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    Chemistry

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    Also known as: 112529-15-4, Pioglitazone hcl, Actos, Piomed, 5-(4-(2-(5-ethylpyridin-2-yl)ethoxy)benzyl)thiazolidine-2,4-dione hydrochloride, U-72107a
    Molecular Formula
    C19H21ClN2O3S
    Molecular Weight
    392.9  g/mol
    InChI Key
    GHUUBYQTCDQWRA-UHFFFAOYSA-N
    FDA UNII
    JQT35NPK6C
    Pioglitazone Hydrochloride
    A thiazolidinedione and PPAR GAMMA agonist that is used in the treatment of TYPE 2 DIABETES MELLITUS.
    1 2D Structure

    Pioglitazone Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-[[4-[2-(5-ethylpyridin-2-yl)ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione;hydrochloride
    2.1.2 InChI
    InChI=1S/C19H20N2O3S.ClH/c1-2-13-3-6-15(20-12-13)9-10-24-16-7-4-14(5-8-16)11-17-18(22)21-19(23)25-17;/h3-8,12,17H,2,9-11H2,1H3,(H,21,22,23);1H
    2.1.3 InChI Key
    GHUUBYQTCDQWRA-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    JQT35NPK6C
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    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

    2.3.2 Depositor-Supplied Synonyms

    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, (+/-)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 392.9 g/mol
    Molecular Formula C19H21ClN2O3S
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count7
    Exact Mass392.0961414 g/mol
    Monoisotopic Mass392.0961414 g/mol
    Topological Polar Surface Area93.6 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity466
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NamePioglitazone hydrochloride
    Drug LabelACTOS (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 IngredientPioglitazone hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 15mg base; eq 30mg base; eq 45mg base
    Market StatusPrescription
    CompanySynthon 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 NamePioglitazone hydrochloride
    Drug LabelACTOS (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 IngredientPioglitazone hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 15mg base; eq 30mg base; eq 45mg base
    Market StatusPrescription
    CompanySynthon Pharms; Mylan Pharms; Accord Hlthcare; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Sandoz; Watson Labs; Macleods Pharms; Zydus Pharms Usa; Dr Reddys Labs

    4.2 Drug Indication

    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).

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Hypoglycemic Agents

    Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    PPAR gamma [CS]; Peroxisome Proliferator Receptor alpha Agonist [EPC]; Peroxisome Proliferator Receptor gamma Agonist [EPC]; Peroxisome Proliferator-activated Receptor Activity [MoA]; Thiazolidinedione [EPC]; Thiazolidinediones [CS]; PPAR alpha [CS]
    5.3 ATC Code

    A10BG03

    A10BG03

    A10BG03

    A10BG03

    A10BG03

    A10BG03

    A10BG03

    A10BG03

    A10BG03

    A10BG03

    API SUPPLIERS

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    Temad Co

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    03

    Dr. Reddy's Laboratories

    India

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

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    CPhI Korea
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-14

    Pay. Date : 2013-12-31

    DMF Number : 21295

    Submission : 2008-01-31

    Status : Active

    Type : II

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    Registration Number : 303MF10161

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2021-10-27

    Latest Date of Registration :

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    Date of Issue : 2022-06-07

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm :

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    NDC Package Code : 55111-052

    Start Marketing Date : 2012-06-22

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Pami Future Co., Ltd.

    Registration Date : 2022-05-17

    Registration Number : 20220517-196-I-633-16

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO-VI, APIIC Industrial Estate, Pydhibeemavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh - 532 409, India

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    04

    Jai Radhe Sales

    India

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    Specialty & Agro Chemical
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    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    05

    Tenatra Chemie

    India

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    Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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    06

    TAPI Technology & API Services

    Israel

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    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16688

    Submission : 2003-07-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2025-04-24

    Valid Till : 2028-05-25

    Written Confirmation Number : WC-0002

    Address of the Firm :

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    NDC Package Code : 15894-0017

    Start Marketing Date : 2023-03-15

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Available Reg Filing : CA, ASMF
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    07

    Dr. Reddy's Laboratories

    India

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

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    Date of Issue : 2022-06-07

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    08

    Zhejiang Huahai Pharmaceutical

    China

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

    Specialty & Agro Chemical
    Not Confirmed
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    Zhejiang Huahai Pharmaceutical

    China

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

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    Specialty & Agro Chemical
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-02-21

    Pay. Date : 2013-09-27

    DMF Number : 27504

    Submission : 2013-09-19

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2013-143 - Rev 01

    Issue Date : 2020-03-06

    Type : Chemical

    Substance Number : 2601

    Status : Valid

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    09

    Zhejiang Huayi Pharmaceutical Co.,...

    China

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    Specialty & Agro Chemical
    Not Confirmed
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    Zhejiang Huayi Pharmaceutical Co.,...

