Industry News

Lupin Limited announced that it has entered into an exclusive licensing agreement with I'rom Group Co. Ltd (Irom), a leading pharmaceutical company in Japan. Under the terms of the Agreement, Irom will conduct clinical trials along with Lupin, register, distribute and market biosimilar Denosumab in Japan on an exclusive basis.

The Subject expert committee, SEC of CDSCO recommended grant of permission for manufacturing and marketing and permission to conduct the Phase IV Clinical trial of Sovateltide injection by Pharmazz India.

Pharmazz India has submitted an application to receive permission for manufacturing, marketing and conduct phase IV trial in the country. Earlier SEC meeting held on 28.06.2022, the firm presented a proposal for permission for manufacturing and marketing along with Phase IV Clinical trial protocol before the committee.

National Pharmaceutical Pricing Authority, NPPA has rejected the application of Intas Pharmaceuticals for exemption from the provisions of Drug Price Control Order, DPCO, 2013 under Para 32 (iii) for the formulations Clozapine Extended Release Capsules.

The expert committee of NPPA had received application from Intas Pharmaceuticals for exemption from the provisions of DPCO 2013 under para 32 (iii) for the formulations Clozapine extended release capsules 12.5 mg, 25 mg, 50 mg, 100 mg and 200 mg.

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.