The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026
The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026
The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets
The newly approved pill combines 100 mg of doravirine with 0.25 mg of islatravir
The facility was inspected from May 7 to May 17, 2024
Submission based on results from pivotal phase III trial showing all primary endpoints met
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
The product will be manufactured at Lupin’s Nagpur facility in India
The inspection classification was determined by the agency as Voluntary Action Indicated
Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)
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