Quetiapine Fumarate (Quetiapine Fumarate)

Trade Name : QUETIAPINE FUMARATE

Accord Healthcare Inc.

TABLET, EXTENDED RELEASE

Strength 200 mg/1

QUETIAPINE FUMARATE Atypical Antipsychotic [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 Quetiapine Fumarate (Quetiapine Fumarate) which is also known as QUETIAPINE FUMARATE and Manufactured by Accord Healthcare Inc.. It is available in strength of 200 mg/1 per ml. Read more

Quetiapine Fumarate (Quetiapine Fumarate) 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.

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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
  • Arrayn- Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death ntttttn n n . Quetiapine Extended-release tablets are not approved for the treatment of patients with dementia-related psychosis n n n n n n n n n n
  • Arrayn- Suicidal Thoughts and Behavior
  • 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 n n n n n n n n n . n n n n n n n n n
  • In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber n n n n n n n n n n
  • Quetiapine Extended-release tablets are not approved for use in pediatric patients under ten years of age n n n n n n n n n n
  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Arrayn- Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine Extended-release tablets are not approved for elderly patients with dementia-related psychosis. n n n n n n n n n n
  • Arrayn- Suicidal Thoughts and Behaviors
  • Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants. n n n n n n n n n n
  • Monitor for worsening and emergence of suicidal thoughts and behaviors. n n n n n n n n n n
  • No data
  • Quetiapine Extended-release tablet is an atypical antipsychotic indicated for the treatment of:
  • Schizophrenia n n n n n n n n n n
  • Bipolar I disorder, manic or mixed episodes n n n n n n n n n n
  • Bipolar disorder, depressive episodes n n n n n n n n n n
  • Major depressive disorder, adjunctive therapy with antidepressants n n n n n n n n n n
  • No data
  • Swallow tablets whole and do not split, chew or crush n n n n n n n n n n
  • Take without food or with a light meal (approx. 300 calories) n n n n n n n n n n
  • Administer once daily, preferably in the evening n n n n n n n n n n
  • Geriatric Use:
  • Hepatic Impairment:
  • Extended-Release Tablets: 150 mg, 200 mg, 300 mg, and 400 mg n n n n n n n n n n
  • Hypersensitivity to quetiapine or to any excipients in the quetiapine extended-release tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine extended-release tablets.
  • Known hypersensitivity to quetiapine extended-release tablets or any components in the formulation. n n n n n n n n n n
  • No data
  • Cerebrovascular Adverse Reactions:
  • Neuroleptic Malignant Syndrome (NMS):
  • Metabolic Changes:
  • Tardive Dyskinesia:
  • Hypotension:
  • Increased Blood Pressure in Children and Adolescents:
  • Leukopenia, Neutropenia and Agranulocytosis:
  • Cataracts:
  • Anticholinergic (antimuscarinic) Effects:
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • Most common adverse reactions (incidence u22655% and twice placebo): n n n n n n n n n Adults: somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion n n n n n n n n n n
  • Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased n n n n n n n n n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or n n n n n n n n n nt or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.n n n n n n n n n
  • No data
  • Concomitant use of strong CYP3A4 inhibitors:
  • Concomitant use of strong CYP3A4 inducers:
  • Discontinuation of strong CYP3A4 inducers:
  • No data
  • Pregnancy:
  • Nursing Mothers:
  • No data
  • No data
  • Quetiapine fumarate is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ n n n n ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C n n n n H n n n n N n n n n O n n n n S n n n n u2022C n n n n H n n n n O n n n n and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:n n nn
  • Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.
  • Quetiapine Extended-release tablets, USP are supplied for oral administration as 150 mg (white), 200 mg (yellow), 300 mg (light yellow), and 400 mg (white). All tablets are round shaped and film coated.
  • Inactive ingredients for quetiapine extended-release tablets, USP are lactose monohydrate, sodium chloride, hydroxypropyl methylcellulose, povidone K30, talc and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, iron oxide yellow (200 and 300 mg tablets) is included in the film coating of specific strengths.
  • Each 150 mg tablet contains 173 mg of quetiapine fumarate, USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine.
  • Quetiapine Extended-release tablets, USP meet USP Dissolution Test 2.
  • No data
  • No data
