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Also known as: Medroxyprogesterone 17-acetate, 71-58-9, Provera, Metigestrona, Depo-provera, Farlutin
Molecular Formula
C24H34O4
Molecular Weight
386.5  g/mol
InChI Key
PSGAAPLEWMOORI-PEINSRQWSA-N
FDA UNII
C2QI4IOI2G

Medroxyprogesterone Acetate
A synthetic progestin that is derived from 17-hydroxyprogesterone. It is a long-acting contraceptive that is effective both orally or by intramuscular injection and has also been used to treat breast and endometrial neoplasms.
1 2D Structure

Medroxyprogesterone Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(6S,8R,9S,10R,13S,14S,17R)-17-acetyl-6,10,13-trimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] acetate
2.1.2 InChI
InChI=1S/C24H34O4/c1-14-12-18-19(22(4)9-6-17(27)13-21(14)22)7-10-23(5)20(18)8-11-24(23,15(2)25)28-16(3)26/h13-14,18-20H,6-12H2,1-5H3/t14-,18+,19-,20-,22+,23-,24-/m0/s1
2.1.3 InChI Key
PSGAAPLEWMOORI-PEINSRQWSA-N
2.1.4 Canonical SMILES
CC1CC2C(CCC3(C2CCC3(C(=O)C)OC(=O)C)C)C4(C1=CC(=O)CC4)C
2.1.5 Isomeric SMILES
C[C@H]1C[C@@H]2[C@H](CC[C@]3([C@H]2CC[C@@]3(C(=O)C)OC(=O)C)C)[C@@]4(C1=CC(=O)CC4)C
2.2 Other Identifiers
2.2.1 UNII
C2QI4IOI2G
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (6 Alpha)-17-(acetoxy)-6-methylpregn-4-ene-3,20-dione

