Omeprazole (Omeprazole)

Trade Name : Omeprazole

Aidarex Pharmaceuticals LLC

CAPSULE, DELAYED RELEASE

Strength 40 mg/1

OMEPRAZOLE Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 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 Omeprazole (Omeprazole) which is also known as Omeprazole and Manufactured by Aidarex Pharmaceuticals LLC. It is available in strength of 40 mg/1 per ml. Read more

Omeprazole (Omeprazole) 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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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
  • Warnings and Precautions, Interaction with Clopidogrel u00a0u00a0u00a0u00a0u00a0u00a010/2012
  • Warnings and Precautions, Clostridium difficile associated u00a0u00a0u00a0u00a0u00a0u00a0u00a0 09/2012u00a0
  • diarrhea n
  • Omeprazole is a proton pump inhibitor indicated for:
  • The safety and effectiveness of omeprazole in pediatric patients < 1 year of age have not been established. n
  • Treatment in adults of duodenal ulcer and gastric ulcer n
  • Treatment in adults and children of gastroesophageal reflux disease (GERD) and maintenance of healing of erosive esophagitis n
  • Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.
  • Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
  • For patients unable to swallow an intact capsule, alternative administration options are available [See ].
  • Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size u20183u2019 hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap u2018OMEPRAZOLEu2019u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a010 mg
  • u00a0and on body u2018R157u2019 with black ink.
  • Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size u20182u2019 hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap u2018OMEPRAZOLEu2019
  • 20 mgu00a0u00a0
  • and on body u2018R158u2019 withu00a0blacku00a0ink.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size u2018Ou2019 hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap u2018OMEPRAZOLEu2019
  • 40 mg
  • and on body u2018R159u2019 with black ink.
  • Omeprazole delayed-release capsules, 10 mg, 20 mg and 40 mg n
  • Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [see ].
  • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the CONTRAINDICATIONS section of their package inserts.
  • Known hypersensitivity to any component of the formulation or substituted benzimidazoles (angioedema and anaphylaxis have occurred) n
  • No data
  • Symptomatic response does not preclude the presence of gastric malignancy n
  • Atrophic gastritis: has been noted with long-term therapy )
  • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. )
  • Avoid concomitant use of omeprazole with clopidogrel.(n
  • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ) Hypomagnesemia has been reported rarely with prolonged treatment with PPIs ()
  • Avoid concomitant use of omeprazole with St Johnu2019s Wort or rifampin due to the potential reduction in omeprazole concentrations (,)
  • Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased Choromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. ,)
  • Adults: Most common adverse reactions (incidence >2%) are
  • Pediatric patients (2 to 16 years of age):
  • Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. n
  • To report SUSPECTED ADVERSE REACTIONS, contactu00a0Dr. Reddyu2019s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. n
  • No data
  • Atazanavir and nelfinavir: omeprazole reduces plasma levels of atazanavir and nelfinavir. Concomitant use is not recommended n
  • Saquinavir: omeprazole increases plasma levels of saquinavir. Monitor for toxicity and consider dose reduction of saquinavir n
  • May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, erlotinib, ampicillin esters, and digoxin). Patients treated with omeprazole and digoxin may need to be monitored for increases in digoxin toxicity )
  • Clopidogrel: omeprazole decreases exposure to the active metabolite of clopidogrel. ,)
  • Clopidogrel: Omeprazole decreases exposure to the active metabolite of clopidogrel. , )
  • Cilostazol: omeprazole increases systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction of cilostazol.n n
  • Drugs metabolized by cytochrome P450 (e.g., diazepam, warfarin, phenytoin, cyclosporine, disulfiram, benzodiazepines): omeprazole can prolong their elimination. Monitor and determine need for dose adjustments n
  • Patients treated with proton pump inhibitors and warfarin may need to be monitored for increases in INR and prothrombin time n
  • Combined inhibitor of CYP 2C19 and 3A4 (e.g. voriconazole) may raise omeprazole levels n
  • Tacrolimus: omeprazole may increase serum levels of tacrolimus n
  • Methotrexate: Omeprazole may increase serum levels of methotrexate n n n
  • Patients with hepatic impairment:
  • Consider dose reduction, particularly for maintenance of healing erosive esophagitis n
  • Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience. [See ] Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
  • As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, contact your local Poison Control Center.
  • Single oral doses of omeprazole at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively. Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activity, body temperature, and respiratory rate and increased depth of respiration.
  • The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is CHNOS, with a molecular weight of 345.42. The structural formula is:
  • Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155u00b0C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
  • Omeprazole delayed-release capsules meets USP Drug .u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide.
  • No data
  • In two 24-month carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (about 0.7 to 57 times a human dose of 20 mg/day, as expressed on a body surface area basis) produced gastric ECL cell carcinoids in a dose-related manner in both male and female rats; the incidence of this effect was markedly higher in female rats, which had higher blood levels of omeprazole. Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with 13.8 mg omeprazole/kg/day (about 6 times a human dose of 20 mg/day, based on body surface area) for one year, and then followed for an additional year without the drug. No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of one year (94% treated vs 10% controls). By the second year the difference between treated and control rats was much smaller (46% vs 26%) but still showed more hyperplasia in the treated group. Gastric adenocarcinoma was seen in one rat (2%). No similar tumor was seen in male or female rats treated for two years. For this strain of rat no similar tumor has been noted historically, but a finding involving only one tumor is difficult to interpret. In a 52-week toxicity study in Sprague-Dawley rats, brain astrocytomas were found in a small number of males that received omeprazole at dose levels of 0.4, 2, and 16 mg/kg/day (about 0.2 to 6.5 times the human dose on a body surface area basis). No astrocytomas were observed in female rats in this study. In a 2-year carcinogenicity study in Sprague-Dawley rats, no astrocytomas were found in males or females at the high dose of 140.8 mg/kg/day (about 57 times the human dose on a body surface area basis). A 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive. A 26-week p53 (+/-) transgenic mouse carcinogenicity study was not positive.
