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1. 5-(4-(2-(5-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione
2. Actos
3. Ad 4833
4. Ad-4833
5. Ad4833
6. Pioglitazone
7. U 72107a
8. U-72107a
9. U72,107a
10. U72107a
1. 112529-15-4
2. Pioglitazone Hcl
3. Actos
4. Piomed
5. 5-(4-(2-(5-ethylpyridin-2-yl)ethoxy)benzyl)thiazolidine-2,4-dione Hydrochloride
6. U-72107a
7. Pioglitazone (hydrochloride)
8. Ad 4833
9. U 72107a
10. Jqt35npk6c
11. U-72107e
12. Pioglitazone (as Hydrochloride)
13. Str-001
14. [5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] Thiazolidinedione Hydrochloride
15. Nsc-758876
16. Ncgc00095131-01
17. Pioditazone Hydrochloride
18. 5-[4-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl]thiazolidine-2,4-dione Hydrochloride
19. Actos (tn)
20. Dsstox_cid_24203
21. Dsstox_rid_80116
22. Dsstox_gsid_44203
23. 5-[[4-[2-(5-ethylpyridin-2-yl)ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione;hydrochloride
24. 2,4-thiazolidinedione, 5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-, Monohydrochloride
25. Smr000469167
26. Cas-112529-15-4
27. Pioglitazone Hydrochloride [usan]
28. Unii-jqt35npk6c
29. 5-(4-[2-(5-ethyl-pyridin-2-yl)-ethoxy]-benzyl)-thiazolidine-2,4-dione Hydrochloride
30. 5-[4-[2-(5-ethyl-pyridin-2-yl)-ethoxy]-benzyl]-thiazolidine-2,4-dione Hydrochloride
31. 5-{4-[2-(5-ethyl-pyridin-2-yl)-ethoxy]-benzyl}-thiazolidine-2,4-dione Hydrochloride
32. 2,4-thiazolidinedione, 5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-, Monohydrochloride
33. Mfcd04975446
34. Poze
35. Pioglitazone Hydrochloride [usan:usp]
36. Pioglitazone Cloridrato
37. Pioglitazonehydrochloride
38. Cloridrato De Pioglitazona
39. Pioglitazone, Hydrochloride
40. Clorhidrato De Pioglitazona
41. Chlorhydrate De Pioglitazone
42. (+-)-5-(p-(2-(5-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione Monohydrochloride
43. 5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione Monohydrochloride
44. Chembl1715
45. Schembl21843
46. Mls001306462
47. Mls001401386
48. Spectrum1504401
49. Chebi:8229
50. Dtxsid3044203
51. Pioglitazone Hcl [vandf]
52. Pioglitazone Hydrochloride ,(s)
53. Pioglitazone Hydrochloride- Bio-x
54. Hms1922l05
55. Pioglitazone Hydrochloride (actos)
56. Act04238
57. Bcp22942
58. Tox21_111440
59. Tox21_300584
60. Ccg-39097
61. S2046
62. Akos015844016
63. Tox21_111440_1
64. Ac-1037
65. Ccg-100931
66. Ks-1186
67. Nc00181
68. Nsc 758876
69. Pioglitazone Hydrochloride (jp17/usp)
70. Pioglitazone Hydrochloride [mi]
71. Sb17324
72. Pioglitazone Hydrochloride [jan]
73. Ncgc00095131-02
74. Ncgc00163128-08
75. Ncgc00254492-01
76. 2,4-thiazolidinedione, 5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-, Monohydrochloride, (+-)-
