Instructions Sildenafil 50 Ananta film-coated tablets 50 mg blister No. 4
Composition
active ingredient: sildenafil;
1 film-coated tablet contains sildenafil citrate equivalent to sildenafil 50 mg;
excipients: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, magnesium stearate, Opadry II blue 31K80956 (lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, indigo carmine (E 132)), Opadry transparent 02K19253 (hypromellose, triacetin), purified water.
Dosage form
Film-coated tablets.
Main physicochemical properties: blue, round, biconvex, film-coated tablets, debossed with “125” on one side and “J” and a breakline on the other.
Pharmacotherapeutic group
Drugs used for erectile dysfunction. Sildenafil. ATX code G04B E03.
Pharmacological properties
Pharmacodynamics
Sildenafil is an oral medication used to treat erectile dysfunction. When sexually aroused, the drug restores impaired erectile function by increasing blood flow to the penis.
The physiological mechanism that causes an erection involves the release of nitric oxide (NO) in the corpora cavernosa during sexual arousal. The released nitric oxide activates the enzyme guanylate cyclase, which stimulates an increase in cyclic guanosine monophosphate (cGMP), which in turn causes relaxation of the smooth muscle of the corpora cavernosa, facilitating blood flow.
Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for the breakdown of cGMP. The effects of sildenafil on erection are peripheral in nature. Sildenafil does not cause a direct relaxant effect on isolated human corpus cavernosum, but potently enhances the relaxant effect of NO on this tissue. When the NO/cGMP metabolic pathway is activated, which occurs during sexual stimulation, sildenafil's inhibition of PDE5 leads to an increase in cGMP levels in the corpus cavernosum. Thus, sexual arousal is required for sildenafil to produce the desired pharmacological effect.
In vitro studies have shown the selectivity of sildenafil for PDE5, which is actively involved in the erection process. The effect of sildenafil on PDE5 is more potent than on other known phosphodiesterases. This effect is 10 times more potent than the effect on PDE6, which is involved in photoconversion processes in the retina. When using the maximum recommended doses, the selectivity of sildenafil for PDE5 is 80 times higher than its selectivity for PDE1, 700 times higher than for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10 and PDE11. In particular, the selectivity of sildenafil for PDE5 is 4000 times higher than its selectivity for PDE3 - a cGMP-specific isoform of phosphodiesterase involved in the regulation of cardiac contractility.
There is evidence that specific clinical studies have been conducted to assess the time it takes for sildenafil to produce an erection in response to sexual stimulation. In clinical studies in patients taking sildenafil in the fasted state, the median time to onset of erection in patients who achieved an erection of 60% rigidity (sufficient for sexual intercourse) using phalloplethysmography was 25 minutes (range 12-37 minutes). In another study using RigiScan, sildenafil was still able to induce an erection 4-5 hours after administration.
Sildenafil causes a mild and transient decrease in blood pressure, which in most cases is not clinically evident. The mean maximum decrease in supine systolic blood pressure after oral administration of sildenafil at a dose of 100 mg was 8.4 mm Hg. The corresponding change in supine diastolic blood pressure was 5.5 mm Hg. These decreases in blood pressure are well consistent with the vasodilatory effect of sildenafil, possibly due to an increase in cGMP levels in vascular smooth muscle. Single oral doses of sildenafil up to 100 mg in healthy volunteers did not cause any clinically significant changes in the electrocardiogram.
There are data from a study of the hemodynamic effects of a single oral dose of sildenafil at a dose of 100 mg in patients with severe coronary artery disease (with stenosis of at least one coronary artery of more than 70%): the mean systolic and diastolic blood pressure at rest decreased by 7% and 6%, respectively, relative to baseline. The mean pulmonary systolic pressure decreased by 9%. Sildenafil did not lead to changes in cardiac output and did not reduce blood flow in stenosed coronary arteries.
Mild and transient color vision impairment (blue/green) was observed in some patients 1 hour after administration of sildenafil 100 mg. These effects completely disappeared 2 hours after administration of the drug. The possible mechanism of this change in color vision is associated with inhibition of PDE6, which is involved in the photoconversion cascade of reactions in the retina. Sildenafil does not affect visual acuity or contrast sensitivity. In studies involving patients with documented macular degeneration, the use of sildenafil (single dose of 100 mg) did not cause significant changes in the results of visual tests (visual acuity, Amsler grid, simulated traffic light color recognition, Humphrey perimeter and photostress).
A single oral dose of sildenafil 100 mg in healthy volunteers had no effect on sperm motility or morphology.