  • No data
  • Store quetiapine extended-release tablets, USP at 20u00baC to 25u00baC (68 u00baF to 77 u00baF). [See USP Controlled Room Temperature].
  • See FDA-approved patient labeling (Medication Guide)
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with quetiapine extended-release tablets and should counsel them in its appropriate use. A patient Medication Guide about u201cAntidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actionsu201d is available for quetiapine extended-release tablets. The prescriber or health 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 asked to alert their prescriber if these occur while taking quetiapine extended-release tablets.
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine Extended-release tablets are not approved for elderly patients with dementia-related psychosis n n n n n
  • Suicidal Thoughts and Behaviors
  • Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. 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 and possibly changes in the medication n n n n n
  • Neuroleptic Malignant Syndrome (NMS)
  • Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. These may include muscle stiffness and high fever n n n n n
  • Hyperglycemia and Diabetes Mellitus
  • Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment n n n n n
  • Hyperlipidemia
  • Patients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment n n n n n
  • Weight Gain
  • Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly n n n n n
  • Orthostatic Hypotension
  • Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls) especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose n n n n n
  • Increased Blood Pressure in Children and Adolescents
  • Children and adolescent patients should have their blood pressure measured at the beginning of, and periodically during, treatment n n n n n
  • Leukopenia/Neutropenia
  • Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking quetiapine. Patients should be advised to talk to their doctor as soon as possible if they have a fever, flu-like symptoms, sore throat, or any other infection as this could be a result of a very low WBC, which may require quetiapine to be stopped and/or treatment to be given n n n n n
  • Interference with Cognitive and Motor Performance
  • Patients should be advised of the risk of somnolence or sedation (which may lead to falls), especially during the period of initial dose titration. Patients should be cautioned about performing any activity requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating machinery, until they are reasonably certain quetiapine therapy does not affect them adversely. n n n n n
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration n n n n n
  • Concomitant Medication
  • As with other medications, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs n n n n n
  • Pregnancy and Nursing
  • Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with quetiapine extended-release tablets n n n n n
  • Need for Comprehensive Treatment Program
  • Quetiapine extended-release tablets are indicated as an integral part of a total treatment program for adolescents with schizophrenia and pediatric bipolar disorder that may include other measures (psychological, educational, and social). Effectiveness and safety of quetiapine extended-release tablets have not been established in pediatric patients less than 13 years of age for schizophrenia or less than 10 years of age for bipolar mania. Appropriate educational placement is essential and psychosocial intervention is often helpful. The decision to prescribe atypical antipsychotic medication will depend upon the physicianu2019s assessment of the chronicity and severity of the patientu2019s symptoms. n n n n n n n
  • Manufactured For:
  • Accord Healthcare Inc.,n n n n n n1009 Slater Road,n n n n n nSuite 210-B,n n n n n nDurham, NC 27703,n n n n n nUSA.n n n n n
  • Manufactured By:
  • Intas Pharmaceuticals Limited,n n n n n nPlot No. : 457, 458,n n n n n nVillage u2013 Matoda,n n n n n nBavla Road, Ta.- Sanand,n n n n n nDist.- Ahmedabad u2013 382 210.n n n n n nIndia.n n nn
  • 10 1402 3 689218
  • Issued January 2019
  • Quetiapine Extended-Release Tabletsn n n n n n(Kwe-TYE-a-peen) n n n n
  • Read this Medication Guide before you start taking quetiapine extended-release tablets 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.
  • What is the most important information I should know about quetiapine extended-release tablets?
  • Quetiapine Extended-release tablets may cause serious side effects, including:
  • 1. risk of death in the elderly with dementia:
  • 2. risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions).
  • Talk to your or your family memberu2019s, healthcare provider about:
  • o all risks and benefits of treatment with antidepressant medicines
