SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
KRKA holds 51% and Laurus Labs holds 49% shareholding
The demand in Africa for COVID-19 vaccines has declined
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This facility manufactures APIs & formulations of oncology and non-oncology products.
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
Aims to become a leading global partner for botanical extracts and natural actives in the beauty and personal care market
Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
The company will respond to the Warning Letter within the stipulated timelines
These observations are procedural in nature and will be responded within the stipulated time
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