Fluticasone Propionate And Salmeterol (Fluticasone Propionate And Salmeterol)

Trade Name : Fluticasone Propionate and Salmeterol

Teva Pharmaceuticals USA, Inc.

POWDER, METERED

Strength 5514 ug/1ug/1

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluticasone Propionate And Salmeterol (Fluticasone Propionate And Salmeterol) which is also known as Fluticasone Propionate and Salmeterol and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 55; 14 ug/1; ug/1 per ml. Read more

Fluticasone Propionate And Salmeterol (Fluticasone Propionate And Salmeterol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta adrenergic agonist (LABA).
  • Limitations of Use
  • Fluticasone Propionate/Salmeterol MDPI is NOT indicated for the relief of acute bronchospasm.
  • Fluticasone Propionate/Salmeterol Multi-Dose Dry Powder Inhaler (MDPI) is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta-adrenergic agonist (LABA), indicated for treatment of asthma in patients aged 12 years and older. Fluticasone Propionate/Salmeterol inhalation powder should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta-adrenergic agonist (LABA). ()
  • u00a0
  • Limitations of Use
  • Not indicated for the relief of acute bronchospasm. ()
  • For oral inhalation only. ()
  • Starting dosage is based on prior asthma therapy and disease severity. ()
  • 1 inhalation of Fluticasone Propionate/Salmeterol 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg twice daily. ()
  • Do not use with a spacer or volume holding chamber. ()
  • Inhalation Powder. Fluticasone Propionate/Salmeterol MDPI is an inhalation-driven, multidose, dry powder inhaler for oral inhalation that meters 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate with 14 mcg of salmeterol from the device reservoir and delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate with 12.75 mcg of salmeterol, respectively, from the mouthpiece per actuation. The Fluticasone Propionate/Salmeterol MDPI is a white inhaler with a yellow cap, and is provided in a sealed foil pouch with desiccant .
  • Inhalation Powder: In each actuation:
  • No data
  • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ()
  • Severe hypersensitivity to milk proteins or any ingredients of Fluticasone Propionate/Salmeterol MDPI. ()
  • No data
  • LABA monotherapy increases the risk of serious asthma-related events. ()
  • Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ()
  • Do not use in combination with an additional medicine containing LABA because of risk of overdose. ()
  • Localized infections: infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ()
  • Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infection, or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ()
  • Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Fluticasone Propionate/Salmeterol. ()
  • Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Fluticasone Propionate/Salmeterol slowly. ()
  • Paradoxical bronchospasm: Discontinue Fluticasone Propionate/Salmeterol and institute alternative therapy if paradoxical bronchospasm occurs. ()
  • Use with caution in patients with cardiovascular or central nervous system disorders because of beta adrenergic stimulation. ()
  • Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. ()
  • Monitor growth of pediatric patients. ()
  • Close monitoring for glaucoma and cataracts is warranted. ()
  • Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. (, )
  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. ()
  • Use of LABA may result in the following
  • Systemic and local corticosteroid use may result in the following
  • Most common adverse reactions (reported in greater than or equal to 3% of patients) include nasopharyngitis, oral candidiasis, headache, cough and back pain. ()
  • Fluticasone Propionate/Salmeterol MDPI has been used concomitantly with other drugs, including shortu2011acting betau2011agonists, and intranasal corticosteroids, commonly used in patients with asthma without adverse drug reactions . No formal drug interaction trials have been performed with Fluticasone Propionate/Salmeterol MDPI.
  • Strong cytochrome P450u00a03A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid and cardiovascular effects.u00a0()
  • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system.u00a0()
  • Betau2011blockers: Use with caution. May block bronchodilatory effects of betau2011agonists and produce severe bronchospasm.u00a0()
  • Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with nonu2011potassiumu2011sparing diuretics may worsen with concomitant betau2011agonists.u00a0()
  • No data
  • Hepatic impairment: Monitor for systemic corticosteroid effects.u00a0()
  • This product contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to Fluticasone Propionate/Salmeterol MDPI. Treatment of overdosage consists of discontinuation of Fluticasone Propionate/Salmeterol MDPI together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective betau2011receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.
  • Fluticasone propionate
  • Chronic overdosage of fluticasone propionate may result in signs/symptoms of hypercorticism . Inhalation by healthy volunteers of a single dose of 4,000u00a0mcg of fluticasone propionate inhalation powder or single doses of 1,760u00a0or 3,520u00a0mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320u00a0mcg twice daily for 7u00a0to 15u00a0days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80u00a0mg daily for 10u00a0days in healthy volunteers and repeat oral doses up to 20u00a0mg daily for 42u00a0days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.
