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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

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    LGM Pharma

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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

    arrow
    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
    • EDQM
    • WHO-GMP

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

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    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

     CEP/COS JDMF arrow-down
    ✖

    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 : --

     EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 55111-052

    Start Marketing Date : 2012-06-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
    ✖

    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

     VMF Others AUDIT
    Dr Reddy Company Banner

    Portfolio PDF

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    Corporate PDF

    04

    Jai Radhe Sales

    India

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Jai Radhe Sales

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    USV Private Limited

    India

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16684

    Submission : 2003-07-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-27

    Valid Till : 2025-06-02

    Written Confirmation Number : WC-0012

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62147-0005

    Start Marketing Date : 2010-02-04

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
    ✖

    Registrant Name : Shinpo Farm Co., Ltd.

    Registration Date : 2014-01-08

    Registration Number : 20140108-196-I-396-12

    Manufacturer Name : USV Limited

    Manufacturer Address : B-1/8, MIDC, Lote Parshuram, Industrial Area, Taluka Khed Ratnagiri 415722, Maharashtra State, India.

     VMF Others AUDIT
    USV Private Limited

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    06

    TAPI Technology & API Services

    Israel

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

    arrow
    Isranalytica
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

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    Flag Israel
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16688

    Submission : 2003-07-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-06-17

    Valid Till : 2022-05-26

    Written Confirmation Number : WC-0002

    Address of the Firm :

    NDC arrow-down
    ✖

    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

     KDMF VMF CA, ASMF arrow-down
    ✖
    Available Reg Filing : CA, ASMF
    AUDIT
    TAPI Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    07

    USV Private Limited

    India

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19250

    Submission : 2006-03-10

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62147-0005

    Start Marketing Date : 2010-02-04

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
    ✖

    Registrant Name : Shinpo Farm Co., Ltd.

    Registration Date : 2014-01-08

    Registration Number : 20140108-196-I-396-12

    Manufacturer Name : USV Limited

    Manufacturer Address : B-1/8, MIDC, Lote Parshuram, Industrial Area, Taluka Khed Ratnagiri 415722, Maharashtra State, India.

     VMF Others AUDIT
    USV Private Limited

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    08

    Zhejiang Huayi Pharmaceutical Co.,...

    China

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Zhejiang Huayi Pharmaceutical Co.,...

    China

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    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

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    Zhejiang Huahai Pharmaceutical

    China

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Zhejiang Huahai Pharmaceutical

    China

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    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
    ✖

    Certificate Number : R1-CEP 2013-143 - Rev 01

    Issue Date : 2020-03-06

    Type : Chemical

    Substance Number : 2601

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Aarti Drugs

    India

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Aarti Drugs

    India

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    USDMF Inactive-api
    ✖

    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
    ✖

    Date of Issue : 2022-08-08

    Valid Till : 2025-08-09

    Written Confirmation Number : WC-0253

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    Only 10 entries up to this point, click to access all click full view read-more
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    USDMF

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    01

    Dr Reddys Laboratories Ltd

    India
    arrow
    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-01-14

    Pay. Date : 2013-12-31

    DMF Number : 21295

    Submission : 2008-01-31

    Status : Active

    Type : II

    Dr Reddy Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Usv Private Ltd

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19250

    Submission : 2006-03-10

    Status : Active

    Type : II

    USV Private Limited

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Usv Private Ltd

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16684

    Submission : 2003-07-08

    Status : Active

    Type : II

    USV Private Limited

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    Teva Pharmaceutical Industries Ltd

    Israel
    arrow
    Isranalytica
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

    Contact Supplier Contact Supplier
    Flag Israel
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16688

    Submission : 2003-07-08

    Status : Active

    Type : II

    TAPI Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    Biocon Ltd

    India

    USDMF

    arrow
    BIO Partnering at JPM
    Not Confirmed

    05

    Biocon Ltd

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16635

    Submission : 2003-06-11

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    06

    Cipla Ltd

    India

    USDMF

    arrow
    BIO Partnering at JPM
    Not Confirmed

    06

    Cipla Ltd

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16672

    Submission : 2003-06-30

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    07

    BIO Partnering at JPM
    Not Confirmed

    07

    Ind Swift Laboratories Ltd

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18379

    Submission : 2005-05-21

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    08

    BIO Partnering at JPM
    Not Confirmed

    08

    Morepen Laboratories Ltd

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17701

    Submission : 2004-09-23

    Status : Inactive

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    BIO Partnering at JPM
    Not Confirmed

    09

    Sun Pharmaceutical Industries Ltd

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16682

    Submission : 2003-07-03

    Status : Inactive

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Wockhardt Ltd

    India

    USDMF

    arrow
    BIO Partnering at JPM
    Not Confirmed

    10

    Wockhardt Ltd

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16793

    Submission : 2003-08-28

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    CEP/COS

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    APITORIA PHARMA PRIVATE LIMITED Hyd...

