Amlodipine Besylate And Valsartan (Exforge)

Trade Name : Exforge

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 5160 mg/1mg/1

AMLODIPINE BESYLATE; VALSARTAN Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amlodipine Besylate And Valsartan (Exforge) which is also known as Exforge and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 5; 160 mg/1; mg/1 per ml. Read more

Amlodipine Besylate And Valsartan (Exforge) 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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WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue Exforge as soon as possible. ()
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()

Exforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Exforge is indicated for the treatment of hypertension, to lower blood pressure:
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

In patients not adequately controlled on monotherapy ()n
As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ()

General Considerations:
Hypertension:

5/160 mg tablets, debossed with NVR/ECE (side 1/side 2)
10/160 mg tablets, debossed with NVR/UIC
5/320 mg tablets, debossed with NVR/CSF
10/320 mg tablets, debossed with NVR/LUF
Tablets (amlodipine/valsartan mg): 5/160, 10/160, 5/320, 10/320 ()

ntttttttDo not use in patients with known hypersensitivity to any component.ntttttt
ntttttttDo not coadminister aliskiren with Exforge in patients with diabetes .ntttttt
Known hypersensitivity to any component;
Do not coadminister aliskiren with Exforge in patients with diabetes ()

No data

Hypotension: Correct volume depletion prior to initiation ()n
Increased angina and/or myocardial infarction ()n
Monitor renal function and potassium in susceptible patients (, )

In placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the Exforge-treated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with Exforge were peripheral edema and vertigo. The adverse experiences that occurred in clinical trials (u2265 2% of patients) at a higher incidence than placebo included peripheral edema, nasopharyngitis, upper respiratory tract infection, and dizziness. ()

No drug interaction studies have been conducted with Exforge and other drugs, although studies have been conducted with the individual amlodipine and valsartan components.
Amlodipine
Impact of Other Drugs on Amlodipine
CYP3A Inhibitors
Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment .
CYP3A Inducers
No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is coadministered with CYP3A inducers (e.g. rifampicin, St. John's Wort).
Sildenafil
Monitor for hypotension when sildenafil is coadministered with amlodipine [see Clinical Pharmacology (12.2)].
Impact of Amlodipine on Other Drugs
Simvastatin
Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily .
Immunosuppressants
Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate .
Valsartan
Agents Increasing Serum Potassium:
Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.
Dual Blockade of the Renin-Angiotensin System (RAS):
Do not coadminister aliskiren with Exforge in patients with diabetes. Avoid use of aliskiren with Exforge in patients with renal impairment (GFR <60 mL/min).
Lithium:

If simvastatin is coadministered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin ()
Non-Steroidal Anti-Inflammatory Drug (NSAID) use may lead to increased risk of renal impairment and loss of anti-hypertensive effect ()
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ()
Lithium: Increases in serum lithium level and lithium toxicity ()

Lactation:
Geriatric Patients:
Hepatic Impairment:

Amlodipine
Single oral doses of amlodipine maleate equivalent to 40 mg/kg and 100 mg/kg amlodipine in mice and rats, respectively, caused deaths. Single oral doses equivalent to 4 or more mg/kg amlodipine in dogs (11 or more times the maximum recommended human dose on a mg/m basis) caused a marked peripheral vasodilation and hypotension.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension. In humans, experience with intentional overdosage of amlodipine is limited. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
Valsartan
Limited data are available related to overdosage in humans. The most likely effect of overdose with valsartan would be peripheral vasodilation, hypotension, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse, and shock have been reported. If symptomatic hypotension should occur, institute supportive treatment.
Valsartan is not removed from the plasma by hemodialysis.
Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for the salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 37 times, respectively, the MRHD on a mg/m basis) (Calculations assume an oral dose of 320 mg/day and a 60 kg patient).

Exforge is a fixed combination of amlodipine and valsartan.
Exforge contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylateu2019s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is:
Its empirical formula is CHClNOu2022CHOS and its molecular weight is 567.1.
Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartanu2019s chemical name is N-(1-oxopentyl)-N-[[2u2019-(1H-tetrazol-5-yl) [1,1u2019-biphenyl]-4-yl]methyl]-L-valine; its structural formula is:
Its empirical formula is CHNO and its molecular weight is 435.5.
Exforge tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations:u00a05/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.
The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide,u00a0crospovidone, magnesium stearate, and microcrystalline cellulose. Additionally the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc, and titanium dioxide.

No data

Amlodipine
Rats and mice treated with amlodipine maleate in the diet for up to 2 years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg amlodipine/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on mg/m basis, similar to the MRHD of 10 mg amlodipine/day. For the rat, the highest dose was, on a mg/m basis, about 2.5 the MRHD (Calculations based on a 60 kg patient).
Mutagenicity studies conducted with amlodipine maleate revealed no drug-related effects at either the gene or chromosome level.
There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the MRHD of 10 mg/day on a mg/m basis).
Valsartan
There was no evidence of carcinogenicity when valsartan was administered in the diet to mice and rats for up to 2 years at concentrations calculated to provide doses of up to 160 and 200 mg/kg/day, respectively. These doses in mice and rats are about 2.4 and 6 times, respectively, the MRHD of 320 mg/day on a mg/m basis. (Calculations based on a 60 kg patient.)
Mutagenicity assays did not reveal any valsartan-related effects at either the gene or chromosome level. These assays included bacterial mutagenicity tests with and , a gene mutation test with Chinese hamster V79 cells, a cytogenetic test with Chinese hamster ovary cells, and a rat micronucleus test.
Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses of up to 200 mg/kg/day. This dose is about 6 times the MRHD on a mg/m basis.

Exforge was studied in 2 placebo-controlled and 4 active-controlled trials in hypertensive patients. In a double-blind, placebo-controlled study, a total of 1012 patients with mild-to-moderate hypertension received treatments of 3 combinations of amlodipine and valsartan (5/80, 5/160, 5/320 mg) or amlodipine alone (5 mg), valsartan alone (80, 160, or 320 mg) or placebo. All doses with the exception of the 5/320 mg dose were initiated at the randomized dose. The high dose was titrated to that dose after a week at a dose of 5/160 mg. At week 8, the combination treatments were statistically significantly superior to their monotherapy components in reduction of diastolic and systolic blood pressures.
In a double-blind, placebo-controlled study, a total of 1246 patients with mild to moderate hypertension received treatments of 2 combinations of amlodipine and valsartan (10/160, 10/320 mg), or amlodipine alone (10 mg), valsartan alone (160 or 320 mg) or placebo. With the exception of the 10/320 mg dose, treatment was initiated at the randomized dose. The high dose was initiated at a dose of 5/160 mg and titrated to the randomized dose after 1 week. At week 8, the combination treatments were statistically significantly superior to their monotherapy components in reduction of diastolic and systolic blood pressures.
In a double-blind, active-controlled study, a total of 947u00a0patients with mild to moderate hypertension who were not adequately controlled on valsartan 160 mg received treatments of 2 combinations of amlodipine and valsartan (10/160, 5/160 mg) or valsartan alone (160 mg). At week 8, the combination treatments were statistically significantly superior to the monotherapy component in reduction of diastolic and systolic blood pressures.
In a double-blind, active-controlled study, a total of 944 patients with mild to moderate hypertension who were not adequately controlled on amlodipine 10 mg received a combination of amlodipine and valsartan (10/160 mg) or amlodipine alone (10 mg). At week 8, the combination treatment was statistically significantly superior to the monotherapy component in reduction of diastolic and systolic blood pressures.
Exforge was also evaluated for safety in a 6-week, double-blind, active-controlled trial of 130 hypertensive patients with severe hypertension (mean baseline BP of 171/113 mmHg). Adverse events were similar in patients with severe hypertension and mild/moderate hypertension treated with Exforge.
A wide age range of the adult population, including the elderly was studied (range 19 to 92 years, mean 54.7 years). Women comprised almost half of the studied population (47.3%). Of the patients in the studied Exforge group, 87.6% were Caucasian. Black and Asian patients each represented approximately 4% of the population in the studied Exforge group.
Two additional double-blind, active-controlled studies were conducted in which Exforge was administered as initial therapy. In 1 study, a total of 572 black patients with moderate to severe hypertension were randomized to receive either combination amlodipine/valsartan or amlodipine monotherapy for 12 weeks. The initial dose of amlodipine/valsartan was 5/160 mg for 2 weeks with forced titration to 10/160 mg for 2 weeks, followed by optional titration to 10/320 mg for 4 weeks and optional addition of HCTZ 12.5 mg for 4 weeks. The initial dose of amlodipine was 5 mg for 2 weeks with forced titration to 10 mg for 2 weeks, followed by optional titration to 10 mg for 4 weeks and optional addition of HCTZ 12.5 mg for 4 weeks. At the primary endpoint of 8 weeks, the treatment difference between amlodipine/valsartan and amlodipine was 6.7/2.8 mmHg.u00a0
In the other study of similar design, a total of 646 patients with moderate to severe hypertensionu00a0(MSSBP of u2265 160 mmHg and < 200 mmHg) were randomized to receive either combination amlodipine/valsartan or amlodipine monotherapy for 8 weeks. The initial dose of amlodipine/valsartan was 5/160 mg for 2 weeks with forced titration to 10/160 mg for 2 weeks, followed by the optional addition of HCTZ 12.5 mg for 4 weeks. The initial dose of amlodipine was 5 mg for 2 weeks with forced titration to 10 mg for 2 weeks, followed by the optional addition of HCTZ 12.5 mg for 4 weeks. At the primary endpoint of 4 weeks, the treatment difference between amlodipine/valsartan and amlodipine was 6.6/3.9 mmHg.
There are no trials of the Exforge combination tablet demonstrating reductions in cardiovascular risk in patients with hypertension, but the amlodipine component and several ARBs, which are the same pharmacological class as the valsartan component, have demonstrated such benefits.

Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations:u00a05/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.
All strengths are packaged in bottles of 30 tablets.
5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with u201cNVRu201d on one side and u201cECEu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0488-15
10/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with u201cNVRu201d on one side and u201cUICu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0489-15
5/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with u201cNVRu201d on one side and u201cCSFu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0490-15
10/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with u201cNVRu201d on one side and u201cLUFu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0491-15
Store at 20u00b0C - 25u00b0C (68u00b0F - 77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F) [See USP Controlled Room Temperature]. Protect from moisture.

Information for Patients
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Pregnancy:n- [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)]
Lactation:n- [see Use in Specific Populations (8.2)]
Symptomatic Hypotension:n- [see Warnings and Precautions (5.2)]
Hyperkalemia:n- [see Drug Interactions (7)]
T2020-28

FDA-APPROVED PATIENT LABELING
PATIENT INFORMATION
EXFORGE (X-phorj)
(amlodipine and valsartan) Tablets
Read the Patient Information that comes with EXFORGE before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about EXFORGE, ask your doctor or pharmacist.
What is EXFORGE?
EXFORGE contains 2 prescription medicines:
EXFORGE may be used to lower high blood pressure (hypertension) in adults
EXFORGE has not been studied in children under 18 years of age.
What should I tell my doctor before taking EXFORGE?
Tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines and EXFORGE could affect each other, causing serious side affects.
Especially tell your doctor if you take:
Know the medicines you take. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine. Talk to your doctor or pharmacist before you start taking any new medicine. Your doctor or pharmacist will know what medicines are safe to take together.
How should I take EXFORGE?
What should I avoid while taking EXFORGE?
You should not take EXFORGE during pregnancy. See n
What are the possible side effects of EXFORGE?
EXFORGE may cause including:
Lie down if you feel faint or dizzy. Call your doctor right away.
The most common side effects of EXFORGE include:
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of EXFORGE. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store EXFORGE?
Keep EXFORGE and all medicines out of the reach of children.
General Information about EXFORGE
Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use EXFORGE for a condition for which it was not prescribed. Do not give EXFORGE to other people, even if they have the same symptoms that you have. It may harm them.
This patient information leaflet summarizes the most important information about EXFORGE. If you would like more information about EXFORGE, talk with your doctor. You can ask your doctor or pharmacist for information about EXFORGE that is written for health professionals. For more information go to www.EXFORGE.com or call 1-888-839-3674.
What are the ingredients in EXFORGE?
Active ingredients: Amlodipine besylate and valsartan
The inactive ingredients of all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Additionally, the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc, and titanium dioxide.
What is high blood pressure (hypertension)?
Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. EXFORGE can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure lower your chance of having a stroke or heart attack.
High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.
*Norvasc is a registered trademark of Pfizer, Inc.
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9Novartis
T2020-29Revised: March 2020

PRINCIPAL DISPLAY PANEL
Package Label u2013 5 mg*/160 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0488-15
EXFORGEu00ae (amlodipine and valsartan) Tablets
30 Tablets
*each tablet contains 6.9 mg of amlodipine besylate

PRINCIPAL DISPLAY PANEL
Package Label u2013 10 mg*/160 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0489-15
EXFORGEu00ae (amlodipine and valsartan) Tablets
30 Tablets
*each tablet contains 13.9 mg of amlodipine besylate

PRINCIPAL DISPLAY PANEL
Package Label u2013 5 mg*/320 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0490-15
EXFORGEu00ae (amlodipine and valsartan) Tablets
30 Tablets
*each tablet contains 6.9 mg of amlodipine besylate

PRINCIPAL DISPLAY PANEL
Package Label u2013 10 mg*/320 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0491-15
EXFORGEu00ae (amlodipine and valsartan) Tablets
30 Tablets
*each tablet contains 13.9 mg of amlodipine besylate

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Amlodipine Besylate And Valsartan (Exforge)

Trade Name : Exforge

TABLET, FILM COATED

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Amlodipine Besylate And Valsartan (Exforge)

Trade Name : Exforge

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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