :

Application Number :

Registration Country : Poland

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10

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Calcium; Vitamin D

Brand Name : Calcium/Vitamin D

Dosage Form : Tablet

Dosage Strength : 600IU; 400IU

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Mexico

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10

Pharma, Lab & Chemical Expo
Not Confirmed
arrow
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Calcium; Vitamin D

Dosage : Tablet

Dosage Strength : 600IU; 400IU

Brand Name : Calcium/Vitamin D

Approval Date :

Application Number :

Registration Country : Mexico

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

USFDA APPLICATION NUMBER - 18920

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DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL

USFDA APPLICATION NUMBER - 21625

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DOSAGE - CAPSULE;ORAL - 50,000 IU

USFDA APPLICATION NUMBER - 3444

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DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

USFDA APPLICATION NUMBER - 8809

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ABOUT THIS PAGE

Vitamin D Manufacturers

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

Vitamin D Suppliers

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

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

Vitamin D USDMF

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

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

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

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

Vitamin D 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 Vitamin D as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Vitamin D GMP

Vitamin D 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 Vitamin D 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 Vitamin D GMP manufacturer or Vitamin D GMP API supplier for your needs.

Vitamin D CoA

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

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

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