USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

Hutchmed completes rolling submission of NDA to USFDA for fruquintinib

NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China

Eugia Pharma receives USFDA approval for Lenalidomide Capsules

The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone

Orchid Pharma launches Rs. 500 Cr QIP programme

With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023

Aurobindo Pharma Q2 FY23 revenue down 3.4%

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

Japan homegrown COVID-19 mRNA vaccine needs superior safety and efficacy data for success, says GlobalData

The booster vaccination trial is still ongoing and further data will provide more information around safety and efficacy.

Lupin and I'rom signs licensing agreement for Denosumab biosimilar for Japan

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients

Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension

The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA

Piramal Pharma expands API capabilities at Digwal

Site has a capital investment program of ~$30 million spent or committed over the last three years to expand capabilities and improve operational efficiencies