Shilpa Medicare Hyderabad facility receives US FDA clearance

The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties

Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets

The ANDA was filed as 'First to File' submission on NCE-1 date.

Shilpa Medicare completes clinical studies of high concentration biosimilar Adalimumab

The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets

ShilpaMedicare Q1FY23 consolidated PAT drops to to Rs. 84.85 lakhs

Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review

The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing

Shilpa Medicare’s Unit VI, Bengaluru facility has been issued UK MHRA GMP

The GMP facility is equipped with state of art machinery for the needs of Global commercial requirements

USFDA concludes inspection of Shilpa Medicare with four observations

The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory

Shilpa Medicare receives NoC for biosimilar Aflibercept

Aflibercept is the second biosimilar product that has entered the clinical trial phase after biosimilar Adalimumab

Mylab partners with Shilpa Biologicals for vaccines and therapeutics segment

Shilpa Biologicals has tie-ups with Zydus to supply ZyCoV-D vaccine drug substance and Dr Reddy’s to make Sputnik V from its facility in Dharwad

Shilpa Medicare launch Prucalshil for treatment of constipation

Prucalopride medicine in the form of Orally Disintegrating Strips are most convenient dosage form for geriatric patients