Industry News

Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals, Inc. (Salix).

Sun Pharma records growth of 13.1 percent over Q2 last year.  The gross sales reached at Rs. 108,092 million. In this quarter, the company launched 34 new products in the Indian market.

Sun Pharma market share has increased by 0.5 pc to 8.6 pc over the last one year, as per AIOCD AWACS MAT Sept-2022 report. As per SMSRC MAT August-2022 report, Sun Pharma is topped in prescriptions with 12 different doctor categories.

Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce it has launched their Fingolimod Capsules, 0.5 mg, the generic version of Gilenya®1 Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation.

Commenting on the launch, Sanjeev Krishan, President, Glenmark North America said, “We are very pleased to bring to market a lower cost alternative to Gilenya® Capsules, 0.5 mg. This launch confirms our commitment to provide quality and affordable pharmaceutical products to patients.”

Novavax, Inc a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S.

Lupin Biotech manufacturing facility in Pune receives 17 observations after prior approval inspection by US FDA.

The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility.

The U.S. FDA conducted a Prior-Approval Inspection at Lupin’s Biotech manufacturing facility in Pune, India in October 2022. The inspection concluded with the issuance of a Form 483 with seventeen observations.

Lupin signs an agreement to acquire all rights to two inhalation medicines, Brovana (arformoterol tartrate) Inhalation Solution and Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, from Sunovion Pharmaceuticals Inc. (Sunovion) for a purchase price of around USD 75 million, which is more than 600 crores in Indian rupees.

Inhalation portfolio of Lupin expands in the US with these acquisitions of Brovana and Xopenex HFA.

GSK plc announced that the US Food and Drug Administration has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option.

Hetero announced the acquisition of a brownfield manufacturing plant at Penjerla located in Telangana from Johnson & Johnson.

The facility spread across 55.27 acres, will be Hetero’s flagship sterile pharmaceutical and biologics manufacturing unit, bolstered by state-of-the-art technology.

US based Baxter started its global pharmaceuticals research and development (R&D) centre in Ahmedabad, India. This centre will also support Baxter's global manufacturing facilities, including those in Ahmedabad, Germany, Ireland, Italy, and the United States, among others.