2. 6 Alpha Methyl 17alpha Hydroxyprogesterone Acetate

3. 6-alpha-methyl-17alpha-hydroxyprogesterone Acetate

4. Curretab

5. Cycrin

6. Depo Medroxyprogesterone Acetate

7. Depo Provera

8. Depo-medroxyprogesterone Acetate

9. Depo-provera

10. Depoprovera

11. Farlutal

12. Gestapuran

13. Medroxyprogesterone 17 Acetate

14. Medroxyprogesterone 17-acetate

15. Medroxyprogesterone 17-acetate, (6 Alpha,17 Alpha)-isomer

16. Medroxyprogesterone 17-acetate, (6 Beta)-isomer

17. Perlutex

18. Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6alpha)-

19. Provera

20. Veramix

2.3.2 Depositor-Supplied Synonyms

1. Medroxyprogesterone 17-acetate

2. 71-58-9

3. Provera

4. Metigestrona

5. Depo-provera

6. Farlutin

7. Gestapuran

8. Perlutex

9. Veramix

10. Methylacetoxyprogesterone

11. Amen

12. Medroxyacetate Progesterone

13. Clinovir

14. Depcorlutin

15. Deporone

16. Lutopolar

17. Nadigest

18. Prodasone

19. Progestalfa

20. Progevera

21. Proverone

22. Repromix

23. Sirprogen

24. Supprestral

25. Nidaxin

26. Oragest

27. Depo-promone

28. Promone-e

29. Nsc-26386

30. 6-alpha-methyl-17-alpha-acetoxyprogesterone

31. Cycrin

32. Medroxyprogesteroneacetate

33. Depo-subq Provera 104

34. Depot-medroxyprogesterone Acetate

35. 6-alpha-methyl-17-alpha-hydroxyprogesterone Acetate

36. 17alpha-hydroxy-6alpha-methylprogesterone Acetate

37. 6alpha-methyl-17alpha-hydroxyprogesterone Acetate

38. 6alpha-methyl-4-pregnene-3,20-dion-17alpha-ol Acetate

39. Depot Medroxyprogesterone Acetate

40. Dp150

41. Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6alpha)-

42. 17-acetoxy-6alpha-methylprogesterone

43. Aragest

44. Ralovera

45. 6alpha-methyl-17-acetoxy Progesterone

46. Hysron

47. Provera Dosepak

48. Depo-clinovir

49. Depo-ralovera

50. (6alpha)-6-methyl-3,20-dioxopregn-4-en-17-yl Acetate

51. Nsc-21171

52. U 8839

53. C2qi4ioi2g

54. Medroxyprogesterone (acetate)

55. Mls000069442

56. (6alpha)-17-(acetyloxy)-6-methylpreg-4-ene-3,20-dione

57. Chebi:6716

58. Onco-provera

59. Map

60. Medrosterona

61. Clinofem

62. Cykrina

63. Depocon

64. Indivina

65. Mepastat

66. Meprate

67. Repromap

68. Smr000059125

69. Sumiferm

70. Suprestral

71. Tv-46046

72. Veraplex

73. Dugen

74. Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6a)-

75. Depo-progestin

76. Depo-prodasone

77. Depo-progevera

78. Perlutex Leo

79. Dsstox_cid_5527

80. Depo-map

81. Aragest 5

82. Med-pro

83. Mpa-beta

84. Dsstox_rid_77819

85. Mpa Hexal

86. Mpa-noury

87. Dsstox_gsid_25527

88. [(6s,8r,9s,10r,13s,14s,17r)-17-acetyl-6,10,13-trimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-17-yl] Acetate

89. Map (steroid)

90. 17alpha-acetoxy-6alpha-methylprogesterone

91. 6alpha-methyl-17alpha-acetoxyprogesterone

92. Depomedroxyprogesterone Acetate

93. Mpa Gym

94. Depo-medroxyprogesterone Acetate

95. Depo-subq Provera

96. Cas-71-58-9

97. Ccris 371

98. 17.alpha.-acetoxy-6.alpha.-methylprogesterone

99. Medroxyprogesterone Acetate [jan]

100. Einecs 200-757-9

101. Unii-c2qi4ioi2g

102. 6alpha-methyl-17-acetoxyprogesterone

103. Nsc 21171

104. Depo-provera Contraceptive

105. 17-acetoxy-6-alpha-methylprogesterone

106. (6.alpha.-pregn-4-ene-3, 17-(acetyloxy)-6-methyl-

107. 17.alpha.-hydroxy-6-.alpha.-methylprogesterone Acetate

108. Pregn-4-ene-3, 17-hydroxy-6.alpha.-methyl-, Acetate

109. 6-alpha-methyl-17-acetoxy Progesterone

110. Brn 2066112

111. Pregn-4-ene-3, 17-(acetyloxy)-6-methyl-, (6.alpha.)-

112. Medroxyprogesterone-17-acetate

113. Ai3-60127

114. Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6.alpha.)-

115. 17-acetoxy-6.alpha.-methylprogesterone

116. 6.alpha.-methyl-17-acetoxyprogesterone

117. Ncgc00094713-01

118. 17alpha-hydroxy-6-alpha-methylprogesterone Acetate

119. Progesterone, 17-hydroxy-6alpha-methyl-, Acetate

120. 17-alpha-hydroxy-6-alpha-methylprogesterone Acetate

121. Provera (tn)

122. Depo-provera (tn)

123. 6alpha-methyl-17alpha-acetoxypregn-4-ene-3,20-dione

124. Medroxyprogesterone Acetate [usp:jan]

125. 17-alpha-acetoxy-6-alpha-methylpregn-4-ene-3,20-dione

126. 17alpha-acetoxy-6-alpha-methylpregn-4-ene-3,20-dione

127. 6-alpha-methyl-17-alpha-acetoxypregn-4-ene-3,20-dione

128. Progesterone, 17-alpha-hydroxy-6-alpha-methyl-, Acetate

129. Medroxyprogesterone Acetate [progestins]

130. 6-alpha-methyl-4-pregnene-3,20-dion-17-alpha-ol Acetate

131. 6.alpha.-methyl-17.alpha.-acetoxyprogesterone

132. (6-alpha)-17-(acetyloxy)-6-methylpreg-4-ene-3,20-dione

133. 17alpha-hydroxy-6alpha-methylpregn-4-ene-3,20-dione Acetate

134. 6alpha-pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-

135. Cpd000653524

136. 17-alpha-hydroxy-6-alpha-methylpregn-4-ene-3,20-dione Acetate

137. Medroxyprogesteroni Acetas

138. Opera_id_1110

139. Medroxyprogesterone-acetate

140. 17.alpha.-hydroxy-6.alpha.-methylprogesterone Acetate

141. 6.alpha.-methyl-17.alpha.-hydroxyprogesterone Acetate

142. Medroxiprogesterone Acetate

143. Chembl717

144. Schembl4276

145. 6.alpha.-methyl-17.alpha.-acetoxypregn-4-ene-3,20-dione

146. 17.alpha.-acetoxy-6-.alpha.-methylpregn-4-ene-3,20-dione

147. 4-08-00-02212 (beilstein Handbook Reference)

