Jubilant Therapeutics

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Biotechnology1 H-1B visas (FY2023)

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Focus: Small Molecules

Jubilant Therapeutics is a life sciences company focused on Small Molecules.

NeurologyCardiovascularInfectious DiseasesUnknownImmunology

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Products & Portfolio (25)

25 discontinued products not shown

CLINICAL PHARMACOLOGY Bumetanide is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg bumetanide has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of bumetanide action is the ascending limb of the loop of Henle. The mode of action has been determined through various clearance studies in both humans and experimental animals. Bumetanide inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CH 2 O) during hydration and tubular free-water reabsorption (T H 2 O) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by bumetanide, and bumetanide is somewhat more chloruretic than natriuretic. Potassium excretion is also increased by bumetanide, in a dose-related fashion. Bumetanide may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during bumetanide induced diuresis is indicative of this additional action. This is further supported by the reduction in the renal clearance of bumetanide by probenecid, associated with diminution in the natriuretic response. This proximal tubular activity does not seem to be related to an inhibition of carbonic anhydrase. Bumetanide does not appear to have a noticeable action on the distal tubule. Bumetanide decreases uric acid excretion and increases serum uric acid. Following oral administration of bumetanide the onset of diuresis occurs in 30 to 60 minutes. Peak activity is reached between 1 and 2 hours. At usual doses (1 mg to 2 mg) diuresis is largely complete within 4 hours; with higher doses, the diuretic action lasts for 4 to 6 hours. Diuresis starts within minutes following an intravenous injection and reaches maximum levels within 15 to 30 minutes. Several pharmacokinetic studies have shown that bumetanide, administered orally or parenterally, is eliminated rapidly in humans, with a half-life of between 1 and 1½ hours. Plasma protein-binding is in the range of 94% to 96%. Oral administration of carbon-14 labeled bumetanide to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug. Urinary and biliary metabolites identified in this study were formed by oxidation of the N-butyl side chain. Biliary excretion of bumetanide amounted to only 2% of the administered dose. Pediatric Pharmacology Elimination of bumetanide appears to be considerably slower in neonatal patients compared with adults, possibly because of immature renal and hepatobiliary function in this population. Small pharmacokinetic studies of intravenous bumetanide in preterm and full-term neonates with respiratory disorders have reported an apparent half-life of approximately 6 hours, with a range up to 15 hours and a serum clearance ranging from 0.2 mL/min/kg to 1.1 mL/min/kg. In a population of

edema associated with congestive heart failurehepaticrenal disease+2 more

2025

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

cetirizine hydrochloride

Post-LOE

ORAL · TABLET, CHEWABLE

these symptoms due to hay feverother upper respiratory allergies: runny nose sneezing itchywatery eyes itching of the nose+1 more

2015

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF

cetirizine hydrochloride

Post-LOE

ORAL · TABLET, CHEWABLE

these symptoms due to hay feverother upper respiratory allergies: runny nose sneezing itchywatery eyes itching of the nose+1 more

2015

CLOMIPRAMINE HYDROCHLORIDE

clomipramine hydrochloride

Post-LOE

ORAL · CAPSULE

Clinical Pharmacology: Clomipramine hydrochloride reduces the clinical signs of separation anxiety by affecting serotonergic and noradrenergic neuronal transmission in the central nervous system. While clomipramine hydrochloride can cause lethargy in dogs ( see ) its mode of action is not as a sedative. Clomipramine hydrochloride's capacity to inhibit re-uptake of serotonin in the central nervous system is believed to be the primary mechanism of action. Clomipramine hydrochloride is rapidly absorbed when administered orally. A single-dose crossover study involving 12 dogs evaluated clomipramine hydrochloride bioavailability after IV (2 mg/kg) and oral (4 mg/kg) administration in either a fed or fasted state. The administration of clomipramine hydrochloride in the presence of food resulted in an increase in the rate and extent of drug absorption as shown in the following table (mean ±SD): AUC 0-inf (nmol hr/L) C max (nmol/L) T max (hr) Absolute Bioavailability (F) Fed 1670 ± 575 601 ± 286 1.18 ± 0.32 0.21 ± 0.07 Fasted 1350 ± 447 379 ± 154 1.31 ± 0.32 0.17 ± 0.05 The absolute bioavailability is approximately 25% greater in fed dogs. The apparent terminal plasma half-life ranges from approximately 2 to 9 hours in fed and 3 to 21 hours in fasted dogs. The difference and variability in apparent half-life estimates may be attributable to prolonged drug absorption in the fasted state. The relatively large volume of distribution (3.8 ±0.8 L/kg) suggests that the drug is widely distributed throughout the body. Clomipramine is primarily metabolized in the liver.

anxietyseparation anxiety

2019

CLONIDINE HYDROCHLORIDE

clonidine hydrochloride

Post-LOE

ORAL · TABLET, EXTENDED RELEASE

CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets USP act relatively rapidly. The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent. Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a reevaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated. Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect.

