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    Chemistry

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    Also known as: 842133-18-0, Canagliflozin anhydrous, Ta-7284, Jnj-28431754, Jnj 24831754zae, Canagliflozin hemihydrate
    Molecular Formula
    C24H25FO5S
    Molecular Weight
    444.5  g/mol
    InChI Key
    XTNGUQKDFGDXSJ-ZXGKGEBGSA-N
    FDA UNII
    6S49DGR869
    Canagliflozin
    A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES.
    Canagliflozin anhydrous is a Sodium-Glucose Cotransporter 2 Inhibitor. The mechanism of action of canagliflozin anhydrous is as a Sodium-Glucose Transporter 2 Inhibitor, and P-Glycoprotein Inhibitor.
    1 2D Structure

    Canagliflozin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S,3R,4R,5S,6R)-2-[3-[[5-(4-fluorophenyl)thiophen-2-yl]methyl]-4-methylphenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
    2.1.2 InChI
    InChI=1S/C24H25FO5S/c1-13-2-3-15(24-23(29)22(28)21(27)19(12-26)30-24)10-16(13)11-18-8-9-20(31-18)14-4-6-17(25)7-5-14/h2-10,19,21-24,26-29H,11-12H2,1H3/t19-,21-,22+,23-,24+/m1/s1
    2.1.3 InChI Key
    XTNGUQKDFGDXSJ-ZXGKGEBGSA-N
    2.1.4 Canonical SMILES
    CC1=C(C=C(C=C1)C2C(C(C(C(O2)CO)O)O)O)CC3=CC=C(S3)C4=CC=C(C=C4)F
    2.1.5 Isomeric SMILES
    CC1=C(C=C(C=C1)[C@H]2[C@@H]([C@H]([C@@H]([C@H](O2)CO)O)O)O)CC3=CC=C(S3)C4=CC=C(C=C4)F
    2.2 Other Identifiers
    2.2.1 UNII
    6S49DGR869
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-(glucopyranosyl)-4-methyl-3-(5-(4-fluorophenyl)-2-thienylmethyl)benzene - T777973

    2. Canagliflozin Hemihydrate

    3. Canagliflozin, Anhydrous

    4. Invokana

    2.3.2 Depositor-Supplied Synonyms

    1. 842133-18-0

    2. Canagliflozin Anhydrous

    3. Ta-7284

    4. Jnj-28431754

    5. Jnj 24831754zae

    6. Canagliflozin Hemihydrate

    7. Canagliflozin [inn]

    8. Canagliflozin Hydrate

    9. (2s,3r,4r,5s,6r)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol

    10. Ta 7284

    11. 1-(glucopyranosyl)-4-methyl-3-(5-(4-fluorophenyl)-2-thienylmethyl)benzene

    12. Jnj 28431754

    13. Chebi:73274

    14. 6s49dgr869

    15. (2s,3r,4r,5s,6r)-2-[3-[[5-(4-fluorophenyl)thiophen-2-yl]methyl]-4-methylphenyl]-6-(hydroxymethyl)oxane-3,4,5-triol

    16. (1s)-1,5-anhydro-1-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4-methylphenyl)-d-glucitol

    17. (1s)-1,5-anhydro-1-(3-{[5-(4-fluorophenyl)-2-thienyl]methyl}-4-methylphenyl)-d-glucitol

    18. (1s)-1,5-anhydro-1-c-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-d-glucitol

    19. D-glucitol,1,5-anhydro-1-c-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-, (1s)-

    20. (1s)-1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4-methylphenyl)-d-glucitol

    21. Unii-6s49dgr869

    22. Jnj 24831754aaa

    23. (2s,3r,4r,5s,6r)-2-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-6-(hydroxymethyl)oxane-3,4,5-triol

    24. Jnj 24831754

    25. Canagliflozin [mi]

    26. Mls006011126

    27. Schembl157162

    28. Canagliflozin [who-dd]

    29. Gtpl4582

    30. Chembl2048484

    31. Hsdb 8284

    32. Amy3291

    33. Bcpp000303

    34. Dtxsid601004469

    35. Jnj 28431754aaa

    36. Bdbm50386885

    37. Mfcd18251436

    38. S2760

    39. Zinc43207238

    40. Akos025401827

    41. Bcp9000477

    42. Ccg-229581

    43. Cs-0522

    44. Db08907

    45. Ks-1443

    46. Ncgc00346691-02

    47. (1s)-1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-d-glucitol

    48. Ac-26303

    49. Hy-10451

    50. Smr004702906

    51. Sw219119-1

    52. A25050

    53. J-500391

    54. Q5030940

    55. (1s)-1,5-anhydro-1-(3-{[5-(4-fluorophenyl)-2-thienyl]methyl}-4-methyl-phenyl)-d-glucitol

