Alembic gets USFDA approval for generic heart drug

Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell a generic version of ANI Pharmaceuticals’ hypertension drug Atacand Tablets. Atacand had an estimated market size of US$ 22 million for twelve months ending December 2017 in the US...

Lupin gets USFDA nod for blood treatment drug

Pharmaceutical manufacturer Lupin said it received approval from the US FDA for launching Decitabine injection for treating conditions caused by defective blood cells, known as myelodysplastic syndromes. Decitabine for Injection, 50 mg/vial, Single-Dose Vial had annual sales of approximately USD 135.9 million in the US....

Lupin gets USFDA nod for asthma inhaler drug

Indian pharmaceutical manufacturer Lupin said it received regulatory approval to launch a generic version of AstraZeneca’s asthma inhalation medicine. Budesonide Inhalation Suspension is among medium-sized drugs sold in the United States, with annual sales of around $475 million. It is sold by AstraZeneca under the name...

Lupin launches pneumonia drug Atovaquone in the US

Pharma major Lupin said it has launched pneumonia suspension Atovaquone, a generic substitute for Glaxosmithkline’s Mepron oral suspension. The drug, in the dosage of 750 mg per 5 milliliter, had annual sales of approximately USD 119 million in the US. It is indicated for the prevention...

Lupin’s Nagpur plant passes FDA inspection

Pharma major Lupin said its Nagpur plant has passed a Pre-Approval Inspection by the US Food and Drug Administration without incident. The inspection, carried out in September, was related to the manufacture of Phenytoin Sodium Extended Release capsules to be sold in the US market. Lupin’s Nagpur facility...

Alembic JV clears USFDA inspection at its dermatology plant

Alembic Pharmaceuticals said one of its dermatology-focused joint ventures cleared its first United States Food and Drugs Administration (USFDA) inspection at its new formulation manufacturing facility located at Karakhadi, Gujarat, India without any observations. The inspection was carried out between 15th October, 2018 and 19th...

Sun Pharma gets US FDA okay for eye drug

Sun Pharmaceutical Industries said it has got US Food and Drug Administration  approval for a new eye drug that will be used for lowering intraocular pressure or IOP  in patients with open-angle glaucoma or ocular hypertension. The medicine, latanoprost ophthalmic emulsion, was developed by group company Sun Pharma...