Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
The demand in Africa for COVID-19 vaccines has declined
The exclusive agreement between AAHI and Croda includes a collaborative effort in research and development
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This facility manufactures APIs & formulations of oncology and non-oncology products.
Sun Pharma's Dadra facility receives OAI status from US FDA
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
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