
UB461
ProductLincomycin Injection
Strength600mg/2ml, 3g/10ml
IndicationsGram-positive bacterial infection; Anaerobic bacterial infection
TherapeuticsInfectious Diseases
GMPUS - FDA
RegistrationUnited States
ModalitiesSmall Molecule
Exclusive Summary
- - Patent long expired and US registration completed, enabling rapid distribution via reliance pathways across multiple markets.
- - Two standard 300 mg/mL strengths cover routine and high-dose inpatient needs, simplifying hospital procurement and tenders.
- - Addresses the non–beta-lactam need in patients with reported penicillin allergy (about 8–10% globally) requiring anaerobic/Gram-positive coverage.
- - Mature generic with broad global supply; typically 40–80% cheaper than originator, delivering clear cost advantage in price-sensitive markets.
- - US compliance and registration enhance buyer confidence and facilitate entry into reliance/regulatory-reference markets in LATAM/MENA/SSA.
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