  • o all treatment choices for depression or other serious mental illness
  • u2022 How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
  • u2022 thoughts about suicide or dying
  • u2022 attempts to commit suicide
  • u2022 new or worse depression
  • u2022 new or worse anxiety
  • u2022 feeling very agitated or restless
  • u2022 panic attacks
  • u2022 trouble sleeping (insomnia)
  • u2022 new or worse irritability
  • u2022 acting aggressive, being angry, or violent
  • u2022 acting on dangerous impulses
  • u2022 an extreme increase in activity and talking (mania)
  • u2022 other unusual changes in behavior or mood
  • What else do I need to know about antidepressant medicines?
  • u2022Never stop an antidepressant medicine without first talking to your healthcare provider.
  • u2022Antidepressants are medicines used to treat depression and other illnesses.
  • u2022 Antidepressant medicines have other side effects.
  • u2022Antidepressant medicines can interact with other medicines.
  • u2022Not all antidepressant medicines prescribed for children are FDA approved for use in children.
  • What are quetiapine extended-release tablets ?
  • Quetiapine Extended-release tablets are a prescription medicine used to treat:
  • u2022 schizophrenia in people 13 years of age or older
  • u2022 bipolar disorder in adults, including:
  • u2022 manic episodes associated with bipolar I disorder in children ages 10 to 17 years old.
  • u2022 major depressive disorder as add-on treatment with antidepressant medicines when your healthcare provider determines that 1 antidepressant alone is not enough to treat your depression.
  • It is not known if quetiapine extended-release tablets are safe and effective in children under 10 years of age.
  • Who should not take quetiapine extended-release tablets?
  • Do not take quetiapine extended-release tablets if you are allergic to quetiapine or any of the ingredients in quetiapine extended-release tablets.
  • What should I tell my healthcare provider before taking quetiapine extended-release tablets?
  • Before you take quetiapine extended-release tablets, tell your healthcare provider if you have or have had:
  • u2022 diabetes or high blood sugar in you or your family. Your healthcare provider should check your blood sugar before you start quetiapine extended-release tablets and also during therapy.
  • u2022 high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL-cholesterol
  • u2022 low or high blood pressure
  • u2022 low white blood cell count
  • u2022 cataracts
  • u2022 seizures
  • u2022 abnormal thyroid tests
  • u2022 high prolactin levels
  • u2022 heart problems
  • u2022 liver problems
  • u2022 any other medical condition
  • u2022 pregnancy or plans to become pregnant. It is not known if quetiapine extended-release tablets will harm your unborn baby
  • u2022 breast-feeding or plans to breast-feed. Quetiapine fumarate can pass into your breast milk. You and your healthcare provider should decide if you will take quetiapine extended-release tablets or breast-feed. You should not do both.
  • u2022 if you have or have had a condition where you cannot completely empty your bladder (urinary retention), have an enlarged prostate, or constipation, or increased pressure inside your eyes.
  • Tell the healthcare provider about all the medicines that you take or recently have taken
  • Quetiapine Extended-release tablets and other medicines may affect each other causing serious side effects. Quetiapine Extended-release tablets may affect the way other medicines work, and other medicines may affect how quetiapine extended-release tablets works.
  • Tell your healthcare provider if you are having a urine drug screen because quetiapine extended-release tablets may affect your test results. Tell those giving the test that you are taking quetiapine extended-release tablets.
  • How should I take quetiapine extended-release tablets?
  • u2022
  • u2022 Take quetiapine extended-release tablets by mouth, with a light meal or without food.
  • u2022 Quetiapine Extended-release tablets should be swallowed whole and not split, chewed or crushed.
  • u2022 If you feel you need to stop quetiapine extended-release tablets, talk with your healthcare provider first.
  • u2022 If you miss a dose of quetiapine extended-release tablets, take it as soon as you remember. If you are close to your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
  • What should I avoid while taking quetiapine extended-release tablets?
  • u2022 Do not drive, operate machinery, or do other dangerous activities until you know how quetiapine extended-release tablets affects you. Quetiapine Extended-release tablets may make you drowsy.
  • u2022 Avoid getting overheated or dehydrated.
