COVID-19 vaccine from Novavax over 90 per cent effective in US trial
Novavax has begun its regulatory filing in India in partnership with the Serum Institute of India, which is contracted to make…
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Lupin gets warning letter from US FDA for Somerset facility
The US FDA had inspected the Lupin Somerset site from September 10, 2020, to November 5, 2020
Natco gets US FDA approval for Carfilzomib vials
The parties have received final approval for 10 mg and 60 mg strengths of the product and tentative approval for 30 mg strength of…
Lupin gets UK marketing authorisation for Luforbec 100/6 µg pMDI
Luforbec 100/6 µg pMDI is indicated for regular treatment of asthma and for the symptomatic treatment of patients with severe COPD
Planning to expand or set up new pharma-biopharma analytical Lab, but high investments becoming…
As the cost of bringing drugs to market continues to grow, time associated with it is reducing day by day, but the expectation…
Confidently Detect and Quantify Mutagenic Impurities in APIs and Drug Products
Mutagenic impurities in APIs and drug products pose a significant risk to health and safety—even in small quantities—and thus are…
How can you comply with USP <1058> AIQ?
Regulated laboratories must demonstrate that analytical instruments are suitable for their intended use. U.S. Pharmacopeia general…
No plans to enter vaccine production as it needs different manufacturing infra: Dilip Sanghvi
The company is eyeing biosimilars to fuel its future growth
Zydus Cadila gets tentative US FDA approval for Brivaracetam tablets
Brivaracetam is used to treat partial-onset of seizures (epilepsy)
Bharat Biotech shares full research data of COVAXIN
The company also promised to share Phase III trials data from the final analysis soon