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone hydrochloride

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    CEP 2019-342 - Rev 01
    Valid
    Chemical
    2024-01-12
    2601
    blank

    01

    APITORIA PHARMA PRIVATE LIMITED Hyd...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    BIOCON LIMITED Bengaluru IN

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone hydrochloride, Process I

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    R1-CEP 2014-351 - Rev 00
    Valid
    Chemical
    2021-09-23
    2601
    blank

    02

    BIOCON LIMITED Bengaluru IN

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    BIOCON LIMITED Bangalore IN

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone hydrochloride

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    R1-CEP 2012-340 - Rev 00
    Valid
    Chemical
    2018-10-31
    2601
    blank

    03

    BIOCON LIMITED Bangalore IN

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    HETERO LABS LIMITED Hyderabad IN

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone hydrochloride, PI-process

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    CEP 2023-004 - Rev 00
    Valid
    Chemical
    2024-08-30
    2601
    blank

    04

    HETERO LABS LIMITED Hyderabad IN

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    HETERO LABS LIMITED Hyderabad IN

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone hydrochloride

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    R1-CEP 2012-363 - Rev 00
    Withdrawn by Holder
    Chemical
    2019-07-17
    2019-07-30
    2601
    blank

    05

    HETERO LABS LIMITED Hyderabad IN

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    HETERO LABS LIMITED Hyderabad IN

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone Hydrochloride

    Certificate Number : R1-CEP 2012-363 - Rev 00

    Status : Withdrawn by Holder

    Issue Date : 2019-07-17

    Type : Chemical

    Substance Number : 2601

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    HETERO LABS LIMITED Hyderabad IN

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone hydrochloride, Process II

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    R0-CEP 2017-013 - Rev 01
    Withdrawn by Holder
    Chemical
    2019-04-05
    2019-07-30
    2601
    blank

    06

    HETERO LABS LIMITED Hyderabad IN

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    HETERO LABS LIMITED Hyderabad IN

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone Hydrochloride, Process II

    Certificate Number : R0-CEP 2017-013 - Rev 01

    Status : Withdrawn by Holder

    Issue Date : 2019-04-05

    Type : Chemical

    Substance Number : 2601

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    MSN ORGANICS PRIVATE LIMITED Bibina...

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pioglitazone hydrochloride

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    R1-CEP 2013-005 - Rev 00
    Valid
    Chemical
    2019-02-20
    2601
    blank

    07

    MSN ORGANICS PRIVATE LIMITED Bibina...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    TIANISH LABORATORIES PRIVATE LIMITE...

    Contact Supplier
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Pioglitazone hydrochloride

      Portfolio PDF

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      Virtual Booth

      Digital Content

      Website

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      CEP 2012-315 - Rev 01
      Valid
      Chemical
      2024-07-11
      2601
      blank

      08

      TIANISH LABORATORIES PRIVATE LIMITE...

      India
      BIO Partnering at JPM
      Not Confirmed
      arrow

      TIANISH LABORATORIES PRIVATE LIMITE...

      India
      arrow
      BIO Partnering at JPM
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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      Flag India
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Pioglitazone Hydrochloride

      Certificate Number : CEP 2012-315 - Rev 01

      Status : Valid

      Issue Date : 2024-07-11

      Type : Chemical

      Substance Number : 2601

      blank

      Portfolio PDF

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      Virtual Booth

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      DR. REDDY'S LABORATORIES LIMITED Hy...

      Contact Supplier
      • fda
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AP.","supplier":"MSN ORGANICS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"DEXA MEDICA","customerCountry":"INDONESIA","quantity":"242.00","actualQuantity":"242","unit":"KGS","unitRateFc":"115","totalValueFC":"26692.3","currency":"USD","unitRateINR":9243.1652892561979,"date":"02-Sep-2024","totalValueINR":"2236846","totalValueInUsd":"26692.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3675912","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO.C-24,, HYDERABAD. AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725993000,"product":"(PHARMACEUTICAL RAW MATERIAL OF PHARMACEUTICAL GRADE) - PIOGLITAZONE HYDROCHLORIDE USP 43 MFR:- ABHILASHA PHARMA PVT. 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NO.37","city":"BOMBAY ,MAHARASHTRA","supplier":"TRICON ENTERPRISES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"TO THE ORDER OF","customerCountry":"TAIWAN","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"94.5","totalValueFC":"14017.8","currency":"USD","unitRateINR":7886.2666666666664,"date":"15-Nov-2024","totalValueINR":"1182940","totalValueInUsd":"14017.8","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5631546","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"KAMALA BHUVAN NO.2, 1ST FLR. NO.37, BOMBAY ,MAHARASHTRA","customerAddress":""}]
      07-Jan-2021
      15-Nov-2024
      KGS
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      DRUG PRODUCT COMPOSITIONS

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      DOSAGE - TABLET;ORAL - EQ 15MG BASE

      USFDA APPLICATION NUMBER - 21073

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      DOSAGE - TABLET;ORAL - EQ 30MG BASE

      USFDA APPLICATION NUMBER - 21073

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      DOSAGE - TABLET;ORAL - EQ 45MG BASE

      USFDA APPLICATION NUMBER - 21073

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      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

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      DOSAGE - TABLET;ORAL - 850MG;EQ 15MG BASE

      USFDA APPLICATION NUMBER - 21842

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      DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE

      USFDA APPLICATION NUMBER - 22024

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      DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE

      USFDA APPLICATION NUMBER - 22024

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      ABOUT THIS PAGE

      Actos Manufacturers

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

      Actos Suppliers

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

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

      Actos USDMF

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

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

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

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

      Actos KDMF

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

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

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

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

      Actos CEP

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

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

      Actos WC

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

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

      Actos 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 Actos as an active pharmaceutical ingredient (API).

      Finished drug products

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

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

      Actos GMP

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

      Actos CoA

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

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

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