  • Salmeterol
  • The expected signs and symptoms with overdosage of salmeterol are those of excessive betau2011adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of betau2011adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200u00a0beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). Overdosage with salmeterol can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias.
  • As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of salmeterol.
  • Fluticasone Propionate/Salmeterol MDPI 55 mcg/14 mcg, 113 mcg/14 mcg and 232 mcg/14 mcg are combinations of fluticasone propionate and salmeterol.
  • Fluticasone Propionate
  • One active component of this product is fluticasone propionate, a corticosteroid having the chemical name -(fluoromethyl) 6u03b1,9-difluoro-11u00df,17-dihydroxy-16u03b1-methyl-3-oxoandrosta-1,4-diene-17u00df-carbothioate, 17-propionate, and the following chemical structure:
  • Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is CHFOS. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
  • Salmeterol Xinafoate
  • The other active component of this product is salmeterol xinafoate, a betau2013adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1u2011hydroxyu20112u2011naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-u03b1 -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure:
  • Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is CHNOu2022CHO. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.
  • Fluticasone Propionate/n- MDPI
  • Fluticasone Propionate/Salmeterol MDPI is a multidose dry powder inhaler (MDPI) for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream.
  • Under standardized in vitro test conditions, the Fluticasone Propionate/Salmeterol MDPI delivers 49 mcg, 100 mcg, or 202u00a0mcg of fluticasone propionate and 12.75u00a0mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds.
  • The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the Fluticasone Propionate/Salmeterol MDPI u00a0was 108.28u00a0L/min (range: 70.37u00a0to 129.24u00a0L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the Fluticasone Propionate/Salmeterol MDPI was 106.72u00a0L/min (range: 73.64u00a0to 125.51u00a0L/min).
  • No data
  • No data
  • The safety and efficacy of Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) were evaluated in 3004 patients with asthma.u00a0 The development program included 2 confirmatory trials of 12 weeks duration, a 26 week safety trial and three dose-ranging trials. The efficacy of Fluticasone Propionate/Salmeterol MDPI is based primarily on the dose-ranging trials and the confirmatory trials described below.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Patients should be given the following information:
  • Serious Asthma Events
  • Inform patients with asthma that LABA when used alone increases the risk of asthma-related
  • hospitalization and asthma-related death. Available data show that when ICS and LABA are
  • used together, such as with Fluticasone Propionate/Salmeterol MDPI, there is not a significant increase in the risk of these events.
  • Not for Acute Symptoms
  • Inform patients that Fluticasone Propionate/Salmeterol MDPI is not meant to relieve acute asthma symptoms and extra doses should not be used for that purpose. Advise patients to treat acute asthma symptoms with an inhaled, shortu2011acting betau2011agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.
  • Instruct patients to seek medical attention if they experience any of the following:
  • Tell patients they should not stop therapy with Fluticasone Propionate/Salmeterol without physician/provider guidance since symptoms may recur after discontinuation.
  • Do Not Use Additional Long-Acting Betau2011Agonists
  • Instruct patients not to use other LABA for asthma.
  • Local Effects
  • Inform patients that localized infections with occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with Fluticasone Propionate/Salmeterol MDPI, but at times therapy with Fluticasone Propionate/Salmeterol MDPI may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised to help reduce the risk of thrush.
  • Immunosuppression
  • Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections; or ocular herpes simplexn
  • Hypercorticism and Adrenal Suppression
  • Advise patients that Fluticasone Propionate/Salmeterol MDPI may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to Fluticasone Propionate/Salmeterol MDPIn
  • Immediate Hypersensitivity Reactions
  • Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Fluticasone Propionate/Salmeterol MDPI. Patients should discontinue Fluticasone Propionate/Salmeterol MDPI if such reactions occur and contact their healthcare provider or get emergency medical help. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take Fluticasone Propionate/Salmeterol MDPI.
  • Reduction in Bone Mineral Density
  • Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.
  • Reduced Growth Velocity
  • Inform patients that orally inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity when administered to adolescent patients. Physicians should closely follow the growth of adolescents taking corticosteroids by any route.
  • Ocular Effects
  • Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinationsn
  • Risks Associated with Betau2011Agonist Therapy
  • Inform patients of adverse effects associated with betau2011agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
  • Pregnancy