    56. (1s)-1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-d- Glucitol

    57. D-glucitol, 1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4- Methylphenyl)-, (1s)-

    58. D-glucitol, 1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4- Methylphenyl)-, (1s)-

    59. D-glucitol, 1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4-methylphenyl)-

    60. Jnj24831754zae; Ta 7284;(2s,3r,4r,5s,6r)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol

    2.4 Create Date
    2008-06-23
    3 Chemical and Physical Properties
    Molecular Weight 444.5 g/mol
    Molecular Formula C24H25FO5S
    XLogP33.2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count5
    Exact Mass444.14067323 g/mol
    Monoisotopic Mass444.14067323 g/mol
    Topological Polar Surface Area118 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity574
    Isotope Atom Count0
    Defined Atom Stereocenter Count5
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameInvokana
    PubMed HealthCanagliflozin (By mouth)
    Drug ClassesEndocrine-Metabolic Agent, Hypoglycemic
    Drug LabelINVOKANA (canagliflozin) contains canagliflozin, an inhibitor of sodium-glucose co-transporter 2 (SGLT2), the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is...
    Active IngredientCanagliflozin
    Dosage FormTablet
    RouteOral
    Strength300mg; 100mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 2  
    Drug NameInvokana
    PubMed HealthCanagliflozin (By mouth)
    Drug ClassesEndocrine-Metabolic Agent, Hypoglycemic
    Drug LabelINVOKANA (canagliflozin) contains canagliflozin, an inhibitor of sodium-glucose co-transporter 2 (SGLT2), the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is...
    Active IngredientCanagliflozin
    Dosage FormTablet
    RouteOral
    Strength300mg; 100mg
    Market StatusPrescription
    CompanyJanssen Pharms

    4.2 Therapeutic Uses

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Canagliflozin is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of September 30, 2015: https://clinicaltrials.gov/search/intervention=Canagliflozin

    Invokana (canagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Invokana (Canagliflozin) Tablet, Film Coated (Updated: September 2015). Available from, as of November 20, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3

    EXPL THER The proximal tubule's sodium-glucose linked transporter-2 (SGLT2) accounts for the vast majority of glucose reabsorption by the kidney. Its selective inhibition, accordingly, leads to substantial glycosuria, lowering blood glucose, and facilitating weight loss in individuals with diabetes. During the past year, two SGLT2 inhibitors, canagliflozin and dapagliflozin, have been approved for the treatment of type 2 diabetes. Beyond their anti-hyperglycemic properties, however, this new class of drugs has several other attributes that provide a theoretical basis for kidney protection. Like agents that block the renin-angiotensin system, SGLT2 inhibitors also reduce single-nephron glomerular filtration rate (SNGFR) in the chronically diseased kidney, though by quite different mechanisms. Additional potentially beneficial effects of SGLT2 inhibition include modest reductions in blood pressure and plasma uric acid. Finally, cell culture studies indicate that glucose uptake from the tubular lumen, as well as from the basolateral compartment, can contribute to proximal tubular production of extracellular matrix proteins. Whether such attributes will translate into reducing the progression of chronic kidney disease will require the undertaking of long-term, dedicated studies.

    PMID:24257692 Gilbert RE; Kidney Int 86(4): 693-700 (2014).

    EXPL THER Management of hypertension in diabetes is critical for reduction of cardiovascular mortality and morbidity. While blood pressure (BP) control has improved over the past two decades, the control rate is still well below 50% in the general population of patients with type 2 diabetes mellitus (T2DM). A new class of oral glucose-lowering agents has recently been approved; the sodium-glucose co-transporter 2 (SGLT2) inhibitors, which act by eliminating large amounts of glucose in the urine. Two agents, dapagliflozin and canagliflozin, are currently approved in the United States and Europe, and empagliflozin and ipragliflozin have reported Phase 3 trials. In addition to glucose lowering, SGLT2 inhibitors are associated with weight loss and act as osmotic diuretics, resulting in a lowering of BP. While not approved for BP-lowering, they may potentially aid BP goal achievement in people within 7-10 mm Hg of goal.

    PMID:24631482 Oliva RV et al; J Am Soc Hypertens 8(5): 330-9.

    4.3 Drug Warning

    Hypersensitivity reactions (e.g., generalized urticaria), some serious, have been reported with canagliflozin treatment. These reactions generally occurred within hours to days of canagliflozin initiation. If a hypersensitivity reaction occurs, the drug should be discontinued, appropriate treatment instituted, and the patient monitored until signs and symptoms resolve.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 3163

    Dose-dependent increases in low-density lipoprotein (LDL)-cholesterol can occur during canagliflozin therapy. Serum LDL-cholesterol concentrations should be monitored during treatment with canagliflozin and such lipid elevations treated according to the standard of care.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 3162

    When canagliflozin is added to therapy with an insulin secretagogue (e.g., a sulfonylurea) or insulin, the incidence of hypoglycemia is increased compared with sulfonylurea or insulin monotherapy. Therefore, patients receiving canagliflozin may require a reduced dosage of the concomitant insulin secretagogue or insulin to reduce the risk of hypoglycemia.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 3162

    Canagliflozin may increase the risk of genital mycotic infections in males (e.g., balanoposthitis, candidal balanitis) and females (e.g., vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis). In clinical trials, patients with a history of genital mycotic infections and uncircumcised males were more likely to develop such infections. Patients should be monitored for genital mycotic infections and appropriate treatment should be instituted if these infections occur.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 3162

    For more Drug Warnings (Complete) data for Canagliflozin (14 total), please visit the HSDB record page.

    4.4 Drug Indication

    This drug is used in conjunction with diet and exercise to increase glycemic control in adults diagnosed with type 2 diabetes mellitus. Another indication for canagliflozin is the prevention of major cardiovascular events (myocardial infarction, stroke, or death due to a cardiovascular cause) in patients with type 2 diabetes, as well as hospitalization for heart failure in patients with type 2 diabetes[L5897,. In addition to the above, canagliflozin can be used to lower the risk of end-stage kidney disease and major increases in serum creatinine and cardiovascular death for patients with a combination of type 2 diabetes mellitus, diabetic nephropathy, and albuminuria. It is important to note that this drug is **not** indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

    FDA Label

    Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

    - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

    - in addition to other medicinal products for the treatment of diabetes.

    For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.

    Treatment of type II diabetes mellitus

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    This drug increases urinary glucose excretion and decreases the renal threshold for glucose (RTG) in a dose-dependent manner. The renal threshold is defined as the lowest level of blood glucose associated with the appearance of detectable glucose in the urine. The end result of canagliflozin administration is increased urinary excretion of glucose and less renal absorption of glucose, decreasing glucose concentration in the blood and improving glycemic control. **A note on type 2 diabetes and cardiovascular disease** The risk of cardiovascular events in diabetes type 2 is increased due to the damaging effects of diabetes on blood vessels and nerves in the cardiovascular system. In particular, there is a tendency for hyperglycemia to create pro-atherogenic (plaque forming) lesions in blood vessels, leading to various fatal and non-fatal events including stroke and myocardial infarction. Long-term glycemic control has been proven to be effective in the prevention of cardiovascular events such as myocardial infarction and stroke in patients with type 2 diabetes.

    5.2 MeSH Pharmacological Classification

    Sodium-Glucose Transporter 2 Inhibitors

    Compounds that inhibit SODIUM-GLUCOSE TRANSPORTER 2. They lower blood sugar by preventing the reabsorption of glucose by the kidney and are used in the treatment of TYPE 2 DIABETES MELLITUS. (See all compounds classified as Sodium-Glucose Transporter 2 Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    CANAGLIFLOZIN ANHYDROUS
    5.3.2 FDA UNII
    6S49DGR869
    5.3.3 Pharmacological Classes
    Sodium-Glucose Cotransporter 2 Inhibitor [EPC]; Sodium-Glucose Transporter 2 Inhibitors [MoA]; P-Glycoprotein Inhibitors [MoA]
    5.4 ATC Code

    A10BK02

    A - Alimentary tract and metabolism

    A10 - Drugs used in diabetes

    A10B - Blood glucose lowering drugs, excl. insulins

    A10BK - Sodium-glucose co-transporter 2 (sglt2) inhibitors

    A10BK02 - Canagliflozin

    5.5 Absorption, Distribution and Excretion

    Absorption

    **Bioavailability and steady-state** The absolute oral bioavailability of canagliflozin, on average, is approximately 65%. Steady-state concentrations are achieved after 4 to 5 days of daily dose administration between the range of 100mg to 300mg. **Effect of food on absorption** Co-administration of a high-fat meal with canagliflozin exerted no appreciable effect on the pharmacokinetic parameters of canagliflozin. This drug may be administered without regard to food. Despite this, because of the potential of canagliflozin to decrease postprandial plasma glucose excretion due to prolonged intestinal glucose absorption, it is advisable to take this drug before the first meal of the day.

    Route of Elimination

    After a single oral radiolabeled dose canagliflozin dose to healthy subjects, the following ratios of canagliflozin or metabolites were measured in the feces and urine: **Feces** 41.5% as the unchanged radiolabeled drug 7.0% as a hydroxylated metabolite 3.2% as an O-glucuronide metabolite **Urine** About 33% of the ingested radiolabled dose was measured in the urine, generally in the form of O-glucuronide metabolites. Less than 1% of the dose was found excreted as unchanged drug in urine.

    Volume of Distribution

    This drug is extensively distributed throughout the body. On average, the volume of distribution of canagliflozin at steady state following a single intravenous dose in healthy patients was measured to be 83.5 L.

    Clearance

    In healthy subjects, canagliflozin clearance was approximately 192 mL/min after intravenous (IV) administration. The renal clearance of 100 mg and 300 mg doses of canagliflozin was measured to be in the range of 1.30 - 1.55 mL/min.

    /MILK/ Canagliflozin is distributed into milk in rats; it is not known whether the drug is distributed into human milk.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 3163

    Canagliflozin is an oral antihyperglycemic agent used for the treatment of type 2 diabetes mellitus. It blocks the reabsorption of glucose in the proximal renal tubule by inhibiting the sodium-glucose cotransporter 2. This article describes the in vivo biotransformation and disposition of canagliflozin after a single oral dose of [(14)C]canagliflozin to intact and bile duct-cannulated (BDC) mice and rats and to intact dogs and humans. Fecal excretion was the primary route of elimination of drug-derived radioactivity in both animals and humans. In BDC mice and rats, most radioactivity was excreted in bile. The extent of radioactivity excreted in urine as a percentage of the administered [(14)C]canagliflozin dose was 1.2%-7.6% in animals and approximately 33% in humans. The primary pathways contributing to the metabolic clearance of canagliflozin were oxidation in animals and direct glucuronidation of canagliflozin in humans. Unchanged canagliflozin was the major component in systemic circulation in all species. In human plasma, two pharmacologically inactive O-glucuronide conjugates of canagliflozin, M5 and M7, represented 19% and 14% of total drug-related exposure and were considered major human metabolites. Plasma concentrations of M5 and M7 in mice and rats from repeated dose safety studies were lower than those in humans given canagliflozin at the maximum recommended dose of 300 mg. However, biliary metabolite profiling in rodents indicated that mouse and rat livers had significant exposure to M5 and M7. Pharmacologic inactivity and high water solubility of M5 and M7 support glucuronidation of canagliflozin as a safe detoxification pathway.

    PMID:24568888 Mamidi RN et al. Drug Metab Dispos 42(5): 903-16 (2014).

    The mean absolute oral bioavailability of canagliflozin is approximately 65%. Co-administration of a high-fat meal with canagliflozin had no effect on the pharmacokinetics of canagliflozin; therefore, INVOKANA may be taken with or without food. However, based on the potential to reduce postprandial plasma glucose excursions due to delayed intestinal glucose absorption, it is recommended that INVOKANA be taken before the first meal of the day. The mean steady-state volume of distribution of canagliflozin following a single intravenous infusion in healthy subjects was 119 L, suggesting extensive tissue distribution. Canagliflozin is extensively bound to proteins in plasma (99%), mainly to albumin. Protein binding is independent of canagliflozin plasma concentrations. Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment. Following administration of a single oral [14C] canagliflozin dose to healthy subjects, 41.5%, 7.0%, and 3.2% of the administered radioactive dose was recovered in feces as canagliflozin, a hydroxylated metabolite, and an O-glucuronide metabolite, respectively. Enterohepatic circulation of canagliflozin was negligible. Approximately 33% of the administered radioactive dose was excreted in urine, mainly as O-glucuronide metabolites (30.5%). Less than 1% of the dose was excreted as unchanged canagliflozin in urine. Renal clearance of canagliflozin 100 mg and 300 mg doses ranged from 1.30 to 1.55 mL/min. Mean systemic clearance of canagliflozin was approximately 192 mL/min in healthy subjects following intravenous administration.

    NIH; DailyMed. Current Medication Information for Invokana (Canagliflozin) Tablet, Film Coated (Updated: September 2015). Available from, as of November 20, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3

    5.6 Metabolism/Metabolites

    Canagliflozin is primarily metabolized by O-glucuronidation. It is mainly glucuronidated by UGT1A9 and UGT2B4 enzymes to two inactive O-glucuronide metabolites. The oxidative metabolism of canagliflozin by hepatic cytochrome enzyme CYP3A4 is negligible (about 7%) in humans.

    O-glucuronidation is the major metabolic elimination pathway for canagliflozin, which is mainly glucuronidated by UGT1A9 and UGT2B4 to two inactive O-glucuronide metabolites. CYP3A4-mediated (oxidative) metabolism of canagliflozin is minimal (approximately 7%) in humans.

    NIH; DailyMed. Current Medication Information for Invokana (Canagliflozin) Tablet, Film Coated (Updated: September 2015). Available from, as of November 20, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3

    5.7 Biological Half-Life

    In a clinical study, the terminal half-life of canagliflozin was 10.6 hours for the 100mg dose and 13.1 hours for the 300 mg dose.

    5.8 Mechanism of Action

    The sodium-glucose co-transporter2 (SGLT2), is found in the proximal tubules of the kidney, and reabsorbs filtered glucose from the renal tubular lumen. Canagliflozin inhibits the SGLT2 co-transporter. This inhibition leads to lower reabsorption of filtered glucose into the body and decreases the renal threshold for glucose (RTG), leading to increased glucose excretion in the urine.

    Sodium-glucose co-transporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Canagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, canagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose (RTG), and thereby increases urinary glucose excretion (UGE).

    NIH; DailyMed. Current Medication Information for Invokana (Canagliflozin) Tablet, Film Coated (Updated: September 2015). Available from, as of November 20, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3

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    Suanfarma

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    02

    LGM Pharma

    U.S.A

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

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    Exhibiting
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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    LGM Pharma CB

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    03

    Metrochem API Private Limited

    India

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

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    CPhI China
    Booth #E1H57
    • fda
    • EDQM
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Metrochem

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    04

    Rochem International Inc

    U.S.A

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

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    CPhI China
    Booth #W2B28
    • fda
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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Rochem

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    05

    Aarti Pharmalabs

    India

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

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    CPhI China
    Booth #E1C26
    • fda
    • EDQM
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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    Aarti Industries Company Banner

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    06

    HRV Global Life Sciences

    India

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

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    Attending
    • fda
    • EDQM
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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Available Reg Filing : AU, ASMF
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    HRV Global Life Sciences

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    07

    Porton Pharma Solutions

    China

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

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    CPhI China
    Booth #E2A32
    • fda
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    Virtual BoothPorton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39703

    Submission : 2024-03-20

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Porton Company Banner

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    08

    Bal Pharma

    India

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

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    IMCAS Asia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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    BalPharma

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    09

    Zhejiang Jingsheng Pharmaceutical

    China

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

    IMCAS Asia
    Not Confirmed
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    Zhejiang Jingsheng Pharmaceutical

    China

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

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    IMCAS Asia
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39627

    Submission : 2024-03-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Beijing Huikang Boyuan Chemical Te...

    China

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

    IMCAS Asia
    Not Confirmed
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    Beijing Huikang Boyuan Chemical Te...

    China

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

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    IMCAS Asia
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29434

    Submission : 2015-06-10

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Listed Suppliers

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    01

    Suanfarma

    Spain
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    CPhI China
    Booth #E1N28
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSuanfarma, at the Core of a Better Life.

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    Canagliflozin

    About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indus...

    Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
    Suanfarma

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    02

    LGM Pharma

    U.S.A
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    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Digital Content Digital Content

    Canagliflozin

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
    LGM Pharma CB

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    03

    Metrochem API Private Limited

    India
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    CPhI China
    Booth #E1H57
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Canagliflozin

    About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
    Metrochem

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    04

    Rochem International Inc

    U.S.A
    arrow
    CPhI China
    Booth #W2B28
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Canagliflozin

    About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

    Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
    Rochem

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    05

    Aarti Pharmalabs

    India
    arrow
    CPhI China
    Booth #E1C26
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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    Canagliflozin

    About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...

    Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
    Aarti Industries Company Banner

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    06

    HRV Global Life Sciences

    India
    arrow
    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Digital Content Digital Content

    Canagliflozin

    About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

    HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
    HRV Global Life Sciences

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    07

    Porton Pharma Solutions

    China
    arrow
    CPhI China
    Booth #E2A32
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothPorton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

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    Canagliflozin

    About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...

    Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities are located in China, Slovenia, the US, Belgium, Switzerland, Denmark, with more than 6000 employees worldwide. Porton leads the way with its excellent CDMO services, but also supplies APIs & intermediates for the treatment of critical diseases such as HIV/AIDS, diabetes, cancer, & influenza. Our Process Technology Centers & WHO/USFDA/EMA/PDMA/NMPA-inspected Facilities feature state-of-the-art equipment, highly flexible cGMP-compliant production assets.
    Porton Company Banner

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    08

    Bal Pharma

    India
    arrow
    IMCAS Asia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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    Canagliflozin

    About the Company : Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk ac...

    Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk actives. We are dedicated to enhancing patients' quality of life by offering products that are safe, effective, high-quality, and affordable. Bal Pharma's APIs and FDFs are produced at world-class manufacturing facilities. Our APIs are widely exported to Europe, the Far East, Latin America, Africa, the Middle East, and other global markets. Our FDFs are exported to semi-regulated and non-regulated markets, and we are now entering regulated markets.
    BalPharma

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    09

    Aspire Lifesciences Pvt Ltd

    India
    IMCAS Asia
    Not Confirmed
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    Aspire Lifesciences Pvt Ltd

    India
    arrow
    IMCAS Asia
    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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    Canagliflozin

    About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

    Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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    10

    Dasami Lab

    India
    IMCAS Asia
    Not Confirmed
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    Dasami Lab

    India
    arrow
    IMCAS Asia
    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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    Digital Content Digital Content

    Canagliflozin

    About the Company : Dasami Lab Private Limited incorporated with MCA on 24 July 2015. The Dasami Lab Private Limited is listed in the class of pvtltd company and classified as Non Govt Company. This c...

