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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
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
Molecular Weight | 386.5 g/mol |
---|---|
Molecular Formula | C24H34O4 |
XLogP3 | 4.1 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 3 |
Exact Mass | 386.24570956 g/mol |
Monoisotopic Mass | 386.24570956 g/mol |
Topological Polar Surface Area | 60.4 Ų |
Heavy Atom Count | 28 |
Formal Charge | 0 |
Complexity | 767 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 7 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 8 | |
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Drug Name | Depo-provera |
PubMed Health | Medroxyprogesterone |
Drug Classes | Antineoplastic Agent, Contraceptive, Contraceptive, Progestin, Endocrine-Metabolic Agent |
Drug Label | Depo-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 Ingredient | Medroxyprogesterone acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | 400mg/ml; 150mg/ml |
Market Status | Prescription |
Company | Pharmacia And Upjohn |
2 of 8 | |
---|---|
Drug Name | Depo-subq provera 104 |
PubMed Health | Medroxyprogesterone |
Drug Classes | Antineoplastic Agent, Contraceptive, Contraceptive, Progestin, Endocrine-Metabolic Agent |
Drug Label | Medroxyprogesterone 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 Ingredient | Medroxyprogesterone acetate |
Dosage Form | Injectable |
Route | suspension; Subcutaneous |
Strength | 104mg/0.65ml |
Market Status | Prescription |
Company | Pfizer; Pharmacia And Upjohn |
3 of 8 | |
---|---|
Drug Name | Medroxyprogesterone acetate |
Drug Label | depo-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 Ingredient | Medroxyprogesterone acetate |
Dosage Form | Tablet; Injectable |
Route | Injection; Oral |
Strength | 2.5mg; 150mg/ml; 5mg; 10mg |
Market Status | Prescription |
Company | Teva Pharms Usa; Sandoz; Barr |
4 of 8 | |
---|---|
Drug Name | Provera |
Active Ingredient | Medroxyprogesterone acetate |
Dosage Form | Tablet |
Route | Oral |
Strength | 2.5mg; 5mg; 10mg |
Market Status | Prescription |
Company | Pharmacia And Upjohn |
5 of 8 | |
---|---|
Drug Name | Depo-provera |
PubMed Health | Medroxyprogesterone |
Drug Classes | Antineoplastic Agent, Contraceptive, Contraceptive, Progestin, Endocrine-Metabolic Agent |
Drug Label | Depo-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 Ingredient | Medroxyprogesterone acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | 400mg/ml; 150mg/ml |
Market Status | Prescription |
Company | Pharmacia And Upjohn |
6 of 8 | |
---|---|
Drug Name | Depo-subq provera 104 |
PubMed Health | Medroxyprogesterone |
Drug Classes | Antineoplastic Agent, Contraceptive, Contraceptive, Progestin, Endocrine-Metabolic Agent |
Drug Label | Medroxyprogesterone 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 Ingredient | Medroxyprogesterone acetate |
Dosage Form | Injectable |
Route | suspension; Subcutaneous |
Strength | 104mg/0.65ml |
Market Status | Prescription |
Company | Pfizer; Pharmacia And Upjohn |
7 of 8 | |
---|---|
Drug Name | Medroxyprogesterone acetate |
Drug Label | depo-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 Ingredient | Medroxyprogesterone acetate |
Dosage Form | Tablet; Injectable |
Route | Injection; Oral |
Strength | 2.5mg; 150mg/ml; 5mg; 10mg |
Market Status | Prescription |
Company | Teva Pharms Usa; Sandoz; Barr |
8 of 8 | |
---|---|
Drug Name | Provera |
Active Ingredient | Medroxyprogesterone acetate |
Dosage Form | Tablet |
Route | Oral |
Strength | 2.5mg; 5mg; 10mg |
Market Status | Prescription |
Company | Pharmacia And Upjohn |
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
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.
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.)
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.
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
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.
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.
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
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