Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH

Lupin receives USFDA approval for Brivaracetam Tablets

Shilpa Medicare introduces cancer drug Capecitabine 1000 MG dispersible tablet

The product is backed by required scientific proof and comparative bioequivalence studies

Hovione and GEA collaborate to advance continuous tableting

This partnership stemmed from a successful customer-supplier relationship spanning several years.

Alembic receives EIR for oncology injectable formulation facility at Panelav

This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA

JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets

This product is based on Osmotic Controlled Release Oral Delivery System technology

Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer

Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial

Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets

Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022

Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India

Lupin receives tentative approval from USFDA for Drospirenone Tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US