Lupin receives approval from FDA for Cyanocobalamin Nasal Spray
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
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
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
The product will be produced at the Eugia Pharma Specialities, Unit-I, Medchal, Malkajgiri District, Telangana, India
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