Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy

Azenta obtains regulatory approval for clinical long-read whole genome sequencing test

Performed within GENEWIZ from Azenta Life Sciences' CLIA-certified and CAP-accredited state-of-the-art clinical genomics laboratory

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules

The product will be manufactured at Lupin’s Somerset facility in the US

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension

Lupin receives tentative approval from USFDA for Raltegravir Tablets

This product will be manufactured at Lupin’s Nagpur facility in India

Kwality Pharma received approval for Leuprorelin Acetate for injectable suspension from Greece

Venus Remedies gets approval from Malaysian PIC/S GMP for pre-filled syringe facility

The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA