Venlafaxine Hydrochloride (Venlafaxine Hydrochloride)

Trade Name : Venlafaxine Hydrochloride

Teva Pharmaceuticals USA, Inc.

CAPSULE, EXTENDED RELEASE

Strength 37.5 mg/1

VENLAFAXINE HYDROCHLORIDE Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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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 Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) which is also known as Venlafaxine Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 37.5 mg/1 per ml. Read more

Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) 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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About GNH

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
  • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [].
  • In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [].
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants ()
  • Monitor for worsening and emergence of suicidal thoughts and behaviors ()
  • Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients ()
  • Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: (1)
  • Major Depressive Disorder (MDD)
  • Generalized Anxiety Disorder (GAD)
  • Social Anxiety Disorder (SAD)
  • Panic Disorder (PD)
  • Venlafaxine hydrochloride extended-release capsules should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day []. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets (spheroids).
  • Take once daily with food (). Capsules should be taken whole; do not divide, crush, chew, or dissolve ().
  • When discontinuing treatment, reduce the dose gradually (, 5.7).
  • Renal impairment: reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment ().
  • Hepatic impairment: reduce the daily dose by 50% in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% ().
  • Venlafaxine hydrochloride extended-release capsules are available in the following strengths:
  • Venlafaxine hydrochloride extended-release capsules are available as 37.5 mg, 75 mg and 150 mg strengths ().
  • Each capsule contains venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg or 150 mg of venlafaxine ().
  • No data
  • Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the venlafaxine hydrochloride extended-release capsules formulation ().
  • Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping venlafaxine hydrochloride extended-release capsules before starting an MAOI, because of the risk of serotonin syndrome (, , ).
  • No data
  • Clinical Worsening/Suicide Risk:
  • Serotonin Syndrome:
  • Elevations in Blood Pressure:
  • Abnormal Bleeding:
  • Angle Closure Glaucoma:
  • Activation of Mania/Hypomania:
  • The following adverse reactions are discussed in greater detail in other sections of the label:
  • Most common adverse reactions (incidence u2265 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal ejaculation, anorexia, constipation, erectile dysfunction, and libido decreased ().
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • No data
  • Serotonergic Drugs (e.g., MAOIs, triptans, SSRIs, other SNRIs, linezolid, lithium, tramadol, or St. Johnu2019s wort):
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ().
  • Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother ()
  • No data
  • No data
  • Venlafaxine hydrochloride extended-release capsules USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (u00b1)-1-[u03b1-[(dimethylamino)methyl]--methoxybenzyl] cyclohexanol hydrochloride. The structural formula is shown below.
  • CHNOu2022HCl M.W. 313.87
  • Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 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.
  • Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide.
  • No data
  • Carcinogenesis
  • Tumors were not increased by venlafaxine treatment in mice or rats. Venlafaxine was given by oral gavage to mice for 18 months at doses up to 120 mg/kg per day, which was 1.7 times the maximum recommended human dose on a mg/m basis. Venlafaxine was also given to rats by oral gavage for 24 months at doses up to 120 mg/kg per day. In rats receiving the 120 mg/kg dose, plasma concentrations of venlafaxine at necropsy were 1 times (male rats) and 6 times (female rats) the plasma concentrations of patients receiving the maximum recommended human dose. Plasma levels of the O-desmethyl metabolite (ODV) were lower in rats than in patients receiving the maximum recommended dose. Ou2011desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, administered by oral gavage to mice and rats for 2 years did not increase the incidence of tumors in either study. Mice received ODV at dosages up to 500/300 mg/kg/day (dosage lowered after 45 weeks of dosing). The exposure at the 300 mg/kg/day dose is 9 times that of a human dose of 225 mg/day. Rats received ODV at dosages up to 300 mg/kg/day (males) or 500 mg/kg/day (females). The exposure at the highest dose is approximately 8 (males) or 11 (females) times that of a human dose of 225 mg/day.
  • Mutagenesis
  • Venlafaxine and the major human metabolite, ODV, were not mutagenic in the Ames reverse mutation assay in bacteria or the Chinese hamster ovary/HGPRT mammalian cell forward gene mutation assay. Venlafaxine was also not mutagenic or clastogenic in the BALB/c-3T3 mouse cell transformation assay, the sister chromatid exchange assay in cultured Chinese hamster ovary cells, or in the chromosomal aberration assay in rat bone marrow. ODV was not clastogenic in the Chinese hamster ovary cell chromosomal aberration assay or in the chromosomal aberration assay in rats.
  • Impairment of Fertility
  • Reproduction and fertility studies of venlafaxine in rats showed no adverse effects of venlafaxine on male or female fertility at oral doses of up to 2 times the maximum recommended human dose of 225 mg/day on a mg/m basis. However, reduced fertility was observed in a study in which male and female rats were treated with O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, prior to and during mating and gestation. This occurred at an ODV exposure (AUC) approximately 2 to 3 times that associated with a human venlafaxine dose of 225 mg/day.
  • No data
  • Venlafaxine hydrochloride extended-release capsules USP are available as follows:
  • 37.5 mg - light-gray opaque cap/buff opaque body with u201c93u201d and u201c7384u201d on both body and cap. They are available in bottles of 30 (NDC 0093-7384-56), 90 (NDC 0093-7384-98), and 500 (NDC 0093-7384-05).
  • 75 mg - buff opaque cap/buff opaque body with u201c93u201d and u201c7385u201d on both body and cap. They are available in bottles of 30 (NDC 0093-7385-56), 90 (NDC 0093-7385-98), and 500 (NDC 0093-7385-05).
  • 150 mg - light-orange opaque cap/light-orange opaque body with u201c93u201d and u201c7386u201d on both body and cap. They are available in bottles of 30 (NDC 0093-7386-56), 90 (NDC 0093-7386-98), and 500 (NDC 0093-7386-05).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Arrayn- See FDA-approved patient labeling (Medication Guide).
  • Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with venlafaxine hydrochloride extended-release capsules and should counsel them in their appropriate use. A patient Medication Guide about u201cAntidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actionsu201d is available for venlafaxine hydrochloride extended-release capsules. The prescriber or healthcare professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and should be asked to alert their prescriber if these occur while taking venlafaxine hydrochloride extended-release capsules.
  • Suicidal Thoughts and Behaviors
  • Advise patients, their families and caregivers to look for the emergence of suicidality, worsening of depression, and other psychiatric symptoms (anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, psychomotor restlessness, hypomania, mania, other unusual changes in behavior), especially early during treatment and when the dose is adjusted up or down. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring [].
  • Concomitant Medication
  • Advise patients taking venlafaxine hydrochloride extended-release capsules not to use concomitantly other products containing venlafaxine or desvenlafaxine. Healthcare professionals should instruct patients not to take venlafaxine hydrochloride extended-release capsules with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping venlafaxine hydrochloride extended-release capsules before starting an MAOI [].
  • Serotonin Syndrome
  • Patients should be cautioned about the risk of serotonin syndrome, with the concomitant use of venlafaxine hydrochloride extended-release capsules and triptans, tramadol, amphetamines, tryptophan supplements, with antipsychotics or other dopamine antagonists, or other serotonergic agents [].
  • Elevated Blood Pressure
  • Advise patients that they should have regular monitoring of blood pressure when taking venlafaxine hydrochloride extended-release capsules [].
  • Abnormal Bleeding
  • Patients should be cautioned about the concomitant use of venlafaxine hydrochloride extended-release capsules and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [].
  • Angle Closure Glaucoma
  • Patients should be advised that taking venlafaxine hydrochloride extended-release capsules can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Preexisting glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [].
  • Activation of Mania/Hypomania
  • Advise patients, their families and caregivers to observe for signs of activation of mania/hypomania [].
  • Cardiovascular/Cerebrovascular Disease
  • Caution is advised in administering venlafaxine hydrochloride extended-release capsules to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders [].
  • Serum Cholesterol and Triglyceride Elevation
  • Advise patients that elevations in total cholesterol, LDL and triglycerides may occur and that measurement of serum lipids may be considered [].
  • Discontinuation [Symptoms]
  • Advise patients not to stop taking venlafaxine hydrochloride extended-release capsules without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping venlafaxine hydrochloride extended-release capsules [].
  • Interference with Cognitive and Motor Performance
  • Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that venlafaxine hydrochloride extended-release capsules therapy does not adversely affect their ability to engage in such activities.
  • Alcohol
  • Advise patients to avoid alcohol while taking venlafaxine hydrochloride extended-release capsules [].
  • Allergic Reactions
