Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Dr. Reddy's Laboratories has reported total income of Rs. 7,672.7 crores during the period ended June 30, 2024
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
Reported profit after tax declined 19% year-on-year to Rs 76 crores
The inspections concluded with no Form 483 observations or significant critical findings
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
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