Drug Approval | September 09, 2024
Granules India’s Gagillapur facility completes USFDA inspection with six observations
The recent inspection covered both cGMP and PAI processes
The recent inspection covered both cGMP and PAI processes
Phase 3 study results will form the basis for future discussions with global regulatory authorities
The new Injectable Facility housed in Akums Healthcare started commercial production on 22nd August 2024, with a capacity of 362 million units annually
Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older
Higher revenues backed by huge demand and expanding network contributed to the growth in bottom line
In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
Revenue up 16.3% to Rs 5,600 crore versus Rs 4,814 crore
Our centers are performing as expected or even better
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