ajanta pharma usa inc. - Medication Listings

Tadalafil, USP an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is white to almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Tadalafil tablets, USP are available as white to off-white, oval shaped film coated tablets for oral administration. Each tablet contains 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The coating material contains hypromellose, lactose monohydrate, titanium dioxide and triacetin. tadalafil_structure

Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is white to almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Tadalafil Tablets, USP are available as light yellow to yellow coloured oval shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium lauryl sulphate, low-substituted hydroxypropyl cellulose and magnesium stearate. The color coating contains hypromellose, titanium dioxide, lactose monohydrate, iron oxide yellow, triacetin and FD&C yellow #5/tartrazine aluminium lake. structure

Terazosin hydrochloride USP, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula: Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. C 19 H 25 N 5 O 4 HCl 2H 2 O. Terazosin hydrochloride, USP is a white to pale yellow, crystalline powder. Soluble in methanol, sparingly soluble in water, slightly soluble in alcohol and in 0.1 N hydrochloric acid, very slightly soluble in isotonic saline solution and in chloroform and practically insoluble in acetone and in hexanes and has a molecular weight of 459.93. Each capsule, for oral administration, contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains ferric oxide black; the 2 mg capsule shell also contains D&C Yellow-10; the 5 mg capsule shell also contains D&C Yellow-10, D&C Red-28 and FD&C Red-40; the 10 mg capsule shell also contains D&C Yellow-10 and FD&C Green-3. Imprinting ink contains shellac, propylene glycol, butyl alcohol, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from USP. structure

Tetrabenazine is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1,3,4,6,7,11bhexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula C 19 H 27 NO 3 is represented by the following structural formula: Tetrabenazine is off-white to pale yellow powder that is sparingly soluble in methanol and soluble in chloroform. Each tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose monohydrate, ferric oxide yellow, corn starch, pregelatinized starch, magnesium stearate and talc. The 12.5 mg tetrabenazine tablets are light yellow to yellow colored, round, flat faced beveled edge, non-scored tablets debossed with ‘T1’ on one side and plain on other side. The 25 mg tetrabenazine tablets are light yellow to yellow colored, round, flat faced beveled edge, functionally scored tablets debossed with ‘T’ on both side of scored line and plain on other side. structure

Theophylline, USP is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1 H -Purine -2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is represented by the following structural formula: C 7 H 8 N 4 O 2 M.W. 180.17. This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, anhydrous lactose, magnesium stearate, polyethylene glycol and povidone. theophylline

Tolterodine tartrate extended-release capsule contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The molecular formula of tolterodine tartrate, USP is C 26 H 37 NO 7 ,. Its structure is: Tolterodine tartrate, USP is white to off-white powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14.83 mg/mL. It is soluble in methanol, and sparingly soluble in water. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate, USP. Inactive ingredients are microcrystalline cellulose, hypromellose, ethyl cellulose, medium chain triglycerides and oleic acids. The capsule shell contains FD&C Blue 2, titanium dioxide and gelatin. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, USP. Inactive ingredients are microcrystalline cellulose, hypromellose, ethyl cellulose, medium chain triglycerides and oleic acids. The capsule shell contains FD&C Blue 2, iron oxide yellow, titanium dioxide and gelatin. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, titanium dioxide, propylene glycol, and simethicone. structure

Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate is a white to off-white powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate extended-release capsules, USP contain pellets of topiramate in a capsule. The inactive ingredients are microcrystalline cellulose, hypromellose 2910, ethylcellulose, triacetin, ferric oxide, ferrosoferric oxide, talc. Each capsule shell contains hypromellose, titanium dioxide and black iron oxide, red iron oxide (25 mg, 100 mg, and 200 mg) and yellow iron oxide (50 mg, 100 mg, 150 mg, and 200 mg). Imprinting ink contains shellac, propylene glycol, butyl alcohol, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from USP. structure

Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in Dichloromethane. Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O -isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate extended-release capsules contain the following inactive ingredients: sugar spheres, hypromellose, ethyl cellulose, ammonium hydroxide, triglyceride, oleic acid, polyethylene glycol, povidone, glyceryl dibehenate, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum. The capsule shell contains: gelatin, titanium dioxide, (25 mg, 50 mg, 100 mg and 200 mg), sodium lauryl sulfate (100 mg). FD & C Blue 1, FD & C Red 3, FD & C Red 40 (25 mg, 100 mg and 200 mg), iron oxide yellow, iron oxide red (50 mg). For 25 mg, 50 mg, 100 mg (body & cap) and 200 mg (body only) strengths, imprinting black ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. For 200 mg (cap only) strength, imprinting white ink contains: shellac, ethanol, isopropyl alcohol, n-butanol, propylene glycol, ammonia solution, potassium hydroxide and titanium dioxide. structure

Valganciclovir tablets, USP contains valganciclovir hydrochloride, USP (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir tablets, USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir hydrochloride, USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone, crospovidone and stearic acid. The film-coat applied to the tablets contains hypromellose, polyethylene glycol, titanium dioxide, iron oxide red and iron oxide yellow. Valganciclovir hydrochloride, USP is a white to off-white crystalline powder with a molecular formula of C 14 H 22 N 6 O 5 ·HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir hydrochloride is 7.6. The chemical structure of valganciclovir HCl is: All doses in this insert are specified in terms of valganciclovir. structure

Valganciclovir for oral solution contains valganciclovir hydrochloride, USP (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir is available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of Valganciclovir for oral solution are sodium benzoate, tartaric acid, povidone, sodium saccharin, mannitol and fruity flavoring (banana, peach and pineapple). Composition of banana, peach and pineapple flavor powders: Maltodextrin, silicon dioxide, gum arabic (banana flavor powder and pineapple flavor powder), starch sodium octenyl succinate, triacetin and alpha-tocopherol (peach flavor powder). Valganciclovir hydrochloride, USP is a white to off-white crystalline powder with a molecular formula of C 14 H 22 N 6 O 5 ·HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir hydrochloride is 7.6. The chemical structure of valganciclovir HCl is: All doses in this insert are specified in terms of valganciclovir. structure

Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and slightly soluble in N, N-dimethyl Formamide. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13 H 13 N 3 • C 4 H 6 O 6 . The chemical structure is: Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg off-white, capsule shaped, biconvex, film-coated tablets, debossed with ‘V1’ on one side and plain on other side and a 1 mg blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘V2’ on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, maltodextrin. The film coating contains hypromellose, titanium dioxide, polyethylene glycol. 1 mg has FD&C Blue # 2 and FD&C yellow # 6. varenicline-structure

Venlafaxine extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride USP, a structurally novel antidepressant. Venlafaxine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown below. Venlafaxine hydrochloride USP is a white to off-white crystalline powder with a solubility of 683 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended-release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine extended-release tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of venlafaxine extended-release tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. Tablets contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, cellulose acetate, lactose monohydrate, mannitol, microcrystalline cellulose, magnesium stearate, povidone, polyethylene glycol. Imprinting ink contains shellac glaze, black iron oxide, propylene glycol. structure

Voriconazole USP, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is: Voriconazole is designated chemically as (α R ,βS)-α-(2,4-difluorophenyl)-5- fluoro- β -methyl- α -(1 H- 1,2,4-traizol-l-ylmethyl)-4-pyrimidineethanol with an empirical formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.31 g/mole. Voriconazole drug substance is a white or almost white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. str

Zolmitriptan tablets, USP contain zolmitriptan USP, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The molecular formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36. Zolmitriptan is a white to cream powder that is slightly soluble in water. Zolmitriptan tablets, USP are available as 2.5 mg (pink) and 5 mg (yellow) film-coated tablets for oral administration. The film-coated tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, ferric oxide yellow (2.5 mg and 5 mg tablet), ferric oxide red (2.5 mg tablet). Zolmitriptan tablets meets USP Dissolution Test 2. Structure