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Invokana

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TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG
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TABLET, EXTENDED RELEASE;ORAL - 50MG;500MG

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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

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 Formula	C₂₄H₂₅FO₅S
Molecular Weight	444.5 g/mol
XLogP3	3.2
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	5
Exact Mass	444.14067323 g/mol
Monoisotopic Mass	444.14067323 g/mol
Topological Polar Surface Area	118 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	574
Isotope Atom Count	0
Defined Atom Stereocenter Count	5
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Invokana
PubMed Health	Canagliflozin (By mouth)
Drug Classes	Endocrine-Metabolic Agent, Hypoglycemic
Drug Label	INVOKANA (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 Ingredient	Canagliflozin
Dosage Form	Tablet
Route	Oral
Strength	300mg; 100mg
Market Status	Prescription
Company	Janssen Pharms

2 of 2
Drug Name	Invokana
PubMed Health	Canagliflozin (By mouth)
Drug Classes	Endocrine-Metabolic Agent, Hypoglycemic
Drug Label	INVOKANA (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 Ingredient	Canagliflozin
Dosage Form	Tablet
Route	Oral
Strength	300mg; 100mg
Market Status	Prescription
Company	Janssen 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.

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.

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).

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Digital Content

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

04

Aarti Pharmalabs

India

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

Medlab Asia & Asia Health

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

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

05

Aptra Synthesis

India

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

Medlab Asia & Asia Health

Not Confirmed

Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

Contact Supplier

India

Virtual Booth

Digital Content

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

06

HRV Global Life Sciences

India

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

CPHI Middle east

Attending

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

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

AUDIT

07

USV Private Limited

India

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

Medlab Asia & Asia Health

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

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

Portfolio PDF

08

Porton Pharma Solutions

China

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

Medlab Asia & Asia Health

Not Confirmed

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

Contact Supplier

China

Virtual Booth

Digital Content

USDMF

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

09

Bal Pharma

India

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

CPHI Middle east

Booth #A82

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

Contact Supplier

India

Virtual Booth

Digital Content

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

10

Beijing Huikang Boyuan Chemical Te...

China

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

Medlab Asia & Asia Health

Not Confirmed

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USDMF

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EU WC

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NDC API

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Listed Suppliers

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API Reference Price

[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648578600,"product":"CANAGLIFLOZINE HEMIHYDRATE IH","address":"H.NO.8-3-166\/7\/1, HETERO HOUSE, ERRAGADDA Contact No: 919396743330","city":"HYDERABAD","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"M\/S.ZETA PHARMA FOR PHARMACEUTICAL","customerCountry":"EGYPT","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"1550","totalValueFC":"3765.4","currency":"USD","unitRateINR":114800,"date":"30-Mar-2022","totalValueINR":"287000","totalValueInUsd":"3765.4","indian_port":"HYDERABAD AIR","hs_no":"29420090","bill_no":"9334363","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"H.NO.8-3-166\/7\/1, HETERO HOUSE, ERRAGADDA Contact No: 919396743330, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657823400,"product":"CANAGLIFLOZIN HEMIHYDRATE","address":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL E SANATH NAGAR,HYDERABAD","city":"HYDERABAD TS","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TO THE ORDER OF","customerCountry":"ISRAEL","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"3000","totalValueFC":"2842.2","currency":"USD","unitRateINR":226000,"date":"15-Jul-2022","totalValueINR":"226000","totalValueInUsd":"2842.2","indian_port":"HYDERABAD AIR","hs_no":"29054400","bill_no":"2832627","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","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":"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 ","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":"LESS REGULATED MARKET","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":"Q4","strtotime":1699295400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS - (API) CANAGLIFLOZIN","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","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":"2023","qtr":"Q4","strtotime":1699900200,"product":"CANAGLIFLOZIN HEMIHYDRATE IH","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"LISBOA","customer":"XX.REXXY SXXABOXXTORXXS SXX.","customerCountry":"PORTUGAL","quantity":"49.00","actualQuantity":"49","unit":"KGS","unitRateFc":"2389.7","totalValueFC":"115871.7","currency":"USD","unitRateINR":196913.10204081633,"date":"14-Nov-2023","totalValueINR":"9648742","totalValueInUsd":"115871.7","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29141990","bill_no":"4000735","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 ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703183400,"product":"CANAGLIFLOZIN HEMIHYDRATE (*LUT ARN NO:AD271223002123V DATE: 01\/12\/2023)","address":"","city":"","supplier":"GALLEAN HEALTHCARE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"SARL BEKER LABORATORIES","customerCountry":"ALGERIA","quantity":"61.73","actualQuantity":"61.73","unit":"KGS","unitRateFc":"1500","totalValueFC":"91983.5","currency":"USD","unitRateINR":124040.17495545116,"date":"22-Dec-2023","totalValueINR":"7657000","totalValueInUsd":"91983.5","indian_port":"Bombay Air","hs_no":"29322090","bill_no":"6245222","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711823400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER: F32418005231 DT.26.03.2024 CANAGLIFLOZIN HEMIHYDRATE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"TO THE ORDER.,","customerCountry":"ALGERIA","quantity":"102.22","actualQuantity":"102.22","unit":"KGS","unitRateFc":"1500","totalValueFC":"151877.8","currency":"USD","unitRateINR":123374.02171786343,"date":"31-Mar-2024","totalValueINR":"12611292.5","totalValueInUsd":"151877.8","indian_port":"Bombay Air","hs_no":"29322090","bill_no":"8785515","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712255400,"product":"ACTIVE PHARMACEUTICAL INGREDIENTS (API)EXPORT INV NUMBER: GALLEAN GH-16-24-25 DT.01.04.2024 CANAGLIFLOZIN HEMIHYDRATE","address":"","city":"","supplier":"GALLEAN HEALTHCARE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"TO THE ORDER","customerCountry":"ALGERIA","quantity":"96.30","actualQuantity":"96.3","unit":"KGS","unitRateFc":"1500","totalValueFC":"142359.4","currency":"USD","unitRateINR":123448.03738317758,"date":"05-Apr-2024","totalValueINR":"11888046","totalValueInUsd":"142359.4","indian_port":"Bombay Air","hs_no":"29322090","bill_no":"8917170","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"","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 PHARMACEUTICALS","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":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728412200,"product":"CANAGLIFLOZIN HEMIHYDRATE (CG)","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"LONDON METROPOLITAN","customer":"WESSEX FINE CHEMICALS ","customerCountry":"UNITED KINGDOM","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"8000","totalValueFC":"2370.3","currency":"USD","unitRateINR":663884.43333333335,"date":"09-Oct-2024","totalValueINR":"199165.33","totalValueInUsd":"2370.3","indian_port":"Hyderabad Air","hs_no":"29054400","bill_no":"4700548","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"CANAGLIFLOZIN","year":"2021","qtr":"Q2","strtotime":1617561000,"product":"(N.C.V) CANAGLIFLOZIN (FOR TESTING PURPOSE ONLY)","address":"30 FORJETT STREETPOST BOX NO 9301","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.11","actualQuantity":"108.85","unit":"GMS","unitRateFc":"1.8","totalValueFC":"225.4","currency":"EUR","unitRateINR":"154.2","date":"05-Apr-2021","totalValueINR":"16783.22","totalValueInUsd":"225.4","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3441316","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"","customerAddress":"30 FORJETT STREETPOST BOX NO 9301"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643826600,"product":"(N.C.V)CANAGLIFLOZIN (FOR TESTING PURPOSE ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.13","actualQuantity":"132.35","unit":"GMS","unitRateFc":"1.8","totalValueFC":"278.1","currency":"EUR","unitRateINR":"157.5","date":"03-Feb-2022","totalValueINR":"20842.23","totalValueInUsd":"278.1","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"7336844","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":"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":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.08","actualQuantity":"83.19","unit":"GMS","unitRateFc":"1.9","totalValueFC":"165.1","currency":"EUR","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":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.56","actualQuantity":"560.84","unit":"GMS","unitRateFc":"1.8","totalValueFC":"1074.3","currency":"EUR","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"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

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FDA Orange Book

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Europe

01

Janssen-Cilag International NV

Italy

Medlab Asia & Asia Health

Not Confirmed

Not Confirmed

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Canada

01

JANSSEN INC

U.S.A

U.S.A

Medlab Asia & Asia Health

Not Confirmed

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Listed Dossiers

01

Dr. Reddy's Laboratories

India

Medlab Asia & Asia Health

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Canagliflozin; Metformin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 150MG; 1G

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

02

Dr. Reddy's Laboratories

India

Medlab Asia & Asia Health

Not Confirmed

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

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India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Canagliflozin; Metformin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 150MG; 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

03

Dr. Reddy's Laboratories

India

Medlab Asia & Asia Health

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Canagliflozin; Metformin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 50MG; 1G

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

04

Dr. Reddy's Laboratories

India

Medlab Asia & Asia Health

Not Confirmed

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

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India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Canagliflozin; Metformin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 50MG; 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

05

National Pharma

India

Medlab Asia & Asia Health

Not Confirmed

06

TECNIMEDE

Portugal

Portugal

Medlab Asia & Asia Health

Not Confirmed

Only 10 entries up to this point, click to access all

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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

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

USFDA APPLICATION NUMBER - 205879

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

USFDA APPLICATION NUMBER - 205879

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

USFDA APPLICATION NUMBER - 205879

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Coating Systems & Additives

Fillers, Diluents & Binders

Controlled & Modified Release

Direct Compression

Disintegrants & Superdisintegrants

Thickeners and Stabilizers

Lubricants & Glidants

Granulation

Co-Processed Excipients

Topical

Film Formers & Plasticizers

Empty Capsules

Coloring Agents

Solubilizers

Parenteral

Vegetarian Capsules

API Stability Enhancers

Taste Masking

Chewable & Orodispersible Aids

Rheology Modifiers

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US Medicaid Prescriptions

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Patents & EXCLUSIVITIES

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

60 API Suppliers

27 USDMF

8 EU WC

14 NDC API

41 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

8 Drugs in Development

INTERMEDIATES

39 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

55 FDF Dossiers

15 FDA Orange Book

20 Europe

6 Canada

14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM

TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG

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

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

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EXCIPIENTS BY APPLICATIONS

49 Coating Systems & Additives

30 Fillers, Diluents & Binders

28 Controlled & Modified Release

17 Direct Compression

16 Disintegrants & Superdisintegrants

15 Thickeners and Stabilizers

13 Lubricants & Glidants

11 Granulation

9 Co-Processed Excipients

9 Topical

8 Film Formers & Plasticizers

5 Empty Capsules

5 Coloring Agents

5 Solubilizers

4 Parenteral

4 Vegetarian Capsules

4 API Stability Enhancers