INDIA – Sun Pharmaceutical Industries Limited (Sun Pharma) has expanded its product portfolio with the launch of its novel anti-cancer drug Palbociclib under brand name ” PALENOTM ” in India.
Palbociclib is approved by the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) and Central Drugs Standard Control Organisation (CDSCO) in combination with hormonal therapies for the advanced treatment of metastatic breast cancer.
The Indian pharmaceutical giant announced that its new drug for advanced breast cancer treatment will be available in the form of hard capsules in strengths of 75 mg, 100 mg, and 125 mg.
Sun Pharma disclosed that it is introducing a unique patient assistance program that will improve patient compliance and accessibility with an aim to broaden access to its innovative breast cancer drug.
In a press release, Kirti Ganorkar, Chief Executive Officer (CEO) of India Business, Sun Pharma, said: “We are introducing Palbociclib at an affordable price which will help improve patient access.”
He underscored that PALENOTM will address the treatment need of several advanced breast cancer patients in India, noting that it is the largest form of cancer in India, affecting approximately 0.21 million new female patients every year.
The product will be made at the Company’s manufacturing facilities in India that are approved by global regulatory agencies including USFDA.
However, the US health regulator has issued a warning letter to Sun Pharma for significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at its Gujarat-based plant.
The US FDA pointed out the company’s failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products at its Halol facility after an inspection report made last year.
It cited significant violations of good manufacturing norms at the Halol plant particularly its methods, facilities, and controls for manufacturing, processing, packing, or holding