Budesonide (Pulmicort Respules)

Trade Name : PULMICORT RESPULES

AstraZeneca Pharmaceuticals LP

SUSPENSION

Strength 0.25 mg/2mL

BUDESONIDE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Budesonide (Pulmicort Respules) which is also known as PULMICORT RESPULES and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 0.25 mg/2mL per ml. Read more

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No data

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
Limitations of Use
PULMICORT RESPULES is an inhaled corticosteroid indicated for:
Limitations of Use:
Not indicated for the relief of acute bronchospasm ()

u2022
1

The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table.
Recommended dosing based on previous therapy (). Start with the lowest recommended dose:

PULMICORT RESPULES is available in three strengths, each containing 2u00a0mL: 0.25u00a0mg/2 mL, 0.5u00a0mg/2u00a0mL, and 1u00a0mg/2u00a0mL. PULMICORT RESPULES is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose RESPULES ampules together with patient instructions for use. There are 30 RESPULES ampules in a carton. Each single-dose RESPULES ampule contains 2 mL of sterile liquid suspension.
Inhalation suspension: 0.25u00a0mg/2u00a0mL, 0.5u00a0mg/2u00a0mL, 1u00a0mg/2u00a0mL ()

The use of PULMICORT RESPULES is contraindicated in the following conditions:

No data

Localized Infections:
Deterioration of Disease and Acute Asthma Episodes:
Hypersensitivity Reactions:
Immunosuppression:
Transferring Patients from Systemic Corticosteroid Therapy:
Hypercorticism and Adrenal Suppression:
Reduction in Bone Mineral Density with Long-term Administration:
Effects on Growth:
Glaucoma and Cataracts:
Paradoxical Bronchospasm:
Eosinophilic Conditions and Churg-Strauss Syndrome:

Systemic and inhaled corticosteroid use may result in the following:
Most common adverse reactions (incidence 3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash ()
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1u2013800u2013236u20139933 or FDA at 1-800-FDA-1088 or n

The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the coadministration of PULMICORT RESPULES with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) .
Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects (, )

No data

The potential for acute toxic effects following overdose of PULMICORT RESPULES is low. If inhaled corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism or growth suppression may occur n n .

Budesonide, the active component of PULMICORT RESPULES, is a corticosteroid designated chemically as (RS)-11u03b2, 16u03b1, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is CHO and its molecular weight is 430.5. Its structural formula is:
Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10.
PULMICORT RESPULES is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (Respulesu2122 ampules): 0.25u00a0mg, 0.5u00a0mg, and 1u00a0mg per 2u00a0mL RESPULES ampule. For PULMICORT RESPULES, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5u00a0L/min. The mean nebulization time was 5 minutes or less. PULMICORT RESPULES should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces .

No data

In a two-year study in Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of gliomas in male rats at an oral dose of 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/mbasis). No tumorigenicity was seen in male rats at oral doses up to 25 mcg/kg (approximately 0.2 and 0.04 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/mbasis) and in female rats at oral doses up to 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, MRHDID in adults and children 12 months to 8 years of age on a mcg/m basis). In two additional two-year studies in male Fischer and Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m basis). However, in the male Sprague- Dawley rats, budesonide caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m basis). The concurrent reference corticosteroids (prednisolone and triamcinolone acetonide) in these two studies showed similar findings.
In a 91-week study in mice, budesonide caused no treatment-related carcinogenicity at oral doses up to 200 mcg/kg (approximately equivalent to and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m basis).
Budesonide was not mutagenic or clastogenic in six different test systems: Ames microsome plate test, mouse micronucleus test, mouse lymphoma test, chromosome aberration test in human lymphocytes, sex-linked recessive lethal test in Drosophila melanogaster, and DNA repair analysis in rat hepatocyte culture.
Fertility and reproductive performance were unaffected in rats at subcutaneous doses up to 80 mcg/kg approximately equivalent to the MRHDID in adults on a mcg/m2 basis. However, it caused a decrease in prenatal viability and viability in the pups at birth and during lactation, along with a decrease in maternal body-weight gain, at subcutaneous doses of 20 mcg/kg and above approximately 0.2 times than the MRHDID in adults on a mcg/m2 basis. No such effects were noted at 5 mcg/kg (approximately 0.05 times the MRHDID in adults on a mcg/m2 basis).

Three double-blind, placebo-controlled, parallel group, randomized U.S. clinical trials of 12-weeks duration each were conducted in 1018 pediatric patients, 6 months to 8 years of age, 657 males and 361 females (798 Caucasians, 140 Blacks, 56 Hispanics, 3 Asians, 21 Others) with persistent asthma of varying disease duration (2 to 107 months) and severity. Doses of 0.25u00a0mg, 0.5u00a0mg, and 1u00a0mg administered either once or twice daily were compared to placebo to provide information about appropriate dosing to cover a range of asthma severity. A Pari-LC-Jet Plus Nebulizer (with a face mask or mouthpiece) connected to a Pari Master compressor was used to deliver PULMICORT RESPULES to patients in the 3 U.S. controlled clinical trials. The co-primary endpoints were nighttime and daytime asthma symptom scores (0-3 scale). Improvements were addressed in terms of the primary efficacy variables of changes from baseline to the double-blind treatment period in nighttime and daytime asthma symptom scores (scale 0-3) as recorded in the patient diaries. Baseline was defined as the mean of the last seven days prior to randomization). The double-blind treatment period was defined as the mean over 12 week treatment period. Each of the five doses discussed below were studied in one or two, but not all three of the U.S. studies.
Results of the 3 controlled clinical trials for recommended dosages of budesonide inhalation suspension (0.25u00a0mg to 0.5u00a0mg once or twice daily, or 1 mg once daily, up to a total daily dose of 1 mg) in 946 patients, 12 months to 8 years of age, are presented below. Statistically significant decreases in nighttime and daytime symptom scores of asthma were observed at PULMICORT RESPULES doses of 0.25u00a0mg once daily (one study), 0.25u00a0mg twice daily, and 0.5u00a0mg twice daily compared to placebo. Use of PULMICORT RESPULES resulted in statistically significant decreases in either nighttime or daytime symptom scores, but not both, at doses of 1 mg once daily, and 0.5u00a0mg once daily (one study). Symptom reduction in response to PULMICORT RESPULES occurred across gender and age. Statistically significant reductions in the need for bronchodilator therapy were also observed at all the doses of PULMICORT RESPULES studied.
Improvements in lung function were associated with PULMICORT RESPULES in the subgroup of patients capable of performing lung function testing. Statistically significant increases were seen in FEV [PULMICORT RESPULES 0.5u00a0mg once daily and 1 mg once daily (one study); 0.5u00a0mg twice daily] and morning PEF [PULMICORT RESPULES 1u00a0mg once daily (one study); 0.25u00a0mg twice daily; 0.5u00a0mg twice daily] compared to placebo.
A numerical reduction in nighttime and daytime symptom scores (0-3 scale) of asthma was observed within 2-8 days, although maximum benefit was not achieved for 4-6 weeks after starting treatment. The reduction in nighttime and daytime asthma symptom scores was maintained throughout the 12 weeks of the double-blind trials.
Patients Not Receiving Inhaled Corticosteroid Therapy
The efficacy of PULMICORT RESPULES at doses of 0.25u00a0mg, 0.5u00a0mg, and 1u00a0mg once daily was evaluated in 344 pediatric patients, 12 months to 8 years of age, with mild to moderate persistent asthma (mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.07 to 1.34) who were not well controlled by bronchodilators alone. The changes from baseline to Weeks 0-12 in nighttime asthma symptom scores are shown in Figure 1. Nighttime asthma symptom scores showed statistically significant decreases in the patients treated with PULMICORT RESPULES compared to placebo. Similar decreases were also observed for daytime asthma symptom scores.
Changes from baseline to the double-blind phase for the budesonide treatment groups compared to placebo were made using analysis of variance techniques. The model included terms for the respective changes from baseline as the dependent variable and terms for treatment, center and treatment by center interaction as exploratory variables (see Figures 1-3).
p-value u2013 0.25u00a0mg: 0.001, 0.5u00a0mg: 0.010, 1.0u00a0mg: 0.009
Patients Previously Maintained on Inhaled Corticosteroids
The efficacy of PULMICORT RESPULES at doses of 0.25u00a0mg and 0.5u00a0mg twice daily was evaluated in 133 pediatric asthma patients, 4 to 8 years of age, previously maintained on inhaled corticosteroids (mean FEV 79.5% predicted; mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.04 to 1.18; mean baseline dose of beclomethasone dipropionate of 265u00a0mcg/day, ranging between 42 to 1008u00a0mcg/day; mean baseline dose of triamcinolone acetonide of 572u00a0mcg/day, ranging between 200 to 1200u00a0mcg/day). The changes from baseline to Weeks 0-12 in nighttime asthma symptom scores are shown in Figure 2. Nighttime asthma symptom scores showed statistically significant decrease in patients treated with PULMICORT RESPULES compared to placebo. Similar decreases were also observed for daytime asthma symptom scores.
Statistically significant increases in FEV compared to placebo were observed with PULMICORT RESPULES at a dose of 0.5u00a0mg twice daily and in morning PEF for both doses (0.25u00a0mg and 0.5u00a0mg twice daily).
p-values: 0.25u00a0mg: 0.022, 0.5u00a0mg: 0.021
Patients Receiving Once-Daily or Twice-Daily Dosing
The efficacy of PULMICORT RESPULES at doses of 0.25u00a0mg once daily, 0.25u00a0mg twice daily, 0.5u00a0mg twice daily, and 1 mg once daily, was evaluated in 469 pediatric patients 12 months to 8 years of age (mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.13 to 1.31). Approximately 70% were not previously receiving inhaled corticosteroids. The changes from baseline to Weeks 0-12 in nighttime asthma symptom scores are shown in Figure 3. PULMICORT RESPULES at doses of 0.25u00a0mg and 0.5u00a0mg twice daily, and 1u00a0mg once daily, demonstrated statistically significant decreases in nighttime asthma symptom scores compared to placebo. Similar decreases were also observed for daytime asthma symptom scores.
PULMICORT RESPULES at a dose of 0.5u00a0mg twice daily resulted in statistically significant increases compared to placebo in FEV1, and at doses of 0.25u00a0mg and 0.5u00a0mg twice daily and 1u00a0mg once daily statistically significant increases in morning PEF.
The evidence supports the efficacy of the same nominal dose of PULMICORT RESPULES administered on either a once-daily or twice-daily schedule. However, when all measures are considered together, the evidence is stronger for twice-daily dosing n n .
p-values: 0.25 mg qd: 0.121, 0.25 mg bid: <0.001, 0.5 mg bid: 0.003, 1.0 mg qd: 0.005

PULMICORT RESPULES is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose RESPULES ampules together with patient instructions for use. There are 30 RESPULES ampules in a carton. Each single-dose RESPULES ampule contains 2u00a0mL of sterile liquid suspension.
PULMICORT RESPULES is available in three strengths, each containing 2u00a0mL:
PULMICORT RESPULES should be stored upright at controlled room temperature 20-25u00b0C (68-77u00b0F) [see USP], and protected from light. When an envelope has been opened, the shelf life of the unused RESPULES ampules is 2 weeks when protected. After opening the aluminum foil envelope, the unused RESPULES ampules should be returned to the aluminum foil envelope to protect them from light. Any opened RESPULES ampule must be used promptly. Gently shake the RESPULES ampule using a circular motion before use. Keep out of reach of children. Do not freeze.

No data

PULMICORT RESPULES (bew DEH so nide)
(budesonide) inhalation suspension
2u00a0mL ampules containing 0.25u00a0mg, 0.5u00a0mg, or 1u00a0mg
Read the Patient Information that comes with PULMICORT RESPULES before your child starts using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your childu2019s medical condition or treatment. If you have any questions about PULMICORT RESPULES, ask your healthcare provider or pharmacist.
What is PULMICORT RESPULES?
PULMICORT RESPULES is an inhaled corticosteroid medicine. PULMICORT RESPULES is a long-term maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.
Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms. PULMICORT RESPULES helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms.
PULMICORT RESPULES does not treat the sudden symptoms (wheezing, cough, shortness of breath, and chest pain or tightness) of an asthma attack. Always have a short-acting beta-agonist medicine (rescue inhaler) with you to treat sudden symptoms. If your child does not have an inhaled, short-acting bronchodilator, ask your healthcare provider to have one prescribed for your child.
It is not known if PULMICORT RESPULES is safe or effective in children younger than 12 months or older than 8 years.
Who should not use PULMICORT RESPULES?
Do not use PULMICORT RESPULES:
What should I tell my healthcare provider before using PULMICORT RESPULES?
Before your child uses PULMICORT RESPULES, tell your healthcare provider if your child:
PULMICORT RESPULES may not be right for children who have had any of these types of infections.
Tell your healthcare provider about all the medicine your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Using PULMICORT RESPULES with certain other medicines may affect each other causing side effects. Especially tell your healthcare provider if your child takes:
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines your child takes. Keep a list of them and show it to your healthcare provider and pharmacist when your child gets a new medicine.
How should I use PULMICORT RESPULES?
What are the possible side effects of PULMICORT RESPULES?
PULMICORT RESPULES may cause serious side effects including:
Call your healthcare provider or get medical help right away if your child has any of the serious side effects listed above.
The most common side effects of PULMICORT RESPULES include:
Tell your healthcare provider if your child has any side effect that bothers him or her or that does not go away. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to AstraZeneca at 1-800-236-9933 or the FDA at 1-800-FDA-1088 or .
How should I store PULMICORT RESPULES?
Keep PULMICORT RESPULES and all medicines out of the reach of children.
General Information about PULMICORT RESPULES
Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use PULMICORT RESPULES for a condition for which it was not prescribed. Do not give PULMICORT RESPULES 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 PULMICORT RESPULES. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about PULMICORT RESPULES that is written for health professionals.
For more information, go to www.pulmicortrespules.com or call AstraZeneca at 1-800-236-9933.
What are the ingredients in PULMICORT RESPULES?
Active ingredient: budesonide
Inactive ingredients: disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80 and water for injection.
Patient Instructions for Use
Important:
PULMICORT RESPULES is only for use with a jet nebulizer machine. Make sure you know how to use your jet nebulizer machine before your child uses PULMICORT RESPULES.
PULMICORT RESPULES is a liquid that is turned into a mist by a nebulizer and inhaled into the lungs.
The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication. Corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask.
Return the unopened PULMICORT RESPULES ampules on the strip back into the foil envelope before storing.
Figure 1
Figure 2
Figure 3
Figure 4
Revised: 10/16
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
By: AstraZeneca AB, Su00f6dertu00e4lje, Sweden
Product of Sweden
All trademarks are the property of the AstraZeneca group of companies.

NDC 0186-1988-04
Pulmicort Respulesu00ae
(budesonide inhalation suspension)
FOR INHALATION ONLY.
Rx only
Each single-dose Respulesu2122 ampule delivers 2 mL of a
sterile suspension containing 0.25 mg of micronized
budesonide plus disodium edetate, sodium chloride,
polysorbate 80, citric acid, sodium citrate and Water for
Injection.
Once a RESPULES ampule is opened, use the contents
immediately.
For use only in a jet nebulizer. Do NOT use in an
ultrasonic nebulizer.

NDC 0186-1989-04
Pulmicort Respulesu00ae
(budesonide inhalation suspension)
FOR INHALATION ONLY.
Rx only
Each single-dose Respulesu2122 ampule delivers 2 mL of a
sterile suspension containing 0.5 mg of micronized
budesonide plus disodium edetate, sodium chloride,
polysorbate 80, citric acid, sodium citrate and Water for
Injection.
Once a RESPULES ampule is opened, use the contents
immediately.
For use only in a jet nebulizer. Do NOT use in an
ultrasonic nebulizer.

NDC 0186-1990-04
Pulmicort Respulesu00ae
(budesonide inhalation suspension)
FOR INHALATION ONLY.
Rx only
Each single-dose Respulesu2122 ampule delivers 2 mL of a
sterile suspension containing 1 mg of micronized
budesonide plus disodium edetate, sodium chloride,
polysorbate 80, citric acid, sodium citrate and Water for
Injection.
Once a RESPULES ampule is opened, use the contents
immediately.
For use only in a jet nebulizer. Do NOT use in an
ultrasonic nebulizer.

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Budesonide (Pulmicort Respules)

Trade Name : PULMICORT RESPULES

SUSPENSION

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"

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Budesonide (Pulmicort Respules)

Trade Name : PULMICORT RESPULES

SUSPENSION

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)

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