Drug Approval | October 03, 2022
Lupin gets EIR from USFDA for its Ankleshwar facility
The inspection of the facility was conducted from August 16-19, 2022.
The inspection of the facility was conducted from August 16-19, 2022.
Department and Industry Associations to organize 3 days National Level Expo on Indian Medical Devices Sector at Pragati Maidan, New Delhi between 9-11 Dec 2022, first of its kind expo in India
Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
The company will address the observations within a stipulated timeline working with the regulators
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
In the next six months, the program aims to screen 4,000 women from underprivileged communities in and around Mathura
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
Transformation to pure-play Innovative Medicines company nears completion
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