    China

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

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    Specialty & Agro Chemical
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19558

    Submission : 2006-06-28

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2013-096 - Rev 00

    Issue Date : 2014-11-19

    Type : Chemical

    Substance Number : 2601

    Status : Expired

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    10

    Aarti Drugs

    India

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    Specialty & Agro Chemical
    Not Confirmed
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    Aarti Drugs

    India

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    Specialty & Agro Chemical
    Not Confirmed
    USDMF Inactive-api
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26192

    Submission : 2012-07-03

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2022-08-08

    Valid Till : 2025-08-09

    Written Confirmation Number : WC-0253

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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1641839400,"product":"PIOGLITAZONE HCL USP","address":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta","city":"HYDERABAD","supplier":"HETERO LABS LTD","supplierCountry":"INDIA","foreign_port":"MEXICO CITY","customer":"AMAROX PHARMASA DE CV","customerCountry":"MEXICO","quantity":"9.00","actualQuantity":"9","unit":"KGS","unitRateFc":"120","totalValueFC":"187.9","currency":"USD","unitRateINR":1555.5555555555557,"date":"11-Jan-2022","totalValueINR":"14000","totalValueInUsd":"187.9","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"7392195","productDescription":"API","marketType":"","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta, HYDERABAD","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645036200,"product":"PIOGLITAZONE HYDROCHLORIDE USP","address":"KASHIMIRA, W.E.HIGHWAY, NEXT TO DODIA PETROL PUMP,","city":"THANE ,MAHARASHTRA","supplier":"JAYCO CHEMICAL INDUSTRIES","supplierCountry":"INDIA","foreign_port":"BUCHAREST","customer":"UNDISCLOSED","customerCountry":"ROMANIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"120","totalValueFC":"1654.3","currency":"USD","unitRateINR":8266.6666666666661,"date":"17-Feb-2022","totalValueINR":"124000","totalValueInUsd":"1654.3","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8298286","productDescription":"API","marketType":"","country":"ROMANIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"KASHIMIRA, W.E.HIGHWAY, NEXT TO DODIA PETROL PUMP,, THANE ,MAHARASHTRA","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1646937000,"product":"PIOGLITAZONE HCL (TAX INVOICE NO:4900215","address":"MSN HOUSE, PLOT NO.C-24,,INDUSTRIA L ESTATE, SANATHNAGAR","city":"HYDERABAD,TELANGANA","supplier":"MSN ORGANICS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"AIRPHARM PRATTELN","customerCountry":"SWITZERLAND","quantity":"72.00","actualQuantity":"72","unit":"KGS","unitRateFc":"346.5","totalValueFC":"23983.4","currency":"USD","unitRateINR":25388.888888888891,"date":"11-Mar-2022","totalValueINR":"1828000","totalValueInUsd":"23983.4","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"8873082","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE, PLOT NO.C-24,,INDUSTRIA L ESTATE, SANATHNAGAR, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648233000,"product":"PIOGLITAZONE HYDROCHLORIDE","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE, ROAD NO.3, BANJARA HILLS, Contact N","city":"HYDERABAD","supplier":"DR REDDY'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"BERLIN PHARMACEUTICAL INDUSTRY CO","customerCountry":"THAILAND","quantity":"452.10","actualQuantity":"452.1","unit":"KGS","unitRateFc":"210","totalValueFC":"92653.4","currency":"USD","unitRateINR":15620.43795620438,"date":"26-Mar-2022","totalValueINR":"7062000","totalValueInUsd":"92653.4","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"9230228","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE, ROAD NO.3, BANJARA HILLS, Contact N, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648233000,"product":"PIOGLITAZONE HCL USP (GST TAX INVOICE N","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"HETERO DRUGS LTD","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"ON CALL TRADING LLC","customerCountry":"UNITED ARAB EMIRATES","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"95","totalValueFC":"20532.8","currency":"EURO","unitRateINR":7825,"date":"26-Mar-2022","totalValueINR":"1565000","totalValueInUsd":"20532.8","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"9230983","productDescription":"API","marketType":"","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648578600,"product":"PIOGLITAZONE HCL USP EXTRA PURE (MICRO),","address":"ARVIND VITHAL GANDHI CHOWK, B.S.D.MARG, GOVANDI STATION ROAD Co","city":"MUMBAI","supplier":"USV PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"UNITED PHARMACEUTICAL","customerCountry":"JORDAN","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1000","totalValueFC":"14641.9","currency":"USD","unitRateINR":74400,"date":"30-Mar-2022","totalValueINR":"1116000","totalValueInUsd":"14641.9","indian_port":"BOMBAY AIR","hs_no":"29341000","bill_no":"9351317","productDescription":"API","marketType":"","country":"JORDAN","selfForZScoreResived":"Micronized","supplierPort":"BOMBAY AIR","supplierAddress":"ARVIND VITHAL GANDHI CHOWK, B.S.D.MARG, GOVANDI STATION ROAD Co, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649269800,"product":"PIOGLITAZONE HYDROCHLORIDE","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"AUROBINDO PHARMA LTD","supplierCountry":"INDIA","foreign_port":"CINCINNATI, OH","customer":"LGM PHARMA LLC","customerCountry":"UNITED STATES","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"900","totalValueFC":"1497.7","currency":"USD","unitRateINR":56500,"date":"07-Apr-2022","totalValueINR":"113000","totalValueInUsd":"1497.7","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"9538102","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET, HYDERABAD","customerAddress":""},{"dataSource":"API 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    11-Jan-2022
    28-May-2025
    KGS
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    DOSAGE - TABLET;ORAL - EQ 15MG BASE

