GP
Gland Pharma
India - Hyderabad
PharmaceuticalFocus: Small volume parenterals
Gland Pharma is a life sciences company focused on Small volume parenterals.
Neurology
Funding Stage
PUBLIC
Open Jobs
0
Products & Portfolio (50)
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 up to 3,000 mg and repeated doses of 1,000 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 Injection has been demonstrated to be dose proportional in adults following administration of single doses of 500, 650, and 1,000 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 ½ ], 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 1,000 mg in adults are summarized in . Table 5. Acetaminophen Injection Pharmacokinetic Parameters Subpopulations Mean (SD) AUC 0-6h (mcg×h/mL) C max (mcg /mL) T ½ (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 1,000 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. Elimination Metabolism 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 and merc
mild to moderate pain in adultolder () Management of moderate to severe pain with adjunctive opioid analgesics in adultolder () Reduction of fever in adult
2025
30
ACETAZOLAMIDE SODIUM
acetazolamide sodium
Post-LOE
INJECTION · INJECTABLE
CLINICAL PHARMACOLOGY Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (e.g., some types of glaucoma), in the treatment of certain convulsive disorders (e.g., epilepsy) and in the promotion of diuresis in instances of abnormal fluid retention (e.g., cardiac edema). Acetazolamide is not a mercurial diuretic. Rather, it is a nonbacteriostatic sulfonamide possessing a chemical structure and pharmacological activity distinctly different from the bacteriostatic sulfonamides. Acetazolamide is an enzyme inhibitor that acts specifically on carbonic anhydrase, the enzyme that catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In the eye, this inhibitory action of acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in cases of glaucoma and even in certain nonglaucomatous conditions. Evidence seems to indicate that acetazolamide has utility as an adjuvant in the treatment of certain dysfunctions of the central nervous system (e.g., epilepsy). Inhibition of carbonic anhydrase in this area appears to retard abnormal, paroxysmal, excessive discharge from central nervous system neurons. The diuretic effect of acetazolamide is due to its action in the kidney on the reversible reaction involving hydration of carbon dioxide and dehydration of carbonic acid. The result is renal loss of HCO 3 ion, which carries out sodium, water, and potassium. Alkalinization of the urine and promotion of diuresis are thus affected. Alteration in ammonia metabolism occurs due to increased reabsorption of ammonia by the renal tubules as a result of urinary alkalinization.
heart failureglaucoma
2025
30
ADENOSINE
adenosine
Post-LOE
INJECTION · INJECTABLE
Adenosine Receptor Agonists
atrial fibrillation
2007
30
ADENOSINE
adenosine
Post-LOE
INJECTION · INJECTABLE
Adenosine Receptor Agonists
atrial fibrillation
2018
30
ALCAFTADINE
alcaftadine
Post-LOE
OPHTHALMIC · SOLUTION/DROPS
Histamine H1 Receptor Antagonists
itchy eyes due to pollenragweedgrass+2 more
2024
30
ALLOPURINOL SODIUM
allopurinol
Post-LOE
INJECTION · INJECTABLE
base, hypoxanthine. Allopurinol and its oxypurinol metabolite inhibitor xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and of xanthine to uric acid, the end product of purine metabolism in humans. Allopurinol does not disrupt the biosynthesis of purines. The action of oral allopurinol differs from that of uricosuric agents, which lower the serum uric acid level by increasing urinary excretion of uric acid. Allopurinol reduces both the serum and urinary uric acid levels by inhibiting the formation of uric acid. The use of allopurinol to block the formation of urates avoids the hazard of increased renal excretion of uric acid posed by uricosuric drugs.
lymphomasolid tumor malignanciesurinary uric acid levels+1 more
2022
30
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
Post-LOE
INJECTION · INJECTABLE
drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. Like class I drugs, amiodarone blocks sodium channels at rapid pacing frequencies, and like class II drugs, amiodarone exerts a noncompetitive antisympathetic action. One of its main effects, with prolonged administration, is to lengthen the cardiac action potential, a class III effect. The negative chronotropic effect of amiodarone in nodal tissues is similar to the effect of class IV drugs. In addition to blocking sodium channels, amiodarone blocks myocardial potassium channels, which contributes to slowing of conduction and prolongation of refractoriness. The antisympathetic action and the block of calcium and potassium channels are responsible for the negative dromotropic effects on the sinus node and for the slowing of conduction and prolongation of refractoriness in the atrioventricular (AV) node. Its vasodilatory action can decrease cardiac workload and consequently myocardial oxygen consumption. Intravenous amiodarone administration prolongs intranodal conduction (Atrial-His, AH) and refractoriness of the atrioventricular node (ERP AVN), but has little or no effect on sinus cycle length (SCL), refractoriness of the right atrium and right ventricle (ERP RA and ERP RV), repolarization (QTc), intraventricular conduction (QRS), and infra-nodal conduction (His-ventricular, HV). A comparison of the electrophysiologic effects of intravenous amiodarone and oral amiodarone is shown in the table below. TABLE 6: EFFECTS OF INTRAVENOUS AND ORAL AMIODARONE ON ELECTROPHYSIOLOGIC PARAMETERS Formulation SCL QRS QTc AH HV ERP ERP ERP RA RV AVN Intravenous ↔ ↔ ↔ ↑ ↔ ↔ ↔ ↑ Oral ↑ ↔ ↑ ↑ ↔ ↑ ↑ ↑ ↔ No change At higher doses (>10 mg/kg) of intravenous amiodarone, prolongation of the ERP RV and modest prolongation of the QRS have been seen. These differences between oral and IV administration suggest that the initial acute effects of intravenous amiodarone may be predominately focused on the AV node, causing an intranodal conduction delay and increased nodal refractoriness due to slow channel blockade (class IV activity) and noncompetitive adrenergic antagonism (class II activity).
2005
30
ANGIOTENSIN ll ACETATE
angiotensin ii
Post-LOE
INTRAVENOUS · SOLUTION
release. Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein coupled-angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca /calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.
2025
30
ARGATROBAN
argatroban
Post-LOE
INJECTION · INJECTABLE
Thrombin Inhibitors
For prophylaxis or treatment of thrombosis
2023
30
ARGATROBAN IN SODIUM CHLORIDE
argatroban
Post-LOE
INTRAVENOUS · INJECTABLE
Thrombin Inhibitors
For prophylaxis or treatment of thrombosis
2017
30
ARSENIC TRIOXIDE
arsenic trioxide
Post-LOE
INJECTION · INJECTABLE
understood. Arsenic trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukemia (PML)-retinoic acid receptor (RAR)-alpha.
For induction of remission and consolidation
2021
30
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride
Post-LOE
OPHTHALMIC · SOLUTION/DROPS
CLINICAL PHARMACOLOGY Azelastine hydrochloride is a relatively selective histamine H 1 antagonist and an inhibitor of the release of histamine and other mediators from cells (e.g. mast cells) involved in the allergic response. Based on in-vitro studies using human cell lines, inhibition of other mediators involved in allergic reactions (e.g. leukotrienes and PAF) has been demonstrated with azelastine hydrochloride. Decreased chemotaxis and activation of eosinophils has also been demonstrated. Pharmacokinetics and Metabolism Absorption of azelastine following ocular administration was relatively low. A study in symptomatic patients receiving one drop of azelastine hydrochloride ophthalmic solution in each eye two to four times a day (0.06 to 0.12 mg azelastine hydrochloride) demonstrated plasma concentrations of azelastine hydrochloride to generally be between 0.02 and 0.25 ng/mL after 56 days of treatment. Three of nineteen patients had quantifiable amounts of N-desmethylazelastine that ranged from 0.25 to 0.87 ng/mL at Day 56. Based on intravenous and oral administration, the elimination half-life, steady-state volume of distribution and plasma clearance were 22 hours, 14.5 L/kg and 0.5 L/h/kg, respectively. Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine. Azelastine hydrochloride is oxidatively metabolized to the principal metabolite, N-desmethylazelastine, by the cytochrome P450 enzyme system. In-vitro studies in human plasma indicate that the plasma protein binding of azelastine and N-desmethylazelastine are approximately 88% and 97%, respectively. Clinical Trials In a conjunctival antigen challenge study, azelastine hydrochloride ophthalmic solution was more effective than its vehicle in preventing itching associated with allergic conjunctivitis. Azelastine hydrochloride ophthalmic solution had a rapid (within 3 minutes) onset of effect and a duration of effect of approximately 8 hours for the prevention of itching. In environmental studies, adult and pediatric patients with seasonal allergic conjunctivitis were treated with azelastine hydrochloride ophthalmic solution for two to eight weeks. In these studies, azelastine hydrochloride ophthalmic solution was more effective than its vehicle in relieving itching associated with allergic conjunctivitis.
itching of the eye associated with allergic conjunctivitis
2020
30
Open Jobs (0)
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Interview Prep Quick Facts
Portfolio: 161 approved products
Top TAs: Oncology, Cardiovascular, Infectious Diseases
Portfolio Health
Pre-Launch3 (2%)
Post-LOE157 (98%)
161 total products
Therapeutic Area Focus
Oncology
29 marketed
Cardiovascular
23 marketed
Infectious Diseases
10 marketed
Neurology
10 marketed
Hematology
9 marketed
Ophthalmology
8 marketed
Respiratory
5 marketed
Endocrinology
4 marketed
Marketed
Pipeline