    Dasami Lab Private Limited incorporated with MCA on 24 July 2015. The Dasami Lab Private Limited is listed in the class of pvtltd company and classified as Non Govt Company. This company is registered at Registrar of Companies(ROC), Hyderabad with an Authorized Share Capital of Rs. 110 CR and its paid up capital is 110 CR.
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    Only 10 entries up to this point, click to access all click full view read-more
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1648751400,"product":"CANAGLIFLOZIN AMORPHOUS (TAX INV NO:5910","address":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL E SANATH NAGAR,HYDERABAD","city":"HYDERABAD TS","supplier":"MSN LIFE SCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"HO CHI MINH C","customer":"DRP INTER COLTD","customerCountry":"VIETNAM","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"2500","totalValueFC":"1192.9","currency":"USD","unitRateINR":180000,"date":"01-Apr-2022","totalValueINR":"90000","totalValueInUsd":"1192.9","indian_port":"HYDERABAD AIR","hs_no":"29054400","bill_no":"9410177","productDescription":"API","marketType":"","country":"VIETNAM, DEMOCRATIC REP. OF","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL E SANATH NAGAR,HYDERABAD, HYDERABAD TS","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659897000,"product":"CANAGLIFLOZIN HEMIHYDRATE IH","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"CT0-SEZ -PROCESS UNIT1 DRREDDYS LABORATORIES LT","supplierCountry":"INDIA","foreign_port":"LISBOA","customer":"DRREDDY'S LABORATOIES SA","customerCountry":"PORTUGAL","quantity":"84.00","actualQuantity":"84","unit":"KGS","unitRateFc":"2399","totalValueFC":"198056.4","currency":"USD","unitRateINR":187604.54761904763,"date":"08-Aug-2022","totalValueINR":"15758782","totalValueInUsd":"198056.4","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29141990","bill_no":"4000327","productDescription":"API","marketType":"REGULATED MARKET","country":"PORTUGAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Reddy r-SEZ\/Srikakulam","supplierAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690223400,"product":"PHARMA INGREDIENTS - CANAGLIFLOZIN IN-HO","address":"30, AROHI VILLA, S.P. RING ROAD, BOPAL,","city":"AHMEDABAD","supplier":"GREENCROSS EXPORT PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"TO THE ORDER -+-","customerCountry":"RUSSIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"5000","totalValueFC":"14576.1","currency":"USD","unitRateINR":399333.20699999999,"date":"25-Jul-2023","totalValueINR":"1197999.621","totalValueInUsd":"14576.1","indian_port":"AHMEDABAD AIR","hs_no":"29054400","bill_no":"0","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"30, AROHI VILLA, S.P. RING ROAD, BOPAL,, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695234600,"product":"CANAGLIFLOZIN HEMIHYDRATE (CG)","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"MSN LIFE SCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"TO THE ORDER OF","customerCountry":"THAILAND","quantity":"4.50","actualQuantity":"4.5","unit":"KGS","unitRateFc":"1100","totalValueFC":"4842.9","currency":"USD","unitRateINR":89333.333333333328,"date":"21-Sep-2023","totalValueINR":"402000","totalValueInUsd":"4842.9","indian_port":"Hyderabad Air","hs_no":"29054400","bill_no":"4071072","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699295400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS - (API) CANAGLIFLOZIN","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"TO THE ORDER OF","customerCountry":"KOREA, REPUBLIC OF","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"2965","totalValueFC":"17605.2","currency":"USD","unitRateINR":244333.33333333334,"date":"07-Nov-2023","totalValueINR":"1466000","totalValueInUsd":"17605.2","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"5186931","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699295400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS - (API) CANAGLIFLOZIN","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"TO THE ORDER OF","customerCountry":"KOREA, REPUBLIC OF","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"2965","totalValueFC":"17605.2","currency":"USD","unitRateINR":244333.33333333334,"date":"07-Nov-2023","totalValueINR":"1466000","totalValueInUsd":"17605.2","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"5196137","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719426600,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER:F32518001040 DT.21.06.2024 CANAGLIFLOZIN HEMIHYDRATE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK LIFE SCIENCES LIMITED","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"TO THE ORDER","customerCountry":"ALGERIA","quantity":"39.75","actualQuantity":"39.75","unit":"KGS","unitRateFc":"1500","totalValueFC":"58554.6","currency":"USD","unitRateINR":122971.13962264151,"date":"27-Jun-2024","totalValueINR":"4888102.8","totalValueInUsd":"58554.6","indian_port":"Bombay Air","hs_no":"29322090","bill_no":"1986476","productDescription":"API","marketType":"","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"CANAGLIFLOZIN IN-HOUSE","address":"INDOCO HOUSE,166 CST RD.VIDYANAGRI,","city":"MUMBAI.MAHARASHTRA","supplier":"INDOCO REMEDIES LIMITED","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"TO ORDER","customerCountry":"TAIWAN","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"1475","totalValueFC":"2080.1","currency":"USD","unitRateINR":115917.83333333333,"date":"12-Jul-2024","totalValueINR":"173876.75","totalValueInUsd":"2080.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"2387289","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"INDOCO HOUSE,166 CST RD.VIDYANAGRI,, MUMBAI.MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740681000,"product":"CANAGLIFLOZIN HEMIHYDRATE IH","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"CT0-SEZ -PROCESS UNIT1 DRREDDYS LABORATORIES LT","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"XX RXXDY'XXLABXXATOXXES XXA","customerCountry":"GREECE","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"2299.1","totalValueFC":"22748.9","currency":"USD","unitRateINR":197833.5,"date":"28-Feb-2025","totalValueINR":"1978335","totalValueInUsd":"22748.9","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29141990","bill_no":"4000038","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Reddy r-SEZ\/Srikakulam","supplierAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652812200,"product":"(N.C.V) CANAGLIFLOZIN (FOR TESTING PURPOSE ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JANSSEN PHARMACEUTICA NV","supplierCountry":"BELGIUM","foreign_port":"NA","customer":"JOHNSON & JOHNSON PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.08","actualQuantity":"83.19","unit":"GMS","unitRateFc":"1.9","totalValueFC":"165.1","currency":"EURO","unitRateINR":"153.4","date":"18-May-2022","totalValueINR":"12757.49","totalValueInUsd":"165.1","indian_port":"BOMBAY AIR","hs_no":"29332990","bill_no":"8731653","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680546600,"product":"(N.C.V) CANAGLIFLOZIN (FOR TESTING PURPOSE ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JANSSEN PHARMACEUTICA NV","supplierCountry":"BELGIUM","foreign_port":"NA","customer":"JOHNSON & JOHNSON PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.56","actualQuantity":"560.84","unit":"GMS","unitRateFc":"1.8","totalValueFC":"1074.3","currency":"EURO","unitRateINR":"157","date":"04-Apr-2023","totalValueINR":"88045.47","totalValueInUsd":"1074.3","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"5367779","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715365800,"product":"(N.C.V) CANAGLIFLOZIN (FOR TESTING PURPOSE ONLY)","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JANSSEN PHARMACEUTICA NV","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"302.7","unit":"GMS","unitRateFc":"1.7","totalValueFC":"562.1","currency":"EURO","unitRateINR":"154.8","date":"11-May-2024","totalValueINR":"46854.99","totalValueInUsd":"562.1","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"3433038","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , BelgiumSDNF Belgium","customerAddress":"30 FORJETT STREET"}]
    01-Apr-2022
    28-Feb-2025
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    API Imports and Exports

