Eugia SEZ’s injectable facility gets EIR from USFDA

The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated

Arkema grants technology license to Seqens to manufacture PEKK for sale in medical implantable applications

PEKK is a high-performance polymer family used in aerospace and other demanding markets

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).

USFDA inspection of Lupin’s Nagpur injectable facility with zero 483 observations

Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus

Bristol Myers Squibb announces Opdivo Plus Yervoy (ipilimumab) improved overall survival for patients with unresectable hepatocellular carcinoma

Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease

Zydus receives final approval from USFDA for Dexamethasone Tablets

Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)

Strides receives USFDA approval for Sevelamer Carbonate Tablets

Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment