Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
The company is committed to address this observation comprehensively within stipulated time
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
With this, for all our USFDA facilities, EIRs are in place
Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
The USFDA has issued 5 observations pursuant to the completion of audit
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
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