The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
Lupin’s subsidiary in Philippines, Multicare Pharmaceuticals, will file for marketing approval and be responsible for distribution and commercialization of the biosimilars once approved.
Proceeds from the proposed issue will be utilized to part finance Balaxi’s planned EU GMP-compliant manufacturing facility for Oral Solid Dosages and Liquid Injectables at TSIIC Pharma Formulations SEZ
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares
NATCO to sell 15% of shareholding in Nativita for euro 3,45,000 to Pharmasyntez-Nord
The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors
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