Drug Approval | November 11, 2024
Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules
Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension
Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension
The program aims to accelerate the development of 6 Indian innovations to improve ease of access to diagnostics and treatment monitoring
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Q2 FY25 Total Income was at Rs. 85.4 crore
This product will be manufactured at Lupin’s Nagpur facility in India
Revenue from operations registered a growth of 12% Y-o-Y at Rs 337.63 crores for H1 FY25
The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities
Revenue share from the North America increased to 79% in Q2 FY25 as compared to 67% in Q2 FY24
Revenue at Rs 3,623 crore, EBITDA at Rs 718 crore
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
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