There are clinical trial data on the use of sildenafil in patients aged 19 to 87 years. The following patient groups were represented: elderly patients, patients with arterial hypertension, patients with diabetes mellitus, coronary heart disease, hyperlipidemia, spinal cord injury, depression, transurethral resection of the prostate, radical prostatectomy. Patient groups that were not adequately represented or not included in clinical trials: patients after pelvic surgery, patients after radiation therapy, patients with severe renal or hepatic insufficiency, and patients with certain cardiovascular diseases.
In fixed-dose studies, the number of patients reporting improvement in erectile function was higher than in the placebo group. In controlled clinical trials, the rate of sildenafil discontinuation was low and similar to that in the placebo group.
In all these studies, patients reported improvements with sildenafil in psychogenic erectile dysfunction, mixed erectile dysfunction, organic erectile dysfunction, elderly patients, diabetes mellitus, coronary heart disease, hypertension, transurethral resection of the prostate, radical prostatectomy, spinal cord injury, and depression. The safety and efficacy of sildenafil were confirmed by data from these long-term studies.
Pharmacokinetics
Absorption. Sildenafil is rapidly absorbed. Peak plasma concentrations are reached within 30-120 minutes (median 60 minutes) after oral administration in the fasted state. The mean absolute oral bioavailability is 41% (range 25-63%). Over the recommended dose range (25-100 mg), the AUC and Cmax of sildenafil increase proportionally with dose after oral administration.
When sildenafil is taken with food, the extent of absorption is reduced with a mean prolongation of Tmax to 60 minutes and a mean decrease in Cmax by 29%.
Distribution. The mean steady-state volume of distribution (Vd) is 105 liters, indicating distribution of the drug into body tissues. After a single oral dose of 100 mg sildenafil, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (the coefficient of variation is 40%). Since the binding of sildenafil and its major N-desmethyl metabolite to plasma proteins reaches 96%, the mean maximum plasma concentration of free sildenafil reaches 18 ng/mL (38 nmol). The extent of binding to plasma proteins is independent of the total concentrations of sildenafil.
There is evidence that in healthy volunteers who used sildenafil once at a dose of 100 mg, less than 0.0002% (average 188 ng) of the applied dose was detected in the ejaculate after 90 minutes.
Metabolism. Sildenafil is metabolized primarily by the hepatic microsomal isoenzymes CYP3A4 (major pathway) and CYP2C9 (minor pathway). The major circulating metabolite is formed by N-demethylation of sildenafil. The selectivity of the metabolite for PDE5 is comparable to that of sildenafil, and the activity of the metabolite for PDE5 is approximately 50% of that of the parent compound. The plasma concentration of this metabolite is approximately 40% of that of sildenafil in plasma. The N-demethylated metabolite undergoes further metabolism and has a half-life of approximately 4 hours.
Elimination: The total clearance of sildenafil is 41 l/h, resulting in a half-life of 3-5 hours. After both oral and intravenous administration, sildenafil is excreted as metabolites primarily in the feces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).
Renal impairment. In patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min), the pharmacokinetics of sildenafil were unchanged after a single oral dose of 50 mg. The mean AUC and Cmax of the N-desmethyl metabolite were increased by 126% and 73%, respectively, compared with those in age-matched volunteers without renal impairment. However, due to high interindividual variability, these differences were not statistically significant. In volunteers with severe renal impairment (creatinine clearance below 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88%, respectively, compared with age-matched volunteers without renal impairment. In addition, the AUC and Cmax values of the N-demethylated metabolite were significantly increased by 79% and 200%, respectively.
Hepatic impairment: In volunteers with mild to moderate liver cirrhosis (Child-Pugh class A and B), sildenafil clearance was reduced, resulting in increased AUC (84%) and Cmax (47%) compared to age-matched volunteers without hepatic impairment. The pharmacokinetics of sildenafil in patients with severe hepatic impairment have not been studied.
Indication
Treatment of erectile dysfunction, defined as the inability to achieve and maintain a penile erection necessary for successful sexual intercourse.
Sexual arousal is required for the drug to be effective.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Concomitant use with nitric oxide donors (such as amyl nitrite) or nitrates in any form is contraindicated, as sildenafil is known to affect the nitric oxide/cyclic guanosine monophosphate (cGMP) metabolic pathways and potentiate the hypotensive effect of nitrates.
The concomitant use of PDE5 inhibitors (including sildenafil) with guanylate cyclase stimulators such as riociguat is contraindicated as it may lead to symptomatic hypotension (see section 4.5).
