Baxter

Costa Rica - Cartago

Biotechnology6 H-1B visas (FY2023)

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Focus: Medication Delivery

Baxter is a life sciences company focused on Medication Delivery.

OncologyCardiovascularInfectious DiseasesMetabolic DiseasesNeurology

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Products & Portfolio (25)

25 discontinued products not shown

ACETAMINOPHEN

acetaminophen

Post-LOE

INTRAVENOUS · SOLUTION

12.1 Mechanism of Action The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions. 12.2 Pharmacodynamics Acetaminophen has been shown to have analgesic and antipyretic activities in animal and human studies. Single doses of acetaminophen injection up to 3000 mg and repeated doses of 1000 mg every 6 hours for 48 hours have not been shown to cause a significant effect on platelet aggregation. Acetaminophen does not have any immediate or delayed effects on small-vessel hemostasis. Clinical studies of both healthy subjects and patients with hemophilia showed no significant changes in bleeding time after receiving multiple doses of oral acetaminophen. 12.3 Pharmacokinetics Distribution The pharmacokinetics of acetaminophen injection have been studied in patients and healthy subjects up to 60 years old. The pharmacokinetic profile of acetaminophen has been demonstrated to be dose proportional in adults following administration of single doses of 500, 650, and 1000 mg. The maximum concentration (C max ) occurs at the end of the 15-minute intravenous infusion of acetaminophen injection. Compared to the same dose of oral acetaminophen, the C max following administration of acetaminophen injection is up to 70% higher, while overall exposure (area under the concentration time curve [AUC]) is very similar. Pharmacokinetic parameters of acetaminophen injection (AUC, C max , terminal elimination half-life [T 1/2 ], systemic clearance [CL], and volume of distribution at steady-state [Vss]) following administration of a single intravenous dose of 15 mg/kg in children and adolescents and 1000 mg in adults are summarized in Table 5. Table 5. Acetaminophen Injection Pharmacokinetic Parameters Subpopulations Mean (SD) AUC 0-6h (mcg × h/mL) C max (mcg/mL) T 1/2 (h) CL (L/h/kg) Vss (L/kg) Children 38 (8) 29 (7) 3.0 (1.5) 0.34 (0.10) 1.2 (0.3) Adolescents 41 (7) 31 (9) 2.9 (0.7) 0.29 (0.08) 1.1 (0.3) Adults 43 (11) 28 (21) 2.4 (0.6) 0.27 (0.08) 0.8 (0.2) The concentrations of acetaminophen observed in neonates greater than 32 weeks gestational age at birth treated with 12.5 mg/kg dose are similar to infants, children and adolescents treated with a 15 mg/kg dose, and similar to adults treated with a 1000 mg dose. At therapeutic levels, binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%). Acetaminophen appears to be widely distributed throughout most body tissues except fat. Metabolism and Excretion Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: Conjugation with glucuronide, conjugation with sulfate, and oxidation via the cytochrome P450 enzyme pathway, primarily CYP2E1, to form a reactive intermediate metabolite (N-acetyl-p-benzoquinone imine or NAPQI). With therapeutic doses, NAPQI undergoes rapid conjugation with glutathione and is then further metabolized to form cysteine

mild to moderate pain in adultoldermoderate to severe pain with adjunctive opioid analgesics in adult+1 more

2021

ACETIC ACID 0.25% IN PLASTIC CONTAINER

acetic acid

LOE Approaching

IRRIGATION, URETHRAL · SOLUTION

CLINICAL PHARMACOLOGY The minimal amount of acetic acid which may enter the systemic circulation is readily metabolized.

1982

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER

glycine

LOE Approaching

IRRIGATION · SOLUTION

CLINICAL PHARMACOLOGY 1.5% Glycine Irrigation, USP is useful as an irrigating solution for the urinary bladder because this solution is nonhemolytic, nonelectrolytic or very weakly ionized, and provides a high degree of visibility for urologic procedures requiring endoscopy. During transurethral surgical procedures, the solution acts as a lavage for removing blood and tissue fragments. It also maintains the patency of an indwelling catheter in the immediate postoperative period. Glycine which enters the systemic circulation is converted to serine and glyoxylic acid.

INJECTION · INJECTABLE

site. Argatroban does not require the co-factor antithrombin III for antithrombotic activity. Argatroban exerts its anticoagulant effects by inhibiting thrombin-catalyzed or -induced reactions, including fibrin formation; activation of coagulation factors V, VIII, and XIII; activation of protein C; and platelet aggregation. Argatroban inhibits thrombin with an inhibition constant (Ki) of 0.04 µM. At therapeutic concentrations, argatroban has little or no effect on related serine proteases (trypsin, factor Xa, plasmin, and kallikrein). Argatroban is capable of inhibiting the action of both free and clot-associated thrombin.

For prophylaxis or treatment of thrombosis

BACTOCILL IN PLASTIC CONTAINER

oxacillin

LOE Approaching

INJECTION · INJECTABLE

Mechanism of Action Penicillinase-resistant penicillins exert a bactericidal action against penicillin susceptible microorganisms during the state of active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall.

the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug

1989

BENDAMUSTINE HYDROCHLORIDE

bendamustine hydrochloride

Peak

INTRAVENOUS · SOLUTION

purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways. Bendamustine is active against both quiescent and dividing cells. The exact mechanism of action of bendamustine remains unknown.

within six months of treatment with rituximaba rituximab-containing regimenleukemia+1 more

2022

BREVIBLOC

esmolol hydrochloride

LOE Approaching

INJECTION · INJECTABLE

(Esmolol Hydrochloride) injection is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent with rapid onset, a very short duration of action, and no significant intrinsic sympathomimetic or membrane stabilizing activity at therapeutic dosages. Its elimination half-life after intravenous infusion is approximately 9 minutes. BREVIBLOC injection inhibits the beta 1 receptors located chiefly in cardiac muscle, but this preferential effect is not absolute and at higher doses it begins to inhibit beta 2 receptors located chiefly in the bronchial and vascular musculature.

noncompensatory sinus tachycardia wherethe physician's judgmentthe rapid heart rate requires specific intervention+3 more

1986

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

esmolol hydrochloride

LOE Approaching

INJECTION · INJECTABLE

noncompensatory sinus tachycardia wherethe physician's judgmentthe rapid heart rate requires specific intervention+3 more

1986

BREVIBLOC IN PLASTIC CONTAINER

esmolol hydrochloride

LOE Approaching

INJECTION · INJECTABLE

noncompensatory sinus tachycardia wherethe physician's judgmentthe rapid heart rate requires specific intervention+3 more

1986

CARDIOPLEGIC IN PLASTIC CONTAINER

calcium chloride, magnesium chloride, potassium chloride and sodium chloride

Post-LOE

PERFUSION, CARDIAC · SOLUTION

CLINICAL PHARMACOLOGY Cardioplegic Solution with added sodium bicarbonate when cooled and instilled into the coronary artery vasculature, causes prompt arrest of cardiac electromechanical activity, combats intracellular ion losses and buffers ischemic acidosis. When used with hypothermia and ischemia, the action may be characterized as cold ischemic potassium-induced cardioplegia. This is conducive to providing the surgeon with a quiet, relaxed heart and bloodless field of operation. Calcium (Ca) ion in low concentration is included in the solution to maintain integrity of cell membrane to ensure that there is no likelihood of calcium paradox during reperfusion. Magnesium (Mg) ion may help stabilize the myocardial membrane by inhibiting a myosin phosphorylase, which protects adenosine triphosphate (ATP) reserves for postischemic activity. The protective effects of magnesium and potassium have been shown to be additive. Potassium (K) ion concentration is responsible for prompt cessation of mechanical myocardial contractile activity. The immediacy of the arrest thus preserves energy supplies for postischemic contractile activity in diastole. The chloride (Cl) and sodium (Na) ions have no specific role in the production of cardiac arrest. Sodium is essential to maintain ionic integrity of myocardial tissue. The chloride ions are present to maintain the electroneutrality of the solution. Added bicarbonate (HCO 3 ) anion is included as a buffer to render the solution slightly alkaline and compensate for the metabolic acidosis that accompanies ischemia. Extemporaneous alternative buffering to the described formulation of this solution is not recommended.