77. Aa-10090
78. Bp164272
79. Hy-14601
80. Pioglitazone Hydrochloride [mart.]
81. Pioglitazone Hydrochloride [vandf]
82. Bcp0726000151
83. Pioglitazone Hydrochloride [usp-rs]
84. Pioglitazone Hydrochloride [who-dd]
85. Pioglitazone Hydrochloride, >=98% (hplc)
86. Am20061770
87. Ft-0601607
88. P1901
89. Sw197561-4
90. D00945
91. Pioglitazone Hydrochloride [orange Book]
92. Oseni Component Pioglitazone Hydrochloride
93. Pioglitazone Hydrochloride [ep Monograph]
94. 025p468
95. A802593
96. Duetact Component Pioglitazone Hydrochloride
97. Pioglitazone Hydrochloride [usp Monograph]
98. Pioglitazone Hydrochloride Component Of Oseni
99. Q-201584
100. Pioglitazone Hydrochloride 100 Microg/ml In Methanol
101. Pioglitazone Hydrochloride Component Of Duetact
102. Q27281642
103. Actoplus Met Component Pioglitazone Hydrochloride
104. Pioglitazone Hydrochloride Component Of Actoplus Met
105. 5-(4-(2-(5-ethylpyridin-2-yl)ethoxy)benzyl)thiazolidine-2,4-dione Hcl
106. Pioglitazone Hydrochloride, European Pharmacopoeia (ep) Reference Standard
107. 5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-2,4-thiazolidinedione, Hcl
108. 5-(4-[2-(5-ethyl-pyridin-2-yl)-ethoxy]-benzyl)-thiazolidine-2,4-dione Hcl
109. 5-[[4-[2-(5-ethyl-2-pyridinyl)-ethoxy]phenyl]methyl]-2,4-thiazolidinedione Hydrochloride
110. 5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, Hydrochloride
111. 5-[4-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl]-2,4-thiazolidinedione Hydrochloride
112. 5-{4-[2-(5-ethylpyridin-2-yl)ethoxy]benzyl}-1,3-thiazolidine-2,4-dione Hydrochloride
113. Pioglitazone For System Suitability, European Pharmacopoeia (ep) Reference Standard
114. Pioglitazone Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
115. Pioglitazone Hydrochloride, United States Pharmacopeia (usp) Reference Standard
116. (+/-)-5-(p-(2-(5-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione Monohydrochloride
117. 127676-30-6
118. 2,4-thiazolidinedione, 5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-, Hydrochloride (1:1)
119. 2,4-thiazolidinedione, 5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-, Monohydrochloride, (+/-)-
| Molecular Weight | 392.9 g/mol |
|---|---|
| Molecular Formula | C19H21ClN2O3S |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 7 |
| Exact Mass | 392.0961414 g/mol |
| Monoisotopic Mass | 392.0961414 g/mol |
| Topological Polar Surface Area | 93.6 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 466 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Pioglitazone hydrochloride |
| Drug Label | ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. ACTOS is used in the management of type2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adul... |
| Active Ingredient | Pioglitazone hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 15mg base; eq 30mg base; eq 45mg base |
| Market Status | Prescription |
| Company | Synthon Pharms; Mylan Pharms; Accord Hlthcare; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Sandoz; Watson Labs; Macleods Pharms; Zydus Pharms Usa; Dr Reddys Labs |
| 2 of 2 | |
|---|---|
| Drug Name | Pioglitazone hydrochloride |
| Drug Label | ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. ACTOS is used in the management of type2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adul... |
| Active Ingredient | Pioglitazone hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 15mg base; eq 30mg base; eq 45mg base |
| Market Status | Prescription |
| Company | Synthon Pharms; Mylan Pharms; Accord Hlthcare; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Sandoz; Watson Labs; Macleods Pharms; Zydus Pharms Usa; Dr Reddys Labs |
Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:
- as
* monotherapy: :
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
- as
* dual oral therapy: in combination with:
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
- as
* triple oral therapy: in combination with:
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus as
* monotherapy: :
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:
* as monotherapy:
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
* as monotherapy:
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
* as dual oral therapy in combination with:
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
* as triple oral therapy in combination with:
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4. 4).
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4. 4).
Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:
- as monotherapy
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance
- as dual oral therapy in combination with
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea
- as triple oral therapy in combination with
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:
- as monotherapy:
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;
- as dual oral therapy in combination with:
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
- as triple oral therapy in combination with:
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:
- as
* monotherapy: :
- in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;
- as
* dual oral therapy: in combination with:
- metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
- a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
- as
* triple oral therapy: in combination with:
- metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
* as monotherapy:
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;
as
* dual oral therapy: in combination with
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
as
* triple oral therapy: in combination with
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
as monotherapy
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;
as dual oral therapy in combination with
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone is indicated as second- or third-line treatment of type-2 diabetes mellitus as described below:
* as monotherapy: :
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;
* as dual oral therapy in combination with: :
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
* as triple oral therapy in combination with: :
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type-2-diabetes-mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4. 4).
After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e. g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4. 4).
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
A10BG03
A10BG03
A10BG03
A10BG03
A10BG03
A10BG03
A10BG03
A10BG03
A10BG03
A10BG03
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DOSAGE - TABLET;ORAL - EQ 15MG BASE
USFDA APPLICATION NUMBER - 21073
DOSAGE - TABLET;ORAL - EQ 30MG BASE
USFDA APPLICATION NUMBER - 21073
DOSAGE - TABLET;ORAL - EQ 45MG BASE
USFDA APPLICATION NUMBER - 21073
DOSAGE - TABLET;ORAL - 500MG;EQ 15MG BASE **F...DOSAGE - TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21842
DOSAGE - TABLET;ORAL - 850MG;EQ 15MG BASE
USFDA APPLICATION NUMBER - 21842
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE
USFDA APPLICATION NUMBER - 22024
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE
USFDA APPLICATION NUMBER - 22024
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PharmaCompass offers a list of Pioglitazone Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Pioglitazone Hydrochloride manufacturer or Pioglitazone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pioglitazone Hydrochloride manufacturer or Pioglitazone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Pioglitazone Hydrochloride API Price utilized in the formulation of products. Pioglitazone Hydrochloride API Price is not always fixed or binding as the Pioglitazone Hydrochloride Price is obtained through a variety of data sources. The Pioglitazone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pioglitazone HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pioglitazone HCl, including repackagers and relabelers. The FDA regulates Pioglitazone HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pioglitazone HCl 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 Pioglitazone HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pioglitazone HCl supplier is an individual or a company that provides Pioglitazone HCl active pharmaceutical ingredient (API) or Pioglitazone HCl finished formulations upon request. The Pioglitazone HCl suppliers may include Pioglitazone HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Pioglitazone HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pioglitazone HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Pioglitazone HCl active pharmaceutical ingredient (API) in detail. Different forms of Pioglitazone HCl DMFs exist exist since differing nations have different regulations, such as Pioglitazone HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pioglitazone HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Pioglitazone HCl USDMF includes data on Pioglitazone HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pioglitazone HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pioglitazone HCl 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 Pioglitazone HCl Drug Master File in Japan (Pioglitazone HCl JDMF) empowers Pioglitazone HCl 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 Pioglitazone HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Pioglitazone HCl 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 Pioglitazone HCl 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 Pioglitazone HCl Drug Master File in Korea (Pioglitazone HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pioglitazone HCl. The MFDS reviews the Pioglitazone HCl KDMF as part of the drug registration process and uses the information provided in the Pioglitazone HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pioglitazone HCl 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 Pioglitazone HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pioglitazone HCl suppliers with KDMF on PharmaCompass.
A Pioglitazone HCl CEP of the European Pharmacopoeia monograph is often referred to as a Pioglitazone HCl Certificate of Suitability (COS). The purpose of a Pioglitazone HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pioglitazone HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pioglitazone HCl to their clients by showing that a Pioglitazone HCl CEP has been issued for it. The manufacturer submits a Pioglitazone HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pioglitazone HCl CEP holder for the record. Additionally, the data presented in the Pioglitazone HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pioglitazone HCl DMF.
A Pioglitazone HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pioglitazone HCl 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 Pioglitazone HCl suppliers with CEP (COS) on PharmaCompass.
A Pioglitazone HCl written confirmation (Pioglitazone HCl WC) is an official document issued by a regulatory agency to a Pioglitazone HCl manufacturer, verifying that the manufacturing facility of a Pioglitazone HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pioglitazone HCl APIs or Pioglitazone HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Pioglitazone HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Pioglitazone HCl suppliers with Written Confirmation (WC) 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 Pioglitazone HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pioglitazone HCl 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 Pioglitazone HCl 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 Pioglitazone HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pioglitazone HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pioglitazone HCl suppliers with NDC on PharmaCompass.
Pioglitazone HCl 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 Pioglitazone HCl 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 Pioglitazone HCl GMP manufacturer or Pioglitazone HCl GMP API supplier for your needs.
A Pioglitazone HCl CoA (Certificate of Analysis) is a formal document that attests to Pioglitazone HCl's compliance with Pioglitazone HCl specifications and serves as a tool for batch-level quality control.
Pioglitazone HCl CoA mostly includes findings from lab analyses of a specific batch. For each Pioglitazone HCl 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.
Pioglitazone HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Pioglitazone HCl EP), Pioglitazone HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pioglitazone HCl USP).