Conditions in which sexual activity is not recommended (e.g. severe cardiovascular disorders such as unstable angina and severe heart failure). Loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy, whether or not this pathology is associated with previous use of PDE5 inhibitors. Severe hepatic impairment, arterial hypotension (blood pressure below 90/50 mm Hg), recent stroke or myocardial infarction and known hereditary degenerative retinal diseases such as retinitis pigmentosa (a small number of such patients have genetic disorders of retinal phosphodiesterases), since the safety of sildenafil has not been studied in these subgroups of patients.
Interaction with other medicinal products and other types of interactions
Effects of other drugs on sildenafil.
Sildenafil is metabolized primarily by cytochrome P450 (CYP) isoform 3A4 (major pathway) and isoform 2C9 (minor pathway). Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance.
Sildenafil clearance has been shown to be reduced when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). Although no increase in adverse events was observed when sildenafil was co-administered with CYP3A4 inhibitors, the recommended starting dose of sildenafil is 25 mg.
Co-administration of the HIV protease inhibitor ritonavir, a very potent P450 inhibitor, at steady state (500 mg once daily) with sildenafil (single dose of 100 mg) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1000% (11-fold) increase in sildenafil plasma AUC. After 24 hours, plasma sildenafil levels were still approximately 200 ng/ml compared to approximately 5 ng/ml with sildenafil alone, consistent with the significant effect of ritonavir on a wide range of P450 substrates. Sildenafil does not affect the pharmacokinetics of ritonavir. Based on these pharmacokinetic data, co-administration of sildenafil and ritonavir is not recommended; in any case, the maximum dose of sildenafil should not exceed 25 mg within 48 hours.
When sildenafil (100 mg once daily) was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), a 182% increase in systemic exposure (AUC) to sildenafil was observed. In healthy male volunteers, there was no effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, and subsequent half-life of sildenafil or its major circulating metabolite. Cimetidine (a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor) at a dose of 800 mg when co-administered with sildenafil at a dose of 50 mg in healthy volunteers resulted in a 56% increase in plasma concentrations of sildenafil.
Grapefruit juice is a weak inhibitor of CYP3A4 in the intestinal wall and may cause a modest increase in plasma levels of sildenafil.
Single administration of antacids (magnesium hydroxide/aluminum hydroxide) does not affect the bioavailability of sildenafil.
Although specific drug interaction studies have not been conducted, population pharmacokinetic analysis suggests that sildenafil pharmacokinetics were not altered by concomitant use of drugs belonging to the CYP2C9 inhibitor group (tolbutamide, warfarin, phenytoin), CYP2D6 inhibitor group (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and thiazide-like diuretics, loop and potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, calcium antagonists, beta-adrenoceptor antagonists, or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Nicorandil is a hybrid of a calcium channel activator and a nitrate. The nitrate component makes it possible for it to have a serious interaction with sildenafil.
Effect of sildenafil on other drugs.
Sildenafil is a weak inhibitor of cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μmol). Since peak plasma concentrations of sildenafil are approximately 1 μmol, the effect of the drug on the clearance of substrates of these isoenzymes is unlikely.
There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline and dipyridamole.
Since sildenafil is known to have an effect on nitric oxide/cyclic guanosine monophosphate (cGMP) metabolism, it has been found that this drug potentiates the hypotensive effect of nitrates, therefore its simultaneous use with nitric oxide donors or with nitrates in any form is contraindicated.
Concomitant use of sildenafil and alpha-blockers may lead to symptomatic hypotension in some susceptible patients. This reaction most often occurs within 4 hours of sildenafil administration. In a specific drug interaction study, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg and 100 mg) were administered concomitantly to patients with benign prostatic hyperplasia who were stabilized on doxazosin. In these populations, mean additional reductions in supine blood pressure of 7/7 mmHg, 9/5 mmHg and 8/4 mmHg and mean reductions in standing blood pressure of 6/6 mmHg, 11/4 mmHg and 4/5 mmHg, respectively, were observed. Symptomatic orthostatic hypotension has occasionally been reported with concomitant use of sildenafil and doxazosin in patients stabilized on doxazosin. These reports included dizziness and fainting, but without syncope.
No significant interactions were observed with the concomitant use of sildenafil (50 mg) and tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by CYP2C9.
Sildenafil (50 mg) did not prolong bleeding time induced by acetylsalicylic acid (150 mg).
Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers at mean maximum blood ethanol levels of 80 mg/dL.
In patients taking sildenafil, no differences in the side effect profile compared to placebo were observed when such classes of antihypertensive drugs as diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive drugs (vasodilators and centrally acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenergic blockers were used concomitantly. In a dedicated interaction study, when sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, an additional reduction in supine systolic blood pressure of 8 mm Hg was observed. The corresponding reduction in diastolic blood pressure was 7 mm Hg. These additional reductions in blood pressure were comparable in magnitude to those observed with sildenafil alone in healthy volunteers.
Riociguat. Studies have shown an additive systemic blood pressure lowering effect when PDE5 inhibitors are used concomitantly with riociguat. No beneficial clinical effect was observed in patients who participated in the studies from the concomitant use of PDE5 inhibitors with riociguat. Concomitant use of riociguat with PDE5 inhibitors (including sildenafil) is contraindicated (see section 4.3).
Application features
Before starting therapy, the patient's medical history should be collected and a physical examination should be performed to diagnose erectile dysfunction and determine its possible causes.
Since sexual activity carries a certain cardiac risk, the physician should assess the patient's cardiovascular status before initiating any treatment for erectile dysfunction. Sildenafil has a vasodilating effect, manifested by a mild and transient decrease in blood pressure. Before prescribing sildenafil, the physician should carefully consider whether this effect may have an adverse effect on patients with certain underlying diseases, especially in combination with sexual activity. Patients with increased sensitivity to vasodilators include patients with obstruction of the outflow tract of the left ventricle (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy) or patients with the rare syndrome of multiple system atrophy, one of the manifestations of which is severe dysregulation of blood pressure by the autonomic nervous system.
The drug potentiates the hypotensive effect of nitrates.
Serious cardiovascular adverse reactions, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, and hypotension, have been reported in association with drug use. Most, but not all, patients had cardiovascular risk factors. Many of these adverse reactions occurred during or immediately after sexual intercourse, and only a few occurred shortly after drug use without sexual activity. Therefore, it is not possible to determine whether these adverse reactions are directly related to the risk factors or are caused by other factors.
Erectile dysfunction drugs, including sildenafil, should be prescribed with caution in patients with anatomical deformities of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or in patients with conditions predisposing to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
The safety and efficacy of concomitant use of sildenafil with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
Visual disturbances and cases of non-arteritic anterior ischemic optic neuropathy have been reported with the use of sildenafil and other PDE5 inhibitors. Patients should be advised that in the event of sudden visual impairment, the drug should be discontinued and a physician should be consulted immediately.
Concomitant use of sildenafil and ritonavir is not recommended.
Sildenafil should be used with caution in patients taking alpha-adrenergic blockers, as the combination may lead to symptomatic hypotension in some susceptible patients. Symptomatic hypotension usually occurs within 4 hours of sildenafil administration. To minimize the risk of orthostatic hypotension, sildenafil therapy should only be initiated in hemodynamically stable patients taking alpha-adrenergic blockers. The recommended starting dose for such patients is 25 mg sildenafil. In addition, patients should be informed of what to do if symptoms of orthostatic hypotension occur.
Studies in human platelets have shown that sildenafil potentiates the antiaggregatory effects of sodium nitroprusside in vitro. There is no information on the safety of sildenafil in patients with coagulation disorders or acute peptic ulcer. Therefore, sildenafil should only be used in these patients after careful consideration of the benefit-risk ratio.
The film-coating of the tablets contains lactose monohydrate. Men with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Concomitant use with antihypertensive drugs. Sildenafil has a systemic vasodilator effect and may further reduce blood pressure in patients taking antihypertensive drugs. In a separate drug interaction study, concomitant administration of amlodipine (5 mg or 10 mg) and oral sildenafil (100 mg) resulted in a mean additional reduction in systolic blood pressure of 8 mm Hg and diastolic blood pressure of 7 mm Hg.
Sexually transmitted diseases. Sildenafil does not protect against sexually transmitted diseases. Consideration should be given to instructing patients on the necessary precautions to protect against sexually transmitted diseases, including human immunodeficiency virus.
Fertility: No effects on sperm morphology or motility were observed after administration of a 100 mg dose to healthy volunteers.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted on the effect of the drug on the ability to drive vehicles and work with other mechanisms.
Since dizziness and visual disturbances have been reported with sildenafil, patients should be aware of their individual reaction to the drug before driving or operating machinery.
Use during pregnancy or breastfeeding
The drug is not intended for use by women.
