Drug Approval | January 19, 2023
USFDA completes inspection at APL HealthCare
The company has been issued ‘Form 483’ with two observations
The company has been issued ‘Form 483’ with two observations
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
Valentas and Arnipin are indicated to reduce repeated hospitalization and the risk of cardiovascular death among adult patients with chronic mild to moderate heart failure
Sacu V is priced at Rs. 19 per tablet for a dose of 50 mg (sacubitril 24 mg + valsartan 26 mg)
The divested brands include Onabet, Halovate, Sorvate, Luligee, Demelan, Aceret, Dosetil, Revize, and Powercort, and their sub-brands
AI-based medical imaging equipment firm Lunit has signed a contract to supply AI-based breast cancer screening solution “Lunit Insight MMG”
This DSIR recognition for company's in-house R&D Unit make it eligible for receiving funds for R&D purpose from various government departments and agencies
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)
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company will respond to these observations within the stipulated time period.
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