  • Inform patients who are pregnant or nursing that they should contact their physician about the use of Fluticasone Propionate/Salmeterol MDPI.
  • Use Daily for Best Effect
  • Patients should use Fluticasone Propionate/Salmeterol MDPI at regular intervals as directed. The daily dosage of Fluticasone Propionate/Salmeterol MDPI should not exceed 1 inhalation twice a day. Advise patients, if they miss a dose, to take their next dose at the same time they normally do and to not take 2 doses at one time. Individual patients will experience a variable time to onset and degree of symptom relief and full benefit may not be achieved until treatment has been administered for 1u00a0to 2u00a0weeks or longer. Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens. Instruct patients not to stop use of Fluticasone Propionate/Salmeterol MDPI abruptly. Patients should contact their physicians immediately if they discontinue use of Fluticasone Propionate/Salmeterol MDPI.
  • Dose Counter
  • Instruct patients that Fluticasone Propionate/Salmeterol MDPI has a dose counter that displays the number of actuations (inhalations) left in the inhaler.u00a0 When the patient receives a new inhaler, the number 60 will be displayed.u00a0 The dose counter will count down each time the mouthpiece is opened and closed.u00a0 When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist or healthcare provider for a refill of their medication.u00a0 When the dose counter reaches 0, the patient should stop using the inhaler, and dispose of it in accordance with state and local regulations.
  • Caring for and Storing the Inhaler
  • Instruct patients to not open their inhaler unless they are taking a dose.
  • Advise patients to keep their inhaler dry and clean at all times. Patient should replace inhaler if washed or placed in water. n
  • Gently wipe the mouthpiece with a dry cloth or tissue as needed.
  • Instruct patients to store the inhaler at room temperature and to avoid exposure to extreme heat, cold, or humidity.
  • Instruct patients to never take the inhaler apart.
  • Inform patients to discard this product when the dose counter displaysu00a00, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first.
  • Distributed by: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054
  • u00a92020 Teva Respiratory, u00a0LLC. All rights reserved.
  • United States Patent Nos. 6701917, 6718972, 6748947, 6871646, 7540282, 8006690, 8651103, 8714149, 8978966, 9066957, 9216260, 9415008, 9463288, 9616024, 9731087.
  • FPSPI-004
  • Rev. February 2020
  • FPSPL-004Rev.u00a0February 2020
  • Instructions for Use
  • Fluticasone Propionate and Salmeterol inhalation powder 55 mcg/14 mcg
  • Fluticasone Propionate and Salmeterol inhalation powder 113 mcg/14 mcg
  • Fluticasone Propionate and Salmeterol inhalation powder 232 mcg/14 mcg
  • for oral inhalation use
  • u00a0
  • Your Fluticasone Propionate/Salmeterol inhalation powder inhaler
  • When you are ready to use your inhaler for the first time, remove the inhaler from the foil pouch.
  • There are 2 main parts of your inhaler including the:
  • There is a dose counter in the back of the inhaler with a viewing window that shows you how many doses of medicine you have left. n
  • Figure A
  • u00a0
  • Figure B
  • Important:
  • Using your Fluticasone Propionate/Salmeterol inhalation powder inhaler:
  • Important: Make sure the cap is closed before you start using your inhaler.
  • Step 1. Open
  • u00a0
  • Figure C
  • u00a0
  • Remember:
  • Figure D
  • u00a0
  • Step 2. Inhale
  • Figure E
  • u00a0
  • Figure F
  • u00a0
  • Figure G
  • u00a0
  • u00a0
  • Step 3.u00a0n- Close
  • Figure H
  • u00a0
  • How should I store the Fluticasone Propionate/Salmeterol inhalation powder inhaler?
  • u00a0
  • Cleaning your Fluticasone Propionate/Salmeterol inhalation powder inhaler
  • u00a0
  • Replacing your Fluticasone Propionate/Salmeterol inhalation powder inhaler
  • u00a0
  • Important information
  • u00a0
  • Support
  • These Instructions for Use have been approved by the U.S. Food and Drug Administration.
  • Distributedu00a0by: Teva Pharmaceuticals USA, Inc. Parsippany, NJu00a007054
  • u00a92020 Teva Respiratory, LLC. All rights reserved.
  • FPSIFU-004
  • Rev.u00a0Februaryu00a02020
  • NDC n- 3607
  • Fluticasone Propionate
  • and Salmeterol
  • Inhalation Powder
  • 55 mcg / 14 mcg
  • FOR ORAL INHALATION ONLY
  • ATTENTION: Dispense with enclosed Medication
  • Guide.
  • With Dose Counter
  • Refer to enclosed Medication Guide and
  • Instructions for Use for detailed
  • information on product use and handling.
  • Rx only
  • 60 METERED INHALATIONS
  • 0.45 g NET CONTENTS
  • TEVA
  • u00a0
  • NDC n- 3608
  • Fluticasone Propionate
  • and Salmeterol
  • Inhalation Powder
  • 113 mcg / 14 mcg
  • FOR ORAL INHALATION ONLY
  • ATTENTION: Dispense with enclosed Medication
  • Guide.
  • With Dose Counter
  • Refer to enclosed Medication Guide and
  • Instructions for Use for detailed
  • information on product use and handling.
  • Rx only
  • 60 METERED INHALATIONS
  • 0.45 g NET CONTENTS
  • TEVA
  • u00a0
  • Arrayn- Array
  • NDC n- 3609
  • Fluticasone Propionate
  • and Salmeterol
  • Inhalation Powder
  • 232 mcg / 14 mcg
  • FOR ORAL INHALATION ONLY
  • ATTENTION: Dispense with enclosed Medication
  • Guide.
  • With Dose Counter
  • Refer to enclosed Medication Guide and
  • Instructions for Use for detailed
  • information on product use and handling.
  • Rx only
  • 60 METERED INHALATIONS
  • 0.45 g NET CONTENTS
  • u00a0
  • Arrayn- Array
  • TEVA

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