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
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
A well researched and affordable fixed dose combination, which will significantly improve the glycemic control in adult patients suffering from uncontrolled Type 2 diabetes, especially the ones with comorbidities
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
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