Lupin Gets USFDA Approval for Generic Amifampridine Tablets
Lupin has won USFDA approval for generic amifampridine 10 mg tablets to treat Lambert-Eaton myasthenic syndrome, with 180-day shared generic exclusivity.
Pharma
Court Discharges Ex-Drug Controller Eswara Reddy in Bribery Case
A CBI court in Delhi discharged ex-joint drugs controller S Eswara Reddy and three others in the 2022 Biocon Biologics bribery case, citing no evidence.
Emcure Q2 FY27 Profit Rises 29% as Overseas Sales Jump 35%
Emcure Pharmaceuticals Q2 FY27 profit rose 29.3% to ₹325.1 crore as revenue grew 24.3% to ₹2,820.5 crore, led by 34.5% growth in international sales.
AstraZeneca Gets Delhi HC Relief in ₹151 Crore NPPA Inhaler Case
Delhi High Court bars NPPA from coercive steps against AstraZeneca Pharma India over ₹151 crore Symbicort inhaler overcharging claim until 11 January 2027.
Gland Pharma Wins USFDA Nod for Generic Depo-Medrol Injection
Gland Pharma wins USFDA approval for generic Methylprednisolone Acetate Injectable Suspension, equal to Pfizer’s Depo-Medrol, a USD 214 million US market.
Dr Reddy’s Gets USFDA Tentative Nod for Generic Lenacapavir
Dr Reddy’s wins USFDA tentative approval under PEPFAR for generic twice-yearly lenacapavir for HIV prevention, with first supplies due before end-2026.
Akums Q2 FY27 Profit Jumps 168% as CDMO Revenue Rises 39%
Akums Q2 FY27 profit rose 168% to ₹115 crore as revenue grew 31.9% to ₹1,342 crore and its CDMO business, now 83% of sales, grew 38.6%.
Wockhardt Widens Miqnaf Access as Q2 Revenue Rises 24%
Wockhardt Miqnaf access widens after DCGI lifted a supply condition on the novel antibiotic, as Q2 FY27 revenue rose 24% to ₹969 crore on biotech growth.
Alkem’s Mandva API Plant Clears USFDA Audit With Zero 483s
Alkem Laboratories’ Mandva API facility cleared a five-day USFDA inspection (26–30 October 2026) with no Form 483 observations, a cleaner result than the site’s 2023 audit.
OneSource Bengaluru Sterile Plant Gets USFDA VAI Status
OneSource Specialty Pharma has received a USFDA EIR with VAI classification for its Bengaluru Sterile Product Division, closing the June 2026 inspection.
Omron Starts Blood Pressure Monitor Production in Chennai
Omron Healthcare has begun full-scale blood pressure monitor production at its first India factory near Chennai, aiming for 3 million units a year by 2028.
Sun Pharma Wins CDSCO Nod for Generic Oral Semaglutide Pill
Sun Pharmaceutical Industries has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market a generic […]
Zydus Completes ₹84 Crore Buy of Sterling Biotech’s API Business
Zydus Lifesciences has closed its ₹84 crore purchase of Sterling Biotech’s API business, adding fermentation-based APIs and a plant near Vadodara.
