Lupin receives tentative approval from USFDA for Dolutegravir Tablets for oral suspension
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
Pratima takes on the role of Country Speaker in addition to her role as GM and MD of Merck Specialties in India
Dr. Vivek joins Healthium after a stint at Ethicon, Johnson & Johnson
The detailed terms in relation to the Rights Issue, including but not limited to the issue price, rights entitlement ratio, record date, timing and terms of payment will be determined in due course.
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
The positive safety review from the DSMB enables the trial to move forward as planned, with an estimated completion date in December 2023
The €70 million investment will allow the large-scale manufacturing of high-purity reagents for quality control and testing for biopharma customers, increasing annual output by several thousand tons
The company is already marketing the 4 mg and 10 mg strengths
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