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)
Cipla has a robust governance model focused on sustainability
With this, the number of marketing approvals for its oncology products across 75 countries has gone up to 503
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
The identified products for Active Pharmaceutical Ingredients (API) will be developed under the CRAMS and CDMO models
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
The positive safety review from the DSMB enables the trial to move forward as planned, with an estimated completion date in December 2023
Lupin has received US$ 25 million from AbbVie for initiation of Phase 1 clinical studies successfully
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