Lupin Ltd

New Delhi: Mumbai-based drugmaker Lupin Limited announced that the US Food and Drugs Administration (FDA) has issued four observations for the company’s Pune Biotech facility . In a stock exchange filing Lupin disclosed, under a product-specific pre-approval inspection of the Company’s Pune Biotech facility conducted from September 8 to 19 has been closed with four observations. Without disclosing the nature of observations the company stated, "We will address the observations and respond to the FDA within the stipulated time frame." The FDA issues an observation if it observes that certain conditions may violate the Food, Drug, and Cosmetic (FD&C) Act or related laws. However the observations are early warning of potential compliance issues and allows the company to address them before further regulatory action is considered. By Online Bureau ,

Mumbai: Lupin Limited Nagpur-based injectable Injectable facility has received six observations from the US Food and Drugs Administration ( FDA ). In a stock exchange filing the company disclosed that the US drug regulator undertook an inspection of its Nagpur injectable facility from September 8 to 16 and has issued six observations. Without disclosing the nature of observations the drugmaker stated, “We will respond to the USFDA within the stipulated time frame and are committed to be compliant with CGMP quality standards across all our facilities.” The FDA issues an observation if it observes that certain conditions may violate the Food, Drug, and Cosmetic (FD&C) Act or related laws. However the observations are early warning of potential compliance issues and allows the company to address them before further regulatory action is considered. By Online Bureau ,

Mumbai: Lupin Limited announced that its ANDA application for Lenalidomide capsules has received approval from the US FDA. Lenalidomide, a cancer drug , is bioequivalent to Bristol-Myers Squibb ’s blockbuster brand Revlimid, which is indicated for the treatment of Multiple myeloma (MM)--a type of blood cancer. Besides the Innovator, presently a generic version of Revlimid is marketed by Dr Reddy’s Laboratories based on a settlement with Celgene , a subsidiary of Bristol-Myers Squibb. According to IQVIA estimates, as of July this year Lenalidomide Capsules had a moving annual turnover (MAT) of $7.5 billion (around Rs 64,000 crore) in the US. Lupin will manufacture its generic tablets at its Pithampur facility in India. Revlimid is an immunomodulatory drug which binds a protein called cereblon, to disrupt the growth and promotes the death of malignant cells. Additionally, it modulates the immune system by enhancing the activity of T cells while subsequently suppressing inflammatory cytokines that support tumor growth. The drug was developed by Celgene, a company later acquired by Bristol-Myers Squibb for $74 billion–the largest acquisition in the company’s history to date. By Online Bureau ,