148. 6.alpha.-methyl-4-pregnene-3,20-dion-17.alpha.-ol Acetate

149. Mls001148217

150. Mls002207115

151. 17.alpha.-hydroxy-6.alpha.-methylpregn-4-ene-3,20-dione Acetate

152. Depo-subq Provera 104 (tn)

153. Dtxsid0025527

154. Hms2233o07

155. Hms2235e05

156. Hms3259o14

157. Hms3884b10

158. Pregn-4-ene-3,20-dione, 17-hydroxy-6alpha-methyl-, Acetate

159. (6-alpha)-pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-

160. (6s,8r,9s,10r,13s,14s,17r)-17-acetyl-6,10,13-trimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl Acetate

161. Cbp-1011

162. Hy-b0469

163. Nsc21171

164. Nsc26386

165. Zinc5029557

166. Tox21_111319

167. Tox21_200141

168. Bdbm50067678

169. S2567

170. Akos015894870

171. Tox21_111319_1

172. Ac-2174

173. Ccg-264965

174. Db00603

175. Nc00574

176. Medroxyprogesterone Acetate (jp17/usp)

177. Mrf-0000023

178. Ncgc00022037-03

179. Ncgc00022037-04

180. Ncgc00022037-05

181. Ncgc00022037-07

182. Ncgc00257695-01

183. Ncgc00263480-01

184. As-13981

185. Medroxyprogesterone Acetate [iarc]

186. Smr000653524

187. Medroxyprogesterone Acetate [mart.]

188. Medroxyprogesterone Acetate [vandf]

189. Medroxyprogesterone 17-acetate [mi]

190. Medroxyprogesterone Acetate [usp-rs]

191. Medroxyprogesterone Acetate [who-dd]

192. Medroxyprogesterone Acetate [who-ip]

193. C08150

194. C76275

195. D00951

196. Ab00384270-14

197. Ab00384270_15

198. Medroxyprogesterone 17-acetate, >=97% (hplc)

199. Medroxyprogesterone Acetate [orange Book]

200. Medroxyprogesteroni Acetas [who-ip Latin]

201. 010m483

202. Medroxyprogesterone Acetate [ep Monograph]

203. Medroxyprogesterone Acetate [usp Monograph]

204. Megestrol Acetate Impurity A [ep Impurity]

205. Lunelle Component Medroxyprogesterone Acetate

206. Prempro Component Medroxyprogesterone Acetate

207. Q2823834

208. (6?)-6-methyl-3,20-dioxopregn-4-en-17-yl Acetate

209. 6.alpha.-pregn-4-ene-3, 17-(acetyloxy)-6-methyl-

210. Medroxyprogesterone Acetate Component Of Lunelle

211. Medroxyprogesterone Acetate Component Of Prempro

212. Premphase Component Medroxyprogesterone Acetate

213. Medroxyprogesterone Acetate Component Of Premphase

214. Medroxyprogesterone 17-acetate 100 Microg/ml In Methanol/water

215. Medroxyprogesterone-17-acetate 100 Microg/ml In Acetonitrile

216. 17-hydroxy-6.alpha.-methylpregn-4-ene-3,20-dione Acetate

217. Medroxyprogesterone 17-acetate, Vetranal(tm), Analytical Standard

218. Medroxyprogesterone Acetate, European Pharmacopoeia (ep) Reference Standard

219. Medroxyprogesterone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material

220. Medroxyprogesterone Acetate, United States Pharmacopeia (usp) Reference Standard

221. Medroxyprogesterone Acetate For Peak Identification, European Pharmacopoeia (ep) Reference Standard

222. Medroxyprogesterone Acetate For System Suitability, European Pharmacopoeia (ep) Reference Standard

223. Medroxyprogesterone Acetate, For Performance Test, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 386.5 g/mol
Molecular Formula C24H34O4
XLogP34.1
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count4
Rotatable Bond Count3
Exact Mass386.24570956 g/mol
Monoisotopic Mass386.24570956 g/mol
Topological Polar Surface Area60.4 Ų
Heavy Atom Count28
Formal Charge0
Complexity767
Isotope Atom Count0
Defined Atom Stereocenter Count7
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 8  
Drug NameDepo-provera
PubMed HealthMedroxyprogesterone
Drug ClassesAntineoplastic Agent, Contraceptive, Contraceptive, Progestin, Endocrine-Metabolic Agent
Drug LabelDepo-Provera CI contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline...
Active IngredientMedroxyprogesterone acetate
Dosage FormInjectable
RouteInjection
Strength400mg/ml; 150mg/ml
Market StatusPrescription
CompanyPharmacia And Upjohn

2 of 8  
Drug NameDepo-subq provera 104
PubMed HealthMedroxyprogesterone
Drug ClassesAntineoplastic Agent, Contraceptive, Contraceptive, Progestin, Endocrine-Metabolic Agent
Drug LabelMedroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210It is freely soluble in chloroform, sol...
Active IngredientMedroxyprogesterone acetate
Dosage FormInjectable
Routesuspension; Subcutaneous
Strength104mg/0.65ml
Market StatusPrescription
CompanyPfizer; Pharmacia And Upjohn

3 of 8  
Drug NameMedroxyprogesterone acetate
Drug Labeldepo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white, odorless...
Active IngredientMedroxyprogesterone acetate
Dosage FormTablet; Injectable
RouteInjection; Oral
Strength2.5mg; 150mg/ml; 5mg; 10mg
Market StatusPrescription
CompanyTeva Pharms Usa; Sandoz; Barr

4 of 8  
Drug NameProvera
Active IngredientMedroxyprogesterone acetate
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg; 10mg
Market StatusPrescription
CompanyPharmacia And Upjohn

5 of 8  
Drug NameDepo-provera
PubMed HealthMedroxyprogesterone
Drug ClassesAntineoplastic Agent, Contraceptive, Contraceptive, Progestin, Endocrine-Metabolic Agent
Drug LabelDepo-Provera CI contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline...
Active IngredientMedroxyprogesterone acetate
Dosage FormInjectable
RouteInjection
Strength400mg/ml; 150mg/ml
Market StatusPrescription
CompanyPharmacia And Upjohn

6 of 8  
Drug NameDepo-subq provera 104
PubMed HealthMedroxyprogesterone
Drug ClassesAntineoplastic Agent, Contraceptive, Contraceptive, Progestin, Endocrine-Metabolic Agent
Drug LabelMedroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210It is freely soluble in chloroform, sol...
Active IngredientMedroxyprogesterone acetate
Dosage FormInjectable
Routesuspension; Subcutaneous
Strength104mg/0.65ml
Market StatusPrescription
CompanyPfizer; Pharmacia And Upjohn

7 of 8  
Drug NameMedroxyprogesterone acetate
Drug Labeldepo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white, odorless...
Active IngredientMedroxyprogesterone acetate
Dosage FormTablet; Injectable
RouteInjection; Oral
Strength2.5mg; 150mg/ml; 5mg; 10mg
Market StatusPrescription
CompanyTeva Pharms Usa; Sandoz; Barr

8 of 8  
Drug NameProvera
Active IngredientMedroxyprogesterone acetate
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg; 10mg
Market StatusPrescription
CompanyPharmacia And Upjohn

4.2 Drug Indication

Medroxyprogesterone acetate (MPA) oral tablets are indicated to treat secondary amenorrhea, reduce the incidence of endometrial hyperplasia in postmenopausal women, and to treat abnormal uterine bleeding due to hormonal imbalance, not organic pathology. Oral tablets containing MPA and conjugated estrogens are indicated to prevent postmenopausal osteoporosis and to treat moderate to severe menopausal symptoms such as vasomotor symptoms, vulvar atrophy, and vaginal atrophy. Subcutaneous MPA is indicated to prevent pregnancy and manage pain associated with endometriosis. Intramuscular MPA is indicated to prevent pregnancy, and at higher concentrations for palliative treatment of endometrial or renal carcinoma.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Medroxyprogesterone acetate (MPA) inhibits gonadotropin production, reduces nuclear estrogen receptors and DNA synthesis in epithelial cells of the endometrium, and induces p53 dependant apoptosis in cancer cell lines. MPA oral tablets have a half life of 40-60 hours and other formulations can have half lives that are considerably longer, so the duration of action is long. The therapeutic window is wide as patients may take doses ranging from 5mg orally daily to 1000mg as a depo injection weekly. Long term use of MPA is associated with a reduction in bone density and patients who taking MPA during adolescence may have lower peak bone mass than untreated patients, which can also increase the risk of osteoporosis and fractures in the future.


5.2 MeSH Pharmacological Classification

Contraceptive Agents, Female

Chemical substances or agents with contraceptive activity in females. Use for female contraceptive agents in general or for which there is no specific heading. (See all compounds classified as Contraceptive Agents, Female.)


Contraceptive Agents, Male

Chemical substances or agents with contraceptive activity in males. Use for male contraceptive agents in general or for which there is no specific heading. (See all compounds classified as Contraceptive Agents, Male.)


Antineoplastic Agents, Hormonal

Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)


Contraceptive Agents, Hormonal

Contraceptive agents that act on the ENDOCRINE SYSTEM. (See all compounds classified as Contraceptive Agents, Hormonal.)


5.3 FDA Pharmacological Classification
5.3.1 Pharmacological Classes
Progestin [EPC]; Progesterone Congeners [CS]
5.4 Absorption, Distribution and Excretion

Absorption

Absorption of oral medroxyprogesterone acetate (MPA) varies considerably between formulations. A 1000mg oral dose reaches an average Cmax of 145-315nmol/L while a 500mg oral dose reaches an average Cmax of 33-178nmol/L with a Tmax of 1-3 hours and a lag time of half an hour. The AUC of a 500mg oral dose of MPA was 543.4-1981.1nmol\*L/h depending on formulation. Intramuscular MPA reaches a Cmax of 4.691.52nmol/L with a Tmax of 4.752.09 days and an AUC of 81.5827.64days\*nmol/L. Subcutaneous MPA reaches a Cmax of 3.831.56nmol/L with a Tmax of 6.522.07 days and an AUC of 72.2638.73days\*nmol/L. However, the pharmacokinetics of MPA may also vary depending on injection site.


Route of Elimination

The majority of medroxyprogesterone acetate (MPA) is eliminated in the urine as glucuronide conjugates and a minority of sulphate conjugates. Glucuronide conjugates are also detected in the feces. Determining the exact ratio of metabolites and parent compound eliminated in the urine and feces is difficult as the metabolite profile in the urine is not significantly different and radio labelling studies are not readily available.


Volume of Distribution

The volume of distribution of medroxyprogesterone acetate is 203L.


Clearance

The mean clearance of medroxyprogesterone acetate (MPA) is 1668146L/day or 21.94.3L/kg/day. Due to the high inter patient variability in MPA pharmacokinetics, clearance has been reported to be 1600-4000L/day.


5.5 Metabolism/Metabolites

Medroxyprogesterone acetate undergoes beta hydroxylation to form the metabolites 6-beta (M-2), 2-beta (M-4), and 1-beta-hydroxymedroxyprogesterone acetate (M-3). M-2 and M-4 are further metabolized to 2-beta,6-beta-dihydroxymedroxyprogesterone (M-1). M-3 is further metabolized to 1,2-dehydromedroxyprogesterone acetate (M-5).


Medroxyprogesterone Acetate has known human metabolites that include M-2, M-3, and Medroxyprogesterone Acetate.

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


5.6 Biological Half-Life

Oral medroxyprogesterone acetate (MPA) has an absorption half life of 15-30min and a biological half life of 40-60 hours. Intramuscular MPA has an absorption half life of 0.860.30 days and an elimination half life of 24.0321.74 days. Subcutaneous MPA has an absorption half life of 1.050.56 days and an elimination half life of 30.9015.11 days.


5.7 Mechanism of Action

Medroxyprogesterone acetate (MPA) inhibits the production of gonadotropin, preventing follicular maturation and ovulation, which is responsible for its ability to prevent pregnancy. This action also thins the endometrium. MPA reduces nuclear estrogen receptors and DNA synthesis in epithelial cells of the endometrium. MPA can also induce p53 dependant apoptosis in certain cancer cell lines, and inhibit GABA-A receptors.


