Unichem Laboratories announced today, 13 August 2019, that it received Abbreviated New Drug Application (ANDA) approval from US Food and Drug Administration (USFDA) for Unichem's Tramadol Hydrochloride tablets USP, 50 mg, a generic version of Ultram tablets of Janssen Pharmaceuticals, Inc. The drug is indicated to adults for the management of pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The product will be commercialized from Unichem's Ghaziabad plant.
In a separate announcement yesterday, the company said it received ANDA approval from USFDA for Chlorthalidone tablets USP, 25 mg and 50 mg, a generic version of Hygroton tablets of Sanofi Aventis US, LLC. The drug is indicated for the management of hypertension either as the sole therapeutic agent or to enhance the effect of other anti-hypertensive drugs in the more severe forms of hypertension. It is also indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. It also treats edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. The product will be commercialized from Unichem's Ghaziabad plant.
Unichem Laboratories' reported a consolidated net loss of Rs 6.19 crore in Q1 June 2019 compared with net loss of Rs 20.46 crore in Q1 June 2018. Its net sales surged 23.5% to Rs 297.74 crore in Q1 June 2019 over Q1 June 2018.
Unichem Laboratories is an international, integrated and specialty pharmaceutical company.