novugen pharma (usa) llc - Medication Listings

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate or 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg and 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Meets USP Dissolution Test 2. Abiraterone Acetate Structural Formula

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(7-amino-3-oxo-1H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(7-amino-3-oxo-1H-isoindol-2-yl) piperidine-2,6-dione The molecular formula for lenalidomide is C 13 H 13 N 3 O 3, and the gram molecular weight is 259.26. Lenalidomide is white to yellow crystalline powder. It is practically insoluble in isopropanol and ethanol. Very slightly soluble in water. Slightly soluble in acetonitrile and methanol. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and microcrystalline cellulose. The 5 mg and 25 mg capsule shells contain gelatin, titanium dioxide, and black ink. The 2.5 mg and 10 mg capsule shells contain FD&C blue #2, gelatin, titanium dioxide, yellow iron oxide, and black ink. The 15 mg capsule shells contain FD&C blue #2, gelatin, titanium dioxide, and black ink. The 20 mg capsule shells contain FD&C blue #2, gelatin, titanium dioxide, yellow iron oxide, and black ink. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. chemical structure

Name: Midodrine Hydrochloride Tablets, USP Dosage Form: 2.5 mg, 5 mg, and 10 mg tablets for oral administration Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg, and 10 mg Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and sodium lauryl sulfate Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(β-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural formula: Molecular formula: C 12 H 18 N 2 O 4. HCl; Molecular Weight: 290.7 Organoleptic Properties: White, crystalline powder Solubility: Water: Soluble Methanol: Sparingly soluble pKa: 7.8 pH: 4.0 to 5.0 (5% aqueous solution) Melting Range: 200°C to 203°C Meets USP Dissolution Test 2. Midodrine-hydro-tablet-usp-structure

Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium, USP that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4­ enoic acid sodium salt. Its molecular formula is C 17 H 19 O 6 Na. The molecular weight is 342.32 g/mol and the structural formula is: Mycophenolic acid, as the sodium salt, is a white to off-white, crystalline powder and is slightly soluble in water and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, and povidone (K-30). The enteric coating of the tablet consists of ferric oxide yellow, hypromellose phthalate, titanium dioxide, and FD&C blue no. 2 powder (180 mg) or ferric oxide red (360 mg). image description

Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzolsulfonamide hydrochloride. It has the molecular formula C 21 H 23 N 7 O 2 S•HCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure: Pazopanib hydrochloride is a white to off-white powder. It is sparingly soluble in dimethyl sulfoxide, slightly soluble in methanol, practically insoluble in acetonitrile, and in water. Pazopanib tablets are for oral use. Each tablet contains 200 mg of pazopanib free base equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of pazopanib tablets are: Tablet Core : magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: Gray film-coat: hypromellose, iron oxide black, iron oxide yellow, macrogol/polyethylene glycol 400 (PEG 400), polysorbate 80, and titanium dioxide. chemical structure

Sacubitril and valsartan tablets are a combination of sacubitril sodium, a neprilysin inhibitor and valsartan disodium, an angiotensin II receptor blocker. Sacubitril sodium is a white to almost white powder and freely soluble in methanol and water, and practically insoluble in acetone. The chemical name of sacubitril sodium is 4-(((2S,4R)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoic acid sodium. The molecular formula is C 24 H 28 NO 5 ·Na and its molecular weight is 433.48. Its structural formula is: Valsartan disodium is a white to almost white powder and freely soluble in water and anhydrous ethanol, and almost insoluble in dichloromethane. The chemical name of valsartan disodium is L-Valine, N-(1-oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-, sodium salt trihydrate (1:2:3). The molecular formula is C 24 H 33 N 5 Na 2 O 6 and its molecular weight is 533.54. Its structural formula is: Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg of sacubitril sodium and 26 mg of valsartan equivalent to 28.3 mg of valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg of sacubitril sodium and 51 mg of valsartan equivalent to 56.6 mg of valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg of sacubitril sodium and 103 mg of valsartan equivalent to 113.2 mg of valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are glycerol esters of fatty acids, polyvinyl alcohol-part hydrolysed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow. The film-coat for the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black, iron oxide red, and iron oxide yellow. sacubitril sodium valsartan disodium

Sacubitril and valsartan tablets are a combination of sacubitril sodium, a neprilysin inhibitor and valsartan disodium, an angiotensin II receptor blocker. Sacubitril sodium is a white to almost white powder and freely soluble in methanol and water, and practically insoluble in acetone. The chemical name of sacubitril sodium is 4-(((2S,4R)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoic acid sodium. The molecular formula is C 24 H 28 NO 5 ·Na and its molecular weight is 433.48. Its structural formula is: Valsartan disodium is a white to almost white powder and freely soluble in water and anhydrous ethanol, and almost insoluble in dichloromethane. The chemical name of valsartan disodium is L-Valine, N-(1-oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-, sodium salt trihydrate (1:2:3). The molecular formula is C 24 H 33 N 5 Na 2 O 6 and its molecular weight is 533.54. Its structural formula is: Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg of sacubitril sodium and 26 mg of valsartan equivalent to 28.3 mg of valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg of sacubitril sodium and 51 mg of valsartan equivalent to 56.6 mg of valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg of sacubitril sodium and 103 mg of valsartan equivalent to 113.2 mg of valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are glycerol esters of fatty acids, polyvinyl alcohol-part hydrolysed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow. sacubitril sodium valsartan disodium

Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-(2-(Diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide (2S)-hydroxybutanedioate acid. The molecular formula is C 22 H 27 FN 4 O 2 • C 4 H 6 O 5 and the molecular weight is 532.6 g/mol. The chemical structure of sunitinib malate is: Sunitinib malate is a yellow or orange-yellow powder with a pKa of 8.95. The solubility of sunitinib malate is slightly soluble in water, practically insoluble in ethanol. Sunitinib malate capsules are supplied as printed hard-shell capsules containing 12.5 mg, 25 mg, 37.5 mg, and 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, and 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone. The orange gelatin capsule shells contain red iron oxide, and titanium dioxide; the caramel gelatin capsule shells contain black iron oxide, red iron oxide, titanium dioxide, and yellow iron oxide; and the yellow gelatin capsule shells contain titanium dioxide, and yellow iron oxide. The white printing ink contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide and the black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. image description