Industry News

Glenmark Pharma Monroe, North Carolina (USA) based Facility has received a communication from the US FDA indicating the inspection classification as Official Action Indicated (OAI).

The OAI classification implies interalia that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.

Global pharma major Lupin Limited (Lupin) has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Formoterol Fumarate Inhalation Solution.

Micro Labs, makers of Dolo 650, has said that these are baseless allegation over Rs. 1000 crore freebies to doctors. FMRAI - a body of medical representatives alleged that the pharma company that makes Dolo spent Rs 1,000 crores in the form of freebies to doctors as incentives for them to prescribe the drug, and the matter subsequently came under the scanner of the Supreme Court.

Indian pharmaceutical sector will log a moderate revenue growth of 7-9 percentage (pc) this fiscal, similar to the last fiscal, due to headwinds in export sales in the regulated markets and high-base effect in the domestic formulations business, reported by CRISIL which studied 184 drug makers that account for 55 pc of the Rs 3.4 lakh crore-a-year sector revenue.

Axsome Therapeutics, Inc a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults.

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world. In India, The Company has strong skills in product development, process chemistry and manufacturing complex API as well as dosage forms.

Johnson & Johnson has announced that it will discontinue talc-based baby powder worldwide after two years of withdrawing sell of talc-based baby powder in the United States and Canada. The company will stop selling the product in the global market from 2023.

FDA found out cancer causing impurity in commonly used anti-diabetic medicines,  sitagliptin and notified in Drug safety report. FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes mellitus.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Prochlorperazine Maleate tablets, USP 5 mg and 10 mg.

Prochlorperazine tablets are used to treat nervous, emotional, and mental conditions (eg. schizophrenia) and non-psychotic anxiety. It is also used to control severe nausea and vomiting. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.