R-Pharm US

NJ - Princeton

Biotechnology1 H-1B visas (FY2023)

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Focus: Acquiring Small Products

R-Pharm US is a life sciences company focused on Acquiring Small Products.

CardiovascularNeurologyInfectious DiseasesOncologyRespiratory

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Products & Portfolio (12)

38 discontinued products not shown

AMPHADASE

hyaluronidase

LOE Approaching

INJECTION · INJECTABLE

agent, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. Hyaluronic acid is also present in the capsules of type A and C hemolytic streptococci. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C 1 of an N-acetylglucosamine moiety and C 4 of a glucuronic acid moiety. This temporarily decreases the viscosity of the cellular cement and promotes dispersion of injected fluids or of localized transudates or exudates, thus facilitating their absorption. Hyaluronidase cleaves glycosidic bonds of hyaluronic acid and, to a variable degree, some other acid mucopolysaccharides of the connective tissue. The activity is measured in vitro by monitoring the decrease in the amount of an insoluble serum albumin-hyaluronic acid complex as the enzyme cleaves the hyaluronic acid component.

2004

ANTIVERT

meclizine hydrochloride

LOE Approaching

ORAL · TABLET

H1 receptor.

vertigo associated with diseases affecting the vestibular system in adults

INTRAVENOUS · INJECTABLE

high-affinity antagonist of human substance P/neurokinin 1 (NK 1 ) receptors. Aprepitant has little or no affinity for serotonin (5-HT 3 ), dopamine, and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV). Aprepitant has been shown in animal models to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin, via central actions. Animal and human Positron Emission Tomography (PET) studies with aprepitant have shown that it crosses the blood brain barrier and occupies brain NK 1 receptors. Animal and human studies show that aprepitant augments the antiemetic activity of the 5-HT 3 -receptor antagonist ondansetron and the corticosteroid dexamethasone and inhibits both the acute and delayed phases of cisplatin-induced emesis.

AQUASOL A

water-miscible retinyl palmitate

LOE Approaching

INJECTION · INJECTABLE

CLINICAL PHARMACOLOGY Beta-carotene, retinol, and retinal have effective and reliable vitamin A activity. Retinal and retinol are in chemical equilibrium in the body and have equivalent antixerophthalmic activity. Retinal combines with the rod pigment, opsin, in the retina to form rhodopsin, necessary for visual dark adaptation. Vitamin A prevents retardation of growth and preserves the epithelial cells' integrity. Normal adult liver storage is sufficient to satisfy two years' requirements of vitamin A. Vitamin A is readily absorbed from the gastrointestinal tract, where the biosynthesis of vitamin A from beta-carotene takes place. Vitamin A absorption requires bile salts, pancreatic lipase, and dietary fat. It is transported in the blood to the liver by the chylomicron fraction of the lymph. Vitamin A is stored in Kupffer cells of the liver mainly as the palmitate. Normal serum vitamin A is 80–300 Units per 100 mL (plasma range is 30–70 mcg per dl) and for carotenoids 270–753 Units per 100 mL. The normal adult liver contains approximately 100 to 300 micrograms per gram, mostly as retinol palmitate.

1949

ARYNTA

lisdexamfetamine dimesylate

Launch

ORAL · SOLUTION

dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known.

(): Attention Deficit Hyperactivity Disorder (ADHD) in adultsolder () Lisdexamfetamine dimesylate capsules are not indicated for weight loss

INTRAVENOUS · INJECTABLE

L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of ASPARLAS is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine, and therefore depend on an exogenous source of asparagine for survival.

12.1 Mechanism of Action Atovaquone is a quinone antimicrobial drug [ see Microbiology ] . 12.2 Pharmacodynamics Relationship between Plasma Atovaquone Concentrations and Clinical Outcome In a comparative clinical trial, HIV/AIDS subjects received atovaquone tablets 750 mg 3 times daily or TMP-SMX for treatment of mild-to-moderate PCP for 21 days [see Clinical Studies ()] ; the relationship between atovaquone plasma concentrations and successful treatment outcome from 113 of these subjects for whom both steady-state drug concentrations and outcome data were available is shown in Table 6. Table 6. Relationship between Plasma Atovaquone Concentrations and Successful Treatment Outcome Steady-State Plasma Atovaquone Concentrations (mcg/mL) Successful Treatment No. of Successes/No. in Group (%) 0 to <5 0/6 (0%) 5 to <10 18/26 (69%) 10 to <15 30/38 (79%) 15 to <20 18/19 (95%) ≥20 24/24 (100%) Successful treatment outcome was defined as improvement in clinical and respiratory measures persisting at least 4 weeks after cessation of therapy. Improvement in clinical and respiratory measures was assessed using a composite of parameters that included oral body temperature, respiratory rate, and severity scores for cough, dyspnea, and chest pain/tightness. Cardiac Effects The effect of atovaquone oral suspension on the QT interval is unknown in humans. 12.3 Pharmacokinetics Plasma atovaquone concentrations do not increase proportionally with dose following ascending repeat-dose administration of atovaquone oral suspension in healthy subjects. When atovaquone oral suspension was administered with food at dosage regimens of 500 mg once daily, 750 mg once daily, and 1,000 mg once daily, mean (±SD) steady-state plasma atovaquone concentrations were 11.7 ± 4.8, 12.5 ± 5.8, and 13.5 ± 5.1 mcg/mL, respectively. The corresponding mean (±SD) C max concentrations were 15.1 ± 6.1, 15.3 ± 7.6, and 16.8 ± 6.4 mcg/mL. Absorption Atovaquone is a highly lipophilic compound with low aqueous solubility. The mean (±SD) absolute bioavailability of atovaquone from a 750-mg dose of atovaquone oral suspension administered under fed conditions in 9 HIV-1-infected (CD4 >100 cells/mm) volunteers was 47% ± 15%. Effect of Food: Administering atovaquone oral suspension with food enhances atovaquone bioavailability. Sixteen healthy subjects received a single 750-mg dose of atovaquone oral suspension after an overnight fast and following a meal (23 g fat: 610 kCal). The mean (±SD) atovaquone AUC under fasting and fed conditions were 324 ± 115 and 801 ± 320 h•mcg/mL, respectively, representing a 2.6 ± 1.0-fold increase. Distribution Following IV administration of atovaquone, the mean (±SD) volume of distribution at steady state (Vd ss ) was 0.60 ± 0.17 L/kg (n = 9). Atovaquone is extensively bound to plasma proteins (99.9%) over the concentration range of 1 to 90 mcg/mL. In 3 HIV-1-infected children who received 750 mg atovaquone as the tablet formulation 4 times daily for 2 weeks, the cere

Pneumocystis jirovecii pneumonia (PCP) in adultsadolescents (aged 13 yearsolder)

2021

AVELOX

moxifloxacin hydrochloride

LOE Approaching

Oral · Tablet

[see Clinical Pharmacology ()].

Administration ()Use In Specific Populations ()]Acute Bacterial Sinusitis caused by Streptococcus pneumoniae+21 more

2001

AZMIRO

testosterone cypionate

Peak

INTRAMUSCULAR · SOLUTION

androgens, including testosterone and dihydrotestosterone (DHT), are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect.

severe hypoglycemia in adultsolder with diabetes

2019

BIDIL

hydralazine hydrochloride and isosorbide dinitrate

LOE Approaching

ORAL · TABLET

established. Isosorbide dinitrate is a vasodilator affecting both arteries and veins. Its dilator properties result from the release of nitric oxide and the subsequent activation of guanylyl cyclase, and ultimate relaxation of vascular smooth muscle. Several well-controlled clinical trials have used exercise testing to assess the anti-anginal efficacy of chronically-delivered nitrates. In the large majority of these trials, active agents were no more effective than placebo after 24 hours (or less) of continuous therapy. Attempts to overcome nitrate tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours is response to nitrates restored. Hydralazine hydrochloride is a selective dilator of arterial smooth muscle. Animal data suggests that hydralazine may also mitigate tolerance to nitrates.

heart failureto prolong time to hospitalization for heart failureto improve patient-reported functional status

2005

BRYNOVIN

sitagliptin hydrochloride oral

Growth

ORAL · SOLUTION

Dipeptidyl Peptidase 4 Inhibitors

type 2 diabetes mellitus

2025

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Interview Prep Quick Facts

Founded: 2014

Portfolio: 496 approved products

Top TAs: Cardiovascular, Neurology, Infectious Diseases

H-1B (2023): 1 approval

Portfolio Health

Pre-Launch151 (30%)

Launch4 (1%)

Growth8 (2%)

Peak36 (7%)

LOE Approaching70 (14%)

Post-LOE227 (46%)

496 total products

Therapeutic Area Focus

38 marketed

34 marketed

23 marketed

14 marketed

9 marketed

7 marketed

6 marketed

5 marketed

Marketed

Pipeline

Visa Sponsorship

Sponsors Work Visas

H-1B Petitions (FY2023)

Approved

Denied

100%

Rate

Source: USCIS H-1B Employer Data Hub