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    INTERMEDIATE SUPPLIERS

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    01

    Virupaksha Organics

    India
    CPhI WW Frankfurt
    Booth #11.0F34
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    Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

    2-(5-Bromo-2-methyl benzyl)-5-(4-fluorophenyl)thio...

    CAS Number : 1030825-20-7

    End Use API : Canagliflozin

    About The Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of les...

    Virupaksha

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    02

    Aarti Pharmalabs

    India
    CPhI China
    Booth #E1C26
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    • EDQM
    • WHO-GMP

    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

    2-(5-Bromo-2-Methyl benzyl)-5-(4-uoro phenyl) thio...

    CAS Number : 1030825-20-7

    End Use API : Canagliflozin

    About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

    Aarti Industries Company Banner

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    03

    Aarti Pharmalabs

    India
    CPhI China
    Booth #E1C26
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    • EDQM
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

    2-(4-Fluorophenyl)-5-(5-iodo methyl phenyl) methyl...

    CAS Number : 898566-17-1

    End Use API : Canagliflozin

    About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

    Aarti Industries Company Banner

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    04

    Aarti Pharmalabs

    India
    CPhI China
    Booth #E1C26
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

    2,3,4,6-Tetrakis-O-trimethylsilyl-D-glucono-1,5-la...

    CAS Number : 32384-65-9

    End Use API : Canagliflozin

    About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

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    05

    AR Life Sciences

    India
    IMCAS Asia
    Not Confirmed
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    AR Life Sciences

    India
    IMCAS Asia
    Not Confirmed
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    2,3,4,6-tetrakis-O-trimethylsilyl-D-glucono-1,5-la...

    CAS Number : 32384-65-9

    End Use API : Canagliflozin

    About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...

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    06

    Aventus Labs

    India
    IMCAS Asia
    Not Confirmed
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    Aventus Labs

    India
    IMCAS Asia
    Not Confirmed
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    2-[(5-Bromo-2-methylphenyl)methyl]-5-(4-fluorophen...

    CAS Number : 1030825-20-7

    End Use API : Canagliflozin

    About The Company : Aventus Labs is a forward-thinking pharmaceutical company committed to developing and delivering high-quality, effective healthcare solutions. With a focus on r...

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    07

    Aventus Labs

    India
    IMCAS Asia
    Not Confirmed
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    Aventus Labs

    India
    IMCAS Asia
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    2-(4-Fluorophenyl)-5-[(5-iodo-2-methylphenyl)methy...

    CAS Number : 898566-17-1

    End Use API : Canagliflozin

    About The Company : Aventus Labs is a forward-thinking pharmaceutical company committed to developing and delivering high-quality, effective healthcare solutions. With a focus on r...

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    08

    Cangzhou Enke Pharma-tech Co., Ltd

    China
    IMCAS Asia
    Not Confirmed
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    Cangzhou Enke Pharma-tech Co., Ltd

    China
    IMCAS Asia
    Not Confirmed
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    2,3,4,6-Tetrakis-O-trimethylsilyl-D-gluconolactone

    CAS Number : 32384-65-9

    End Use API : Canagliflozin

    About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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    09

    Cangzhou Enke Pharma-tech Co., Ltd

    China
    IMCAS Asia
    Not Confirmed
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    Cangzhou Enke Pharma-tech Co., Ltd

    China
    IMCAS Asia
    Not Confirmed
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    Canagliflozin hemihydrate

    CAS Number : 928672-86-0

    End Use API : Canagliflozin

    About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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    10

    Cangzhou Enke Pharma-tech Co., Ltd

    China
    IMCAS Asia
    Not Confirmed
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    Cangzhou Enke Pharma-tech Co., Ltd

    China
    IMCAS Asia
    Not Confirmed
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    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.