    USFDA APPLICATION NUMBER - 21073

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    ABOUT THIS PAGE

    Looking for 127676-30-6 / Pioglitazone Hydrochloride API manufacturers, exporters & distributors?

    Pioglitazone Hydrochloride manufacturers, exporters & distributors 1

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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.

    API | Excipient name

    Pioglitazone Hydrochloride

    Synonyms

    112529-15-4, Pioglitazone hcl, Actos, Piomed, 5-(4-(2-(5-ethylpyridin-2-yl)ethoxy)benzyl)thiazolidine-2,4-dione hydrochloride, U-72107a

    Cas Number

    127676-30-6

    Unique Ingredient Identifier (UNII)

    JQT35NPK6C

    About Pioglitazone Hydrochloride

    A thiazolidinedione and PPAR GAMMA agonist that is used in the treatment of TYPE 2 DIABETES MELLITUS.

    AM20061770 Manufacturers

    A AM20061770 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AM20061770, including repackagers and relabelers. The FDA regulates AM20061770 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AM20061770 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 AM20061770 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    AM20061770 Suppliers

    A AM20061770 supplier is an individual or a company that provides AM20061770 active pharmaceutical ingredient (API) or AM20061770 finished formulations upon request. The AM20061770 suppliers may include AM20061770 API manufacturers, exporters, distributors and traders.

    click here to find a list of AM20061770 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    AM20061770 USDMF

    A AM20061770 DMF (Drug Master File) is a document detailing the whole manufacturing process of AM20061770 active pharmaceutical ingredient (API) in detail. Different forms of AM20061770 DMFs exist exist since differing nations have different regulations, such as AM20061770 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A AM20061770 DMF submitted to regulatory agencies in the US is known as a USDMF. AM20061770 USDMF includes data on AM20061770's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AM20061770 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of AM20061770 suppliers with USDMF on PharmaCompass.

    AM20061770 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 AM20061770 Drug Master File in Japan (AM20061770 JDMF) empowers AM20061770 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 AM20061770 JDMF during the approval evaluation for pharmaceutical products. At the time of AM20061770 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 AM20061770 suppliers with JDMF on PharmaCompass.

    AM20061770 KDMF

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

    Pharmaceutical companies submit a AM20061770 Drug Master File in Korea (AM20061770 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AM20061770. The MFDS reviews the AM20061770 KDMF as part of the drug registration process and uses the information provided in the AM20061770 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a AM20061770 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 AM20061770 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of AM20061770 suppliers with KDMF on PharmaCompass.

    AM20061770 CEP

    A AM20061770 CEP of the European Pharmacopoeia monograph is often referred to as a AM20061770 Certificate of Suitability (COS). The purpose of a AM20061770 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AM20061770 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AM20061770 to their clients by showing that a AM20061770 CEP has been issued for it. The manufacturer submits a AM20061770 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AM20061770 CEP holder for the record. Additionally, the data presented in the AM20061770 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AM20061770 DMF.

    A AM20061770 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AM20061770 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 AM20061770 suppliers with CEP (COS) on PharmaCompass.

    AM20061770 WC

    A AM20061770 written confirmation (AM20061770 WC) is an official document issued by a regulatory agency to a AM20061770 manufacturer, verifying that the manufacturing facility of a AM20061770 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AM20061770 APIs or AM20061770 finished pharmaceutical products to another nation, regulatory agencies frequently require a AM20061770 WC (written confirmation) as part of the regulatory process.

    click here to find a list of AM20061770 suppliers with Written Confirmation (WC) on PharmaCompass.

    AM20061770 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 AM20061770 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for AM20061770 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 AM20061770 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 AM20061770 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AM20061770 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of AM20061770 suppliers with NDC on PharmaCompass.

    AM20061770 GMP

    AM20061770 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 AM20061770 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 AM20061770 GMP manufacturer or AM20061770 GMP API supplier for your needs.

    AM20061770 CoA

    A AM20061770 CoA (Certificate of Analysis) is a formal document that attests to AM20061770's compliance with AM20061770 specifications and serves as a tool for batch-level quality control.

    AM20061770 CoA mostly includes findings from lab analyses of a specific batch. For each AM20061770 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.

    AM20061770 may be tested according to a variety of international standards, such as European Pharmacopoeia (AM20061770 EP), AM20061770 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AM20061770 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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