the treatment of hypertensionhypertension

2018

CYCLOBENZAPRINE HYDROCHLORIDE

cyclobenzaprine hydrochloride

Post-LOE

ORAL · TABLET

CLINICAL PHARMACOLOGY Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (γ) and alpha (α) motor systems. Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation. Cyclobenzaprine caused slight to moderate increase in heart rate in animals. Pharmacokinetics Estimates of mean oral bioavailability of cyclobenzaprine range from 33% to 55%. Cyclobenzaprine exhibits linear pharmacokinetics over the dose range 2.5 mg to 10 mg, and is subject to enterohepatic circulation. It is highly bound to plasma proteins. Drug accumulates when dosed three times a day, reaching steady-state within 3 to 4 days at plasma concentrations about four-fold higher than after a single dose. At steady state in healthy subjects receiving 10 mg t.i.d. (n=18), peak plasma concentration was 25.9 ng/mL (range, 12.8 to 46.1 ng/mL), and area under the concentration-time (AUC) curve over an 8-hour dosing interval was 177 ng.hr/mL (range, 80 to 319 ng.hr/mL.) Cyclobenzaprine is extensively metabolized, and is excreted primarily as glucuronides via the kidney. Cytochromes P450 3A4, 1A2, and, to a lesser extent, 2D6, mediate N-demethylation, one of the oxidative pathways for cyclobenzaprine. Cyclobenzaprine is eliminated quite slowly, with an effective half-life of 18 hours (range 8 to 37 hours; n=18); plasma clearance is 0.7 L/min. The plasma concentration of cyclobenzaprine is generally higher in the elderly and in patients with hepatic impairment (see : and: ). Elderly In a pharmacokinetic study in elderly individuals (≥65yrs old), mean (n=10) steady-state cyclobenzaprine AUC values were approximately 1.7 fold (171.0 ng.hr/mL, range 96.1 to 255.3) higher than those seen in a group of 18 younger adults (101.4 ng.hr/mL, range 36.1 to 182.9) from another study. Elderly male subjects had the highest observed mean increase, approximately 2.4 fold (198.3 ng.hr/mL, range 155.6 to 255.3 vs. 83.2 ng.hr/mL, range 41.1 to 142.5 for younger males) while levels in elderly females were increased to a much lesser extent, approximately 1.2 fold (143.8 ng.hr/mL, range 96.1 to 196

(deferasirox) is an orally active chelator that is selective for iron (as Fe). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.

chronic iron overload in patients 10 years of ageolder with non-transfusion-dependent thalassemia (NTDT) syndromesa liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight+4 more

2025

DONEPEZIL HYDROCHLORIDE

donepezil hydrochloride

Post-LOE

ORAL · TABLET

dementia of the Alzheimer's typeAlzheimer's disease

2011

DOXEPIN HYDROCHLORIDE

doxepin hydrochloride

Post-LOE

ORAL · CAPSULE

understood.

major depressive disorder (MDD) in adults ( )

2022

DRAX EXAMETAZIME

kit for the preparation of technetium tc 99m exametazime for leukocyte labeling

Peak

INTRAVENOUS · POWDER

Radiopharmaceutical Activity

2017

DRAXIMAGE DTPA

kit for the preparation of technetium tc 99m pentetate

LOE Approaching

INJECTION · INJECTABLE

Lead Chelating Activity

pulmonary embolism

1989

DRAXIMAGE MDP-25

technetium tc 99m medronate

LOE Approaching

INJECTION · INJECTABLE

CLINICAL PHARMACOLOGY When injected intravenously, Technetium Tc 99m Medronate is rapidly cleared from the blood; about 50% of the dose is accumulated and retained by the skeleton, while the remaining 50% is excreted in the urine within 24 hours. About 10% of the injected dose remains in the blood at 1 hour post-injection, 5% at 2 hours, and less than 1% remains at 24 hours. The resultant blood clearance curve is tri-exponential with the two fastest components accounting for all but a few percent of the injected dose. Following intravenous administration of Technetium Tc 99m Medronate, skeletal uptake occurs as a function of blood flow to bone and bone efficiency in extracting the complex. Bone mineral crystals are generally considered to be hydroxyapatite, and the complex appears to have an affinity for the hydroxyapatite crystals in the bone. The rapid blood clearance provides bone to soft-tissue ratios which favor early imaging. The skeletal uptake is bilaterally symmetrical and is greater in the axial skeleton than in the long bones. Areas of abnormal osteogenesis show altered uptake making it possible to visualize a variety of osseous lesions.

1978

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Interview Prep Quick Facts

Portfolio: 95 approved products, 4 clinical trials

Top TAs: Neurology, Cardiovascular, Oncology

H-1B (2023): 1 approval

Open Roles: 10 active jobs

Portfolio Health

Peak3 (3%)

LOE Approaching10 (11%)

Post-LOE82 (86%)

95 total products

Therapeutic Area Focus

11 marketed

10 marketed

1 marketed4 pipeline

4 marketed

3 marketed

2 marketed

2 marketed

2 marketed

Marketed

Pipeline

Visa Sponsorship

Sponsors Work Visas

H-1B Petitions (FY2023)

Approved

Denied

100%

Rate

Source: USCIS H-1B Employer Data Hub

Jubilant Therapeutics

Products & Portfolio (25)

Open Jobs (10)

Assistant Manager - Logistics

Manager – Quality Control – Microbiology

Manager - Packaging Development

Manager - In Licensing

Executive - IT Applications

Principal Scientist- PRD

Group Leader-PRD-Noida

Senior Territory Manager

Principal Scientist- In vitro Biology

Group Leader

Visa Sponsorship