Lupin receives tentative approval from USFDA for Dolutegravir and Rilpivirine Tablets
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
This FDC has been launched under the brand name Zita-PioMet, and contains Teneligliptin (20 mg) + Pioglitazone (15 mg) + Metformin (500mg/1000mg) in a sustained release (SR) formulation
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD
Through lifestyle modifications, ADORE will assess the progress of patients based on parameters like reduction in blood sugar levels and weight, among others
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
India is home to nearly 80 million diabetics and this number is expected to rise to a staggering 134 million in the next 25 years.
Within the API segment, ~20% of the revenues came from the domestic market and ~80% from the exports market
Formulation revenue decreased by 7.6% YoY to Rs. 4,770 crore whereas in Q2 FY23, API business posted a growth of 24.2% YoY with revenue of Rs. 969.4 crore
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
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