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Atazanavir (Atazanavir Sulfate)

Trade Name : Atazanavir Sulfate

NorthStar Rx LLC

CAPSULE

Strength 150 mg/1

ATAZANAVIR SULFATE HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]

Delivery Process

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Disclaimer

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 Atazanavir (Atazanavir Sulfate) which is also known as Atazanavir Sulfate and Manufactured by NorthStar Rx LLC. It is available in strength of 150 mg/1 per ml. Read more

Atazanavir (Atazanavir Sulfate) 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

Packaging and Delivery

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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.

Read more
  • No data
  • Dosage and Administration,
  • u00a0Testing Prior to Initiation and During Treatment with
  • u00a0Atazanaviru00a0 Capsules ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a010/2017
  • u00a0Dosage of Atazanavir Capsules in Pediatric Patients ()u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2017
  • u00a0Contraindications ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a03/2018u00a0u00a0u00a0u00a0u00a0
  • u00a0Warnings and Precautions
  • u00a0u00a0u00a0u00a0u00a0 Chronic Kidney Disease ()u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a010/2017
  • Atazanavir capsuleu00a0 is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg.
  • Limitations of Use:
  • Atazanavir capsuleu00a0is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg. ()
  • No data
  • Pretreatment testing:n- u00a0
  • Treatment-naive adults:
  • Treatment-experienced adults:
  • Pediatric patients:
  • Pregnancy:
  • Dosing modifications:
  • No data
  • Capsules: 150 mg, 200 mg, and 300 mg. u00a0n
  • Atazanavir capsules are contraindicated:
  • Table 6 displays drugs that are contraindicated with atazanavir capsules.u00a0u00a0
  • Atazanavir capsules are contraindicated in patients with previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. n
  • u00a0Coadministration with alfuzosin, triazolam, orally administered midazolam, ergot derivatives, rifampin, irinotecan, lurasidone (if atazanavir is coadministered with ritonavir), lovastatin, simvastatin, indinavir, cisapride, pimozide, St. John's wort, nevirapine, elbasvir/grazoprevir, glecaprevir/pibrentasvir, and sildenafil when dosed as REVATIO. n
  • No data
  • Cardiac conduction abnormalities:
  • Severe Skin Reactions:
  • Hyperbilirubinemia:
  • Hepatotoxicity:
  • Chronic kidney disease
  • Nephrolithiasis and cholelithiasis
  • The concomitant use of atazanavir/ritonavir and certain other medications may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions. (, )
  • Patients receiving atazanavir may develop new onset or exacerbations of diabetes mellitus/hyperglycemia (), immune reconstitution syndrome (), and redistribution/accumulation of body fat. ()
  • Hemophilia:
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (u22652%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. ()n n n
  • Coadministration of atazanavir can alter the concentration of other drugs and other drugs may alter the concentration of atazanavir. The potential drug-drug interactions must be considered prior to and during therapy. u00a0u00a0n
  • No data
  • Pregnancy:
  • Lactation:
  • Hepatitis B or C co-infection:
  • Renal impairment:
  • Hepatic impairment:
  • Human experience of acute overdose with atazanavir is limited. Single doses up to 1200 mg (three times the 400 mg maximum recommended dose) have been taken by healthy volunteers without symptomatic untoward effects. A single self-administered overdose of 29.2 g of atazanavir in an HIV-infected patient (73 times the 400 mg recommended dose) was associated with asymptomatic bifascicular block and PR interval prolongation. These events resolved spontaneously. At atazanavir doses resulting in high atazanavir exposures, jaundice due to indirect (unconjugated) hyperbilirubinemia (without associated liver function test changes) or PR interval prolongation may be observed Treatment of overdosage with atazanavir should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patient's clinical status. If indicated, elimination of unabsorbed atazanavir should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid removal of unabsorbed drug. There is no specific antidote for overdose with atazanavir. Since atazanavir is extensively metabolized by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicine.
  • The active ingredientu00a0 in atazanavir capsules is atazanavir sulfate, which is u00a0an HIV-1 protease inhibitor.n Theu00a0 chemicalu00a0 nameu00a0 foru00a0 atazanaviru00a0 sulfateu00a0 isu00a0 (3,8,9,12)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioicu00a0u00a0u00a0 acidu00a0u00a0 dimethylu00a0u00a0u00a0 ester,u00a0u00a0 sulfateu00a0u00a0 (1:1).u00a0u00a0u00a0 Itsu00a0u00a0 molecularu00a0u00a0u00a0 formulau00a0u00a0u00a0 is CHNOHSO, which corresponds to a molecular weight of 802.9 (sulfuricu00a0 acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:n n n n Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution inu00a0 water being about 1.9 at 24 u00b13u00b0C.n Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.854 mg, 227.805 mg, or 341.708 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C blue 2, gelatin, iron oxide black, iron oxide red, iron oxide yellow, and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and titanium dioxide.
  • No data
  • Carcinogenesisn Long-term carcinogenicity studies in mice and rats were carried out with atazanavir for two years. In the mouse study, drug-related increases in hepatocellular adenomas were found in females at 360 mg/kg/day. The systemic drug exposure (AUC) at the NOAEL (no observable adverse effect level) in females, (120 mg/kg/day) was 2.8 times and in males (80 mg/kg/day) was 2.9 times higher than those in humans at the clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir, non-pregnant patients). In the rat study, no drug-related increases in tumor incidence were observed at doses up to 1200 mg/kg/day, for which AUCs were 1.1 (males) or 3.9 (females) times those measured in humans at the clinical dose.n Mutagenesisn Atazanavir tested positive in an clastogenicity test using primary human lymphocytes, in the absence and presence of metabolic activation. Atazanavir tested negative in the Ames reverse-mutation assay, micronucleus and DNA repair tests in rats, and DNA damage test in rat duodenum (comet assay).n Impairment of Fertilityn n At the systemic drug exposure levels (AUC) 0.9 (in male rats) or 2.3 (in female rats) times that of the human clinical dose, (300 mg/day atazanavir boosted with 100 mg/day ritonavir) significant effects on mating, fertility, or early embryonic development were not observed.
  • No data
  • Atazanavir Capsules, 150 mg
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 16714-860-01
  • Atazanavir Capsules, 200 mg
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 16714-861-01
  • Atazanavir Capsules, 300 mg
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Bottles of 30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 16714-862-01
  • Store at
  • Advise the patient to read the FDA-approved patient labeling n Atazanavir is not a cure for HIV infection.u00a0Advise patients to remain under the care of a healthcare provider while using atazanavir.
  • Cardiac Conduction Abnormalities
  • Inform patients that atazanavir may produce changes in the electrocardiogram (e.g., PR prolongation). Tell patients to consult their healthcare provider if they are experiencing symptoms such as dizziness or lightheadedness .
  • Severe Skin Reaction
  • Inform patients that there have been reports of severe skin reactions (e.g., Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions) with atazanavir use. Advise patients that if signs or symptoms of severe skin reactions or hypersensitivity reactions develop, they must discontinue atazanavir and seek medical evaluation immediately n
  • Hyperbilirubinemia
  • Inform patients that asymptomatic elevations in indirect bilirubin have occurred in patients receiving atazanavir. This may be accompanied by yellowing of the skin or whites of the eyes and alternative antiretroviral therapy may be considered if the patient has cosmetic concerns .n Chronic Kidney Diseasen Inform patients that treatment with atazanavir may lead to the development of chronic kidney disease, and to maintain adequate hydration while taking atazanavir n Nephrolithiasis and Cholelithiasisn Inform patients that kidney stones and/or gallstones have been reported with atazanavir use. Some patients with kidney stones and/or gallstones required hospitalization for additional management and some had complications. Discontinuation of atazanavir may be necessary as part of the medical management of these adverse events .
  • Drug Interactions
  • Atazanavir may lead to significant interaction with someu00a0 drugs;u00a0 therefore, adviseu00a0 patientsu00a0 to report the use of any other prescription, nonprescription medication, or herbal products, particularly St. Johnu2019s wort, to their healthcare provider prior to use .n Immune Reconstitution Syndromen Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started .
  • Fat Redistribution
  • Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy includingu00a0 proteaseu00a0 inhibitorsu00a0 andu00a0 thatu00a0 theu00a0 causeu00a0 andu00a0 long-term health effects of these conditions are not known at this time n
  • Dosing Instructions
  • Advise patients to take atazanavir with food every day and take other concomitant antiretroviral therapy as prescribed. Atazanavir must always be used in combination with other antiretroviral drugs. Advise patients that they should not alter the dose or discontinue therapy without consulting with their healthcare provider. Tell patients if a dose of atazanavir is missed, they should take the dose as soon as possible and then return to their normal schedule; however, if a dose is skipped the patient should not double the next dose.
  • Pregnancy
  • Inform pregnant patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atazanavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry n n Lactationn Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk. Atazanavir can also be passed to the baby in breast milk and it is not known whether it could harm the baby n
  • Manufactured for: Northstar Rx LLCu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Memphis, TN 38141.Manufactured by: Aurobindo Pharma Limitedu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Unit-VII (SEZ)
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Mahabubnagar (Dt)-509302
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0India.M.L.No.: 22/MN/AP/2009/F/RRevised: 04/2019
  • Atazanavir Capsules
  • (A-ta-ZAN-a-vir)
  • Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with an- tazanavir capsules. For more information, seen- Who should not take n- atazanavir capsules?n- and n- What should I tell my healthcare provider before taking n- atazanavir capsules?
  • What are atazanavir capsulesn- ?
  • Atazanavir capsules are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine that is used with other antiretroviral medicines to treat HIV-1 infection in adults and children at least 6 years of age and older and weighing at least 15 kg. HIV-1 is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).
  • Atazanavir capsules should not be used in children younger than 3 months of age.
  • When used with other antiretroviral medicines to treat HIV-1 infection, atazanavir capsules may help:
  • Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
  • Atazanavir capsules do not cure HIV-1 infection or AIDS.
  • Who should not take atazanavir capsules?n n- Arrayn- Array
  • Serious problems can happen if you or your child takes any of the medicines listed above with atazanavir capsules.
  • What should I tell my healthcare provider before taking atazanavir capsules?
  • Before taking atazanavir capsules, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • Some medicines interact with atazanavir capsules. You can ask your healthcare provider or pharmacist for a list of medicines that interact with atazanavir capsules. Your healthcare provider can tell you if it is safe to take atazanavir capsules with other medicines.
  • How should I take atazanavir capsules?n
  • When your supply of atazanavir capsules starts to run lown- Arrayn- Array
  • The most common side effects of atazanavir capsules 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 atazanavir capsules. 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 atazanavir capsules?n
  • Keep atazanavir capsules and all medicines out of the reach of children.
  • General information about the safe and effective use of atazanavir capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use atazanavir capsules for a condition for which it was not prescribed. Do not give atazanavir capsules to other people, even if they have the same symptoms that you have.u00a0It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about atazanavir capsules that is written for health professionals.
  • For more information, call Northstar Rx LLC at 1-800-206-7821.
  • What are the ingredients in atazanavir capsules?
  • Active ingredient:
  • Inactive ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.
  • Manufactured for: Northstar Rx LLCu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Memphis, TN 38141.Manufactured by: Aurobindo Pharma Limitedu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit-VII (SEZ)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Mahabubnagar (Dt)-509302 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0India.M.L.No.: 22/MN/AP/2009/F/RRevised: 04/2019
  • No data
  • No data
  • Rx only
  • Atazanavir Capsules
  • 300 mg ALERT: Find out about medicines that should NOT be taken with Atazanavir Capsules.u00a0n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 30 Capsules *NORTHSTARn n

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

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Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

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Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

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GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

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Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
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