  • Advise patients to notify their physician if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing.
  • Pregnancy
  • Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy [].
  • Nursing
  • Advise patients to notify their physician if they are breast-feeding an infant [].
  • Residual Spheroids
  • Venlafaxine hydrochloride extended-release capsules contain spheroids, which release the drug slowly into the digestive tract. The insoluble portion of these spheroids is eliminated, and patients may notice spheroids passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the spheroids.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. N 12/2017
  • Venlafaxine (VEN la fax een) Hydrochloride Extended-Release Capsules USP
  • Read the Medication Guide that comes with before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
  • What is the most important information I should know about venlafaxine hydrochloride extended-release capsules?
  • Venlafaxine hydrochloride extended-release capsules
  • 1. Suicidal thoughts or actions:
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency.
  • Venlafaxine hydrochloride extended-release capsules may be associated with these serious side effects:
  • 2.u00a0n- Serotonin Syndrome
  • 3. Changes in blood pressure. Venlafaxine hydrochloride extended-release capsules
  • 4. Enlarged pupils (mydriasis).
  • 5. Anxiety and insomnia.
  • 6. Changes in appetite or weight.
  • 7. Manic/hypomanic episodes:
  • 8. Low salt (sodium) levels in the blood.
  • Elderly people may be at greater risk for this. Symptoms may include:
  • 9. Seizures or convulsions.
  • 10. Abnormal bleeding: Venlafaxine hydrochloride extended-release capsules
  • 11. Elevated cholesterol.
  • 12. Lung disease and pneumonia: Venlafaxine hydrochloride extended-release capsules
  • 13. Severe allergic reactions:
  • Do not stop venlafaxine hydrochloride extended-release capsules without first talking to your healthcare provider.n- venlafaxine hydrochloride extended-release capsules
  • What are venlafaxine hydrochloride extended-release capsules?
  • Venlafaxine hydrochloride extended-release capsules
  • Venlafaxine hydrochloride extended-release capsules
  • Talk to your healthcare provider if you do not think that your condition is getting better with treatment.
  • Who should not take venlafaxine hydrochloride extended-release capsules?
  • Do not take if you:
  • What should I tell my healthcare provider before taking venlafaxine hydrochloride extended-release capsules? Ask if you are not sure.
  • Before starting , tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines that you taken- Venlafaxine hydrochloride extended-release capsules
  • Your healthcare provider or pharmacist can tell you if it is safe to take with your other medicines. Do not start or stop any medicine while taking without talking to your healthcare provider first.
  • How should I take venlafaxine hydrochloride extended-release capsules?
  • What should I avoid while taking venlafaxine hydrochloride extended-release capsules?
  • Venlafaxine hydrochloride extended-release capsulesn- venlafaxine hydrochloride extended-release capsulesn- venlafaxine hydrochloride extended-release capsules
  • What are the possible side effects of venlafaxine hydrochloride extended-release capsules?
  • Venlafaxine hydrochloride extended-release capsules
  • Common possible side effects in people who take include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of . For more information, ask your healthcare provider or pharmacist.
  • CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.
  • How should I store venlafaxine hydrochloride extended-release capsules?
  • Keep venlafaxine hydrochloride extended-release capsules and all medicines out of the reach of children.
  • General information about venlafaxine hydrochloride extended-release capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use for a condition for which they were not prescribed. Do not give to other people, even if they have the same condition. They may harm them.
  • This Medication Guide summarizes the most important information about . If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about that is written for healthcare professionals.
  • For more information about call 1-888-838-2872.
  • What are the ingredients in venlafaxine hydrochloride extended-release capsules USP?
  • Active ingredient: venlafaxine hydrochloride, USP.
  • Inactive ingredients: black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. F 8/2017
  • NDCn- 7384
  • Venlafaxine
  • Hydrochloride
  • Extended-release
  • Capsules USP
  • 37.5 mg*
  • SEALED FOR YOUR PROTECTION
  • PHARMACIST: Dispense the accompanying
  • Medication Guide to each patient.
  • Rx only
  • 30 CAPSULES
  • TEVA
  • Arrayn- Array
  • NDCn- 7385
  • Venlafaxine
  • Hydrochloride
  • Extended-release
  • Capsules USP
  • 75 mg*
  • SEALED FOR YOUR PROTECTION
  • PHARMACIST: Dispense the accompanying
  • Medication Guide to each patient.
  • Rx only
  • 30 CAPSULES
  • TEVA
  • NDCn- 7386
  • Venlafaxine
  • Hydrochloride
  • Extended-release
  • Capsules USP
  • 150 mg*
  • SEALED FOR YOUR PROTECTION
  • PHARMACIST: Dispense the accompanying
  • Medication Guide to each patient.
  • Rx only
  • 30 CAPSULES
  • TEVA
  • Arrayn- Array

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