    Methyl 1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methy...

    CAS Number : 1030825-21-8

    End Use API : Canagliflozin

    About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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

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    01

    JANSSEN PHARMS

    U.S.A
    Global DDF Summit
    Not Confirmed
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    JANSSEN PHARMS

    U.S.A
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    Flag U.S.A
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    RLD : Yes

    TE Code :

    CANAGLIFLOZIN

    Brand Name : INVOKANA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 300MG

    Approval Date : 2013-03-29

    Application Number : 204042

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    02

    JANSSEN PHARMS

    U.S.A
    Global DDF Summit
    Not Confirmed
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    JANSSEN PHARMS

    U.S.A
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    Global DDF Summit
    Not Confirmed
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    RLD : Yes

    TE Code :

    CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : INVOKAMET

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG;500MG

    Approval Date : 2014-08-08

    Application Number : 204353

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    JANSSEN PHARMS

    U.S.A
    Global DDF Summit
    Not Confirmed
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    JANSSEN PHARMS

    U.S.A
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    Global DDF Summit
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    RLD : Yes

    TE Code :

    CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : INVOKAMET

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG;1GM

    Approval Date : 2014-08-08

    Application Number : 204353

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    JANSSEN PHARMS

    U.S.A
    Global DDF Summit
    Not Confirmed
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    JANSSEN PHARMS

    U.S.A
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    Global DDF Summit
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    RLD : Yes

    TE Code :

    CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : INVOKAMET

    Dosage Form : TABLET;ORAL

    Dosage Strength : 150MG;500MG

    Approval Date : 2014-08-08

    Application Number : 204353

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    05

    JANSSEN PHARMS

    U.S.A
    Global DDF Summit
    Not Confirmed
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    JANSSEN PHARMS

    U.S.A
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    Global DDF Summit
    Not Confirmed
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    Virtual Booth Virtual Booth
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    RLD : Yes

    TE Code :

    CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : INVOKAMET

    Dosage Form : TABLET;ORAL

    Dosage Strength : 150MG;1GM

    Approval Date : 2014-08-08

    Application Number : 204353

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    06

    JANSSEN PHARMS

    U.S.A
    Global DDF Summit
    Not Confirmed
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    JANSSEN PHARMS

    U.S.A
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    Global DDF Summit
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    RLD : Yes

    TE Code :

    CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : INVOKAMET XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 50MG;500MG

    Approval Date : 2016-09-20

    Application Number : 205879

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    07

    JANSSEN PHARMS

    U.S.A
    Global DDF Summit
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    JANSSEN PHARMS

    U.S.A
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    Global DDF Summit
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    RLD : Yes

    TE Code :

    CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    Brand Name : INVOKAMET XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 50MG;1GM

    Approval Date : 2016-09-20

    Application Number : 205879

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    08

    JANSSEN PHARMS

    U.S.A
    Global DDF Summit
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    JANSSEN PHARMS

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    CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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    Dosage Strength : 150MG;500MG

    Approval Date : 2016-09-20

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    RX/OTC/DISCN : RX

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM

    USFDA APPLICATION NUMBER - 205879

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG

    USFDA APPLICATION NUMBER - 205879

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;1GM

    USFDA APPLICATION NUMBER - 205879

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;500MG

    USFDA APPLICATION NUMBER - 205879

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    ABOUT THIS PAGE

    Looking for 842133-18-0 / Canagliflozin API manufacturers, exporters & distributors?

    Canagliflozin manufacturers, exporters & distributors 1

    47

    PharmaCompass offers a list of Canagliflozin 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 Canagliflozin manufacturer or Canagliflozin supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Canagliflozin manufacturer or Canagliflozin supplier.

    PharmaCompass also assists you with knowing the Canagliflozin API Price utilized in the formulation of products. Canagliflozin API Price is not always fixed or binding as the Canagliflozin Price is obtained through a variety of data sources. The Canagliflozin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Canagliflozin

    Synonyms

    842133-18-0, Canagliflozin anhydrous, Ta-7284, Jnj-28431754, Jnj 24831754zae, Canagliflozin hemihydrate

    Cas Number

    842133-18-0

    Unique Ingredient Identifier (UNII)

    6S49DGR869

    About Canagliflozin

    A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES.

    Canagliflozin Hemihydrate Manufacturers

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

    Canagliflozin Hemihydrate Suppliers

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

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

    Canagliflozin Hemihydrate USDMF

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

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

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

    Canagliflozin Hemihydrate KDMF

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

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

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

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

    Canagliflozin Hemihydrate WC

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

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

    Canagliflozin Hemihydrate 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 Canagliflozin Hemihydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Canagliflozin Hemihydrate GMP

    Canagliflozin Hemihydrate 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 Canagliflozin Hemihydrate 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 Canagliflozin Hemihydrate GMP manufacturer or Canagliflozin Hemihydrate GMP API supplier for your needs.

    Canagliflozin Hemihydrate CoA

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

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

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