  • Omeprazole was positive for clastogenic effects in an human lymphocyte chromosomal aberration assay, in one of two mouse micronucleus tests, and in an bone marrow cell chromosomal aberration assay. Omeprazole was negative in the Ames test, an mouse lymphoma cell forward mutation assay, and an rat liver DNA damage assay.
  • Omeprazole at oral doses up to 138 mg/kg/day in rats (about 56 times the human dose on a body surface area basis) was found to have no effect on fertility and reproductive performance.
  • In 24-month carcinogenicity studies in rats, a dose-related significant increase in gastric carcinoid tumors and ECL cell hyperplasia was observed in both male and female animals [See ] Carcinoid tumors have also been observed in rats subjected to fundectomy or long-term treatment with other proton pump inhibitors or high doses of H-receptor antagonists.
  • No data
  • 1. National Committee for Clinical Laboratory Standards. u2014Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol, 20, No. 2, NCCLS, Wayne, PA, January 2000.
  • Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size u2018Oelu2019 hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap u2018OMEPRAZOLEu2019u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0 40 mgu00a0u00a0
  • and on body u2018R159u2019 with black ink.u00a0 The capsules are supplied in bottles of 30, 60u00a0and 90.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Bottles of 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0441-30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Bottles of 60u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0441-60u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Bottles of 90u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0441-90u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Storage
  • Storeu00a0 omeprazole delayed-release capsules in a tight container protected from light and moisture.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Omeprazole delayed-release capsules should be taken before eating. Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.
  • For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.
  • Advise patients to immediately report and seek care for diarrhea that does not improve. This may be a sign of Clostridium difficile associated diarrhea [see ].
  • Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see n n n
  • Arrayn- MEDICATION GUIDE
  • Arrayn- OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
  • Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
  • What is the most important information I should know about omeprazole delayed-release capsules?
  • Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
  • Omeprazole delayed-release capsules can cause serious side effects, including:
  • Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
  • Omeprazole delayed-release capsules can have other serious side effects. See n
  • What is omeprazole delayed-release capsule?
  • Omeprazole delayed-release capsule is a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduces the amount of acid in your stomach.
  • Omeprazole delayed-release capsules are used in adults:
  • For children 2 to 16 years of age, omeprazole delayed-release capsules are used:
  • It is not known if omeprazole delayed-release capsules are safe and effective for the treatment of gastroesophageal reflux disease (GERD) in children under 1 year of age.
  • Who should not take omeprazole delayed-release capsules? n- Do not take omeprazole delayed-release capsules if you:
  • What should I tell my doctor before taking omeprazole delayed-release capsules?
  • Before you take omeprazole delayed-release capsules, tell your doctor if you:
  • Tell your doctor about all of the medicines you take
  • Especially tell your doctor if you take:
  • Ask your doctor or pharmacist for a list of these medicines if you are not sure.
  • Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I take omeprazole delayed-release capsules?
  • What are the possible side effects of omeprazole delayed-release capsules?
  • Omeprazole delayed-release capsules can cause serious side effects, including:
  • See u201cWhat is the most important information I should know about omeprazole delayed-release capsules?u201d
  • Tell your doctor right away if you develop any of these symptoms:
  • Your doctor may check the level of magnesium in your body before you start taking omeprazole delayed-release capsules or during treatment if you will be taking omeprazole delayed-release capsules for a long period of time. u00a0
  • The most common side effects with omeprazole delayed-release capsules in adults and children include:
  • In addition to the side effects listed above, the most common side effects in children 2 to 16 years of age include:
  • Other side effects: u00a0
  • Serious allergic reactions.
  • Your doctor may stop omeprazole delayed-release capsules if these symptoms happen. u00a0
  • Tell your doctor if you have any side effect that bothers you or that do not go away. These are not all the possible side effects with omeprazole delayed-release capsules. u00a0
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. u00a0
  • How should I store omeprazole delayed-release capsules?
  • Keep omeprazole delayed-release capsules and all medicines out of the reach of children.
  • General information about omeprazole delayed-release capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use omeprazole delayed-release capsules for a condition for which it was not prescribed. Do not give omeprazole delayed-release capsules to other people, even if they have the same symptoms you have. It may harm them. u00a0This Medication Guide summarizes the most important information about omeprazole delayed-release capsules. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals. u00a0
  • For more information, call 1-888-375-3784. u00a0
  • What are the ingredients in omeprazole delayed-release capsules?
  • Active ingredient in omeprazole delayed-release capsules delayed-release capsules:
  • Inactive ingredients in omeprazole delayed-release capsules
  • To reorder additional Medication Guides, contact Dr. Reddyu2019s Customer Service at 1-866-733-3952.u00a0
  • Rx Only
  • Manufactured by:
  • Dr. Reddyu2019s Laboratories Limited
  • Bachupally u2013 500 090 INDIAu00a0u00a0
  • Repackaged By :nAidarex Pharmaceuticals LLC,nCorona, CA 92880
  • Revised: 0613
  • Omeprazole Delayed-Release Capsules, USP 40 mg - Container Label

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