Method of administration and doses
The drug is administered orally.
Sexual arousal is required for the drug to be effective.
Adults.
The recommended dose of the drug is 50 mg and is used, if necessary, approximately one hour before sexual intercourse. Depending on the effectiveness and tolerability of the drug, the dose can be increased to 100 mg or reduced to 25 mg. The maximum recommended dose is 100 mg.
The maximum recommended frequency of use of the drug is 1 time per day. When the drug is used with food, the effect of the drug may occur later than when it is used on an empty stomach.
Elderly patients.
There is no need for dose adjustment in elderly patients.
Patients with renal failure.
For patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min), the recommended dose is the same as that given above in the Adults section.
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance below 30 ml/min), the recommended dose is 25 mg. Depending on the efficacy and tolerability of the drug, the dose may be increased to 50 mg and 100 mg.
Patients with liver failure.
Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis), the recommended dose is 25 mg. Depending on the efficacy and tolerability of the drug, the dose may be increased to 50 mg and 100 mg.
Patients taking other medicines (e.g. ketoconazole, erythromycin, cimetidine, ritonavir) Detailed information is provided in the section “Interaction with other medicinal products and other types of interactions”.
The recommended starting dose for patients taking CYP3A4 inhibitors, with the exception of ritonavir, the use of which with sildenafil is not recommended, is 25 mg.
To minimize the risk of orthostatic hypotension, patients taking alpha-adrenergic blockers should be stabilized before starting sildenafil. The recommended starting dose of sildenafil is 25 mg.
Children
The drug is not indicated for use by persons under 18 years of age.
Overdose
When using a single dose of sildenafil up to 800 mg, adverse reactions were similar to those observed with the use of sildenafil in lower doses, but were more frequent and more severe. The use of sildenafil at a dose of 200 mg did not lead to increased efficacy, but caused an increase in the number of cases of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, visual disturbances).
In the event of overdose, standard supportive measures should be employed as necessary. Acceleration of sildenafil clearance by hemodialysis is unlikely due to the high degree of binding of the drug to plasma proteins and the lack of urinary elimination of sildenafil.
Adverse reactions
The most common adverse reactions were headache, flushing, dyspepsia, visual disturbances, nasal congestion, dizziness, and color vision disturbances.
All clinically significant adverse reactions observed in studies at an incidence greater than placebo are listed below by system organ class and frequency: very common (≥ 1/10), common (≥ 100 to < 1/10), uncommon (≥ 1,000 to < 1/100) and rare (≥ 10,000 to < 1/1,000). In addition, the frequency of clinically significant adverse reactions reported during post-marketing experience is not known.
From the nervous system: very often - headache; often - dizziness; infrequently - drowsiness, hypoesthesia; rarely - stroke, fainting; frequency unknown - transient ischemic attack, seizures, recurrent seizures.
On the part of the organs of vision: often - visual disturbances, impaired color perception; infrequently - conjunctival disorders, lacrimation disorders, other disorders of the organs of vision; frequency unknown - non-arteritic anterior ischemic optic neuropathy, retinal vascular occlusion, visual field defects.
From the side of the organs of hearing and vestibular apparatus: infrequently - dizziness, tinnitus; rarely - deafness (several cases of sudden hearing loss or sudden hearing loss have been reported in the case of the use of PDE5 inhibitors, including sildenafil).
Vascular disorders: often – flushing of the face; rarely – hypertension, hypotension.
On the part of the heart: infrequently - palpitations, tachycardia; rarely - myocardial infarction, atrial fibrillation; frequency unknown - ventricular arrhythmia, unstable angina, sudden cardiac death.
From the respiratory system, thoracic organs and mediastinum: often - nasal congestion; rarely - epistaxis.
On the part of the digestive system: often - dyspepsia; infrequently - nausea, vomiting, dry mouth.
Skin and subcutaneous tissue disorders: uncommon – skin rash; frequency unknown – Stevens-Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: uncommon – myalgia.
From the reproductive system and mammary glands: not known - priapism, prolonged erection.
General disorders: infrequently - chest pain, increased fatigue.
Examination: uncommon – increased heart rate.
Expiration date
2 years.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 25 °C.
Packaging
4 tablets in a blister, 1 blister in a pack.
Vacation category
According to the recipe.
Producer
Artura Pharmaceuticals Pvt. Ltd.
Location of the manufacturer and its business address
1505 Portia Road, Sri City SEZ, Setyavedu Mandal, Chittoor District - 517 588, Andhra Pradesh, India