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PHARMA","customerCountry":"INDIA","quantity":"18.72","actualQuantity":"18.72","unit":"KGS","unitRateFc":"240","totalValueFC":"4536","currency":"USD","unitRateINR":"20448","date":"12-Nov-2024","totalValueINR":"382786.56","totalValueInUsd":"4536","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"6627143","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ROOM 302 NO.22 CHANGCHENG STREET GO NGSHU DISTRICT HANGZHOU CHINA SDNF CHINA","customerAddress":"30 ABHISHEK AVENUE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732041000,"product":"MEDROXYPROGESTERONE ACETATE USP","address":"515 MODERN INDUSTRIAL ESTATE","city":"BAHADURGARH","supplier":"TIANJIN FENGHE PHARMACEUTICALS CO.,LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"BELCO PHARMA","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"360","totalValueFC":"10916.7","currency":"USD","unitRateINR":"30708","date":"20-Nov-2024","totalValueINR":"921240","totalValueInUsd":"10916.7","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"6774385","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"14-1-202 YANG LIU QING LIU YUAN, XIQING DISTRICT, TIANJIN,, CHINA","customerAddress":"515 MODERN INDUSTRIAL ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732127400,"product":"MEDROXYPROGESTERONE ACETATE (D.I.LIC NO.IL\/BD-012903 RC\/BD-002643)","address":"108, MARINE CHEMBERS, 43, NEW","city":"MUMBAI","supplier":"WUHAN JIULONG PHARMACEUTICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"B.M. CHEMIE","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"330","totalValueFC":"25017.4","currency":"USD","unitRateINR":"28149","date":"21-Nov-2024","totalValueINR":"2111175","totalValueInUsd":"25017.4","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"6790611","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.77, OPTICS VALLEY SEVENTH ROAD, EAST LAKE HIGH-TECH DISTRICT, WHUHA N 430206 HUBEI, , CHINA CHINA","customerAddress":"108, MARINE CHEMBERS, 43, NEW"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734028200,"product":"MEDROXYPROGESTERONE ACETATE CHEMICALS","address":"NO.18,DR NAIR ROAD, T NAGAR,","city":"CHENNAI","supplier":"TAPI TECHNOLOGY & API SERVICES","supplierCountry":"NETHERLANDS","foreign_port":"MEXICO CITY","customer":"STERIL-GENE LIFE SCIENCES (P) LTD","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"1150","totalValueFC":"23184.3","currency":"USD","unitRateINR":"98497.5","date":"13-Dec-2024","totalValueINR":"1969950","totalValueInUsd":"23184.3","indian_port":"Madras Air","hs_no":"29420090","bill_no":"7214186","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"PIET HEIN 107 1019 GM AMSTERDAM THE NETHERLANDS NETHERLANDS","customerAddress":"NO.18,DR NAIR ROAD, T NAGAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735151400,"product":"MEDROXYPROGESTERONE ACETATE (D.I.LIC NO.IL\/BD-012903 RC\/BD-002643)MEDROXYPROGESTERONE ACETATE (D.I.LIC NO.IL\/BD-012903 RC\/BD-0","address":"108, MARINE CHEMBERS, 43, NEW","city":"MUMBAI","supplier":"WUHAN JIULONG PHARMACEUTICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"B.M. 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11-Feb-2021
27-Dec-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 11839

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DOSAGE - TABLET;ORAL - 2.5MG

USFDA APPLICATION NUMBER - 11839

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 11839

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DOSAGE - INJECTABLE;INJECTION - 100MG/ML **Fe...DOSAGE - INJECTABLE;INJECTION - 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 12541

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DOSAGE - INJECTABLE;INJECTION - 400MG/ML

USFDA APPLICATION NUMBER - 12541

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DOSAGE - INJECTABLE;INJECTION - 150MG/ML

USFDA APPLICATION NUMBER - 20246

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ABOUT THIS PAGE

Medroxyprogesterone Acetate Manufacturers

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

Medroxyprogesterone Acetate Suppliers

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

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

Medroxyprogesterone Acetate USDMF

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

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

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

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

Medroxyprogesterone Acetate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Medroxyprogesterone Acetate Drug Master File in Korea (Medroxyprogesterone Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Medroxyprogesterone Acetate. The MFDS reviews the Medroxyprogesterone Acetate KDMF as part of the drug registration process and uses the information provided in the Medroxyprogesterone Acetate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Medroxyprogesterone Acetate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Medroxyprogesterone Acetate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Medroxyprogesterone Acetate suppliers with KDMF on PharmaCompass.

Medroxyprogesterone Acetate CEP

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

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

Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Medroxyprogesterone Acetate GMP

Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate GMP manufacturer or Medroxyprogesterone Acetate GMP API supplier for your needs.

Medroxyprogesterone Acetate CoA

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

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

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