News | February 18, 2023
Lupin receives EIR from USFDA for injectable facility in Nagpur
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
With the new facility, the company underlines its commitment to meet the substantially growing demand for its MCC
Themis will market this drug with the brand name REMITHEM.
Durvalumab in combination with chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer
The company's consolidated revenues for the quarter grew 36% to Rs. 3,020 crore on the back of robust performance across all its three businesses
The company has launched its new range of 25 allopathy ophthalmic products including GUERIMOD, GUERIPRED, BIMATO MST etc. for curing various diseases related to eyes
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
The investment enhances Lonza’s capabilities and flexibility to support both clinical and commercial supply and will play a key role in meeting the growing market demand for bioconjugates
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