  • o Do not over-exercise.
  • o In hot weather, stay inside in a cool place if possible.
  • o Stay out of the sun. Do not wear too much or heavy clothing.
  • o Drink plenty of water.
  • u2022 Do not drink alcohol while taking quetiapine extended-release tablets. It may make some side effects of quetiapine extended-release tablets worse.
  • What are possible side effects of quetiapine extended-release tablets?
  • Quetiapine Extended-release tablets can cause serious side effects, including:
  • See u201cWhat is the most important information I should know about quetiapine extended-release tablets?u201d
  • u2022 stroke that can lead to death can happen in elderly people with dementia who take medicines like quetiapine extended-release tablets
  • u2022 neuroleptic malignant syndrome (NMS).
  • u2022 falls
  • u2022 high blood sugar (hyperglycemia).
  • Increases in blood sugar can happen in some people who take quetiapine extended-release tablets. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start quetiapine extended-release tablets and during therapy.
  • Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine extended-release tablets:
  • u2022 high fat levels in your blood (increased cholesterol and triglycerides).
  • u2022 increase in weight (weight gain).
  • u2022 movements you cannot control in your face, tongue, or other body parts (tardive dyskinesia).
  • u2022 decreased blood pressure (orthostatic hypotension),
  • u2022 increases in blood pressure in children and teenagers.
  • u2022 low white blood cell count
  • u2022 cataracts
  • u2022 seizures
  • u2022 abnormal thyroid tests:
  • u2022 increases in prolactin levels:
  • u2022 sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities
  • u2022 increased body temperature
  • u2022 difficulty swallowing
  • u2022 trouble sleeping or trouble staying asleep (insomnia), nausea, or vomiting if you suddenly stop taking quetiapine extended-release tablets.
  • The most common side effects of quetiapine extended-release tablets include:
  • u2022 dry mouth
  • u2022 constipation
  • u2022 dizziness
  • u2022 increased appetite
  • u2022 upset stomach
  • u2022 fatigue
  • u2022 stuffy nose
  • u2022 difficulty moving
  • u2022 disturbance in speech or n n n languagen nn
  • Children and Adolescents:
  • u2022tdrowsiness
  • u2022tdizziness
  • u2022t fatigue
  • u2022tstuffy nose
  • u2022tincreased appetite
  • u2022tupset stomach
  • u2022tvomiting
  • u2022tdry mouth
  • u2022ttachycardia
  • u2022tweight increased
  • These are not all the possible side effects of quetiapine extended-release tablets. For more information, ask your healthcare provider 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 quetiapine extended-release tablets?
  • u2022
  • u2022 Keep quetiapine extended-release tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of quetiapine extended-release tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine extended-release tablets for a condition for which it was not prescribed. Do not give quetiapine extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about quetiapine extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine extended-release tablets that is written for health professionals.
  • For more information, go to n n n n or call Accord Healthcare Inc. at 1-866-941-7875.n n nn
  • What are the ingredients in quetiapine extended-release tablets?
  • Active ingredient:
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Medication guide available at n n n n
  • Manufactured For:
  • Accord Healthcare Inc.,n n n n n n1009 Slater Road,n n n n n nSuite 210-B,n n n n n nDurham, NC 27703,n n n n n nUSA.n n nn
  • Manufactured By:
  • Intas Pharmaceuticals Limited,n n n n n nPlot No. : 457, 458,n n n n n nVillage u2013 Matoda,n n n n n nBavla Road, Ta.- Sanand,n n n n n nDist.- Ahmedabad u2013 382 210.n n n n n nIndia.n n nn
  • 10 1402 3 689218
  • Issued January 2019
  • PRINCIPAL DISPLAY PANEL
  • NDC 16729-n n n n n n -12n nn n nn
  • Quetiapine Extended-release Tablets USP
  • 150 mg*u00a0u00a0u00a0u00a0u00a0u00a0u00a0Once Daily
  • Rx Only
  • PHARMACIST:
  • 60 Tablets
  • PRINCIPAL DISPLAY PANEL
  • NDC 16729-n n n n n n -12n nn n nn
  • Quetiapine Extended-release Tablets USP
  • 200 mg*u00a0u00a0u00a0u00a0u00a0Once Daily
  • Rx Only
  • PHARMACIST:
  • 60 Tablets
  • PRINCIPAL DISPLAY PANEL
  • NDC 16729-n n n n n n -12n nn n nn
  • Quetiapine Extended-release Tablets USP
  • 300 mg*u00a0u00a0u00a0u00a0u00a0Once Daily
  • Rx Only
  • PHARMACIST:
  • 60 Tablets
  • PRINCIPAL DISPLAY PANEL
  • NDC 16729-n n n n n n -12n nn n nn
  • Quetiapine Extended-release Tablets USP
  • 400 mg*u00a0u00a0u00a0u00a0u00a0Once Daily
  • Rx Only
  • PHARMACIST:
  • 60 Tablets

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