2000

CEFAZOLIN IN DEXTROSE

cefazolin sodium

Peak

INTRAVENOUS · SOLUTION

12.1 Mechanism of Action Cefazolin is an antibacterial drug [ see ]. 12.2 Pharmacodynamics The pharmacokinetic/pharmacodynamic relationship for cefazolin has not been evaluated in patients. 12.3 Pharmacokinetics Studies have shown that following intravenous administration of cefazolin to normal subjects, mean serum concentrations peaked at approximately 185 mcg/mL and were approximately 4 mcg/mL at 8 hours for a 1 gram dose. The serum half-life for cefazolin is approximately 1.8 hours following IV administration. In a study of constant intravenous infusion with dosages of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours (approximately 100 mg), cefazolin serum concentrations at the third hour of approximately 28 mcg/mL. Plasma pharmacokinetic parameters of cefazolin in healthy adult subjects (N=12) following a single 15- minute IV infusion of 2 grams of cefazolin for injection and dextrose injection are summarized in . Table 7: Mean (Standard Deviation) Plasma Pharmacokinetic Parameters of Cefazolin in Healthy Adult Subjects N C max (mcg/mL) T max T max reported as median (range) (h) AUC 0-inf (mcg*h/mL) T 1/2 (h) CL (L/h) V z (L) Single 2 grams Dose as a 15- Minute IV Infusion 12 280.9 (45.9) 0.25 (0.25-0.33) 509.9 (89.3) 2.01 (0.28) 4.03 (0.68) 11.50 (1.53) N= number of subjects observed; C max = maximum plasma concentration; T max = time to maximum plasma concentration; AUC 0-inf = area under the plasma concentration-time curve extrapolated to infinity; t 1/2 = apparent plasma terminal elimination half-life; CL = total clearance; V z = volume of distribution Plasma pharmacokinetic parameters of cefazolin in healthy adult subjects with a weight of greater than or equal to 120 kg (N=12) following a single 30-minute IV infusion of 3 grams of Cefazolin in Dextrose Injection are summarized in Table 8. Table 8: Mean (Standard Deviation) Plasma Pharmacokinetic Parameters of Cefazolin in Healthy Adult Subjects ≥ 120 kg N C max (mcg/mL) T max T max reported as median (range) (h) AUC 0-inf (mcg*h/mL) T 1/2 (h) CL (L/h) V z (L) Single 3 grams Dose as a 30-Minute IV Infusion 12 223 (26.0) 0.55 (0.54-1.26) 585 (76.5) 2.29 (0.28) 5.20 (0.67) 17.0 (1.54) N= number of subjects observed; C max = maximum plasma concentration; T max = time to maximum plasma concentration; AUC 0-inf = area under the plasma concentration-time curve extrapolated to infinity; t 1/2 = apparent plasma terminal elimination half-life; CL = total clearance; V z = volume of distribution Studies in patients hospitalized with infections indicate that cefazolin produces mean peak serum concentrations approximately equivalent to those seen in healthy subjects. Bile concentrations in patients without obstructive biliary disease can reach or exceed serum concentrations by up to five times; however, in patients with obstructive biliary disease, bile concentrations of cefazolin are considerably lower than serum concentrations (less than 1.0 mcg/mL). In synovial fluid, the

respiratory tract infections due to Streptococcus pneumoniaeStaphylococcus aureusStreptococcus pyogenes in adults+14 more

2015

CEFEPIME IN PLASTIC CONTAINER

cefepime

LOE Approaching

INJECTION · INJECTABLE

drug. [See ]

2008

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Interview Prep Quick Facts

Portfolio: 345 approved products

Top TAs: Metabolic Diseases, Oncology, Infectious Diseases

H-1B (2023): 6 approvals

Portfolio Health

Pre-Launch13 (4%)

Growth5 (1%)

Peak11 (3%)

LOE Approaching216 (63%)

Post-LOE100 (29%)

345 total products

Therapeutic Area Focus

34 marketed

17 marketed

15 marketed

14 marketed

11 marketed

11 marketed

2 marketed

2 marketed

Marketed

Pipeline

Visa Sponsorship

Sponsors Work Visas

H-1B Petitions (FY2023)

Approved

Denied

86%

Rate

Source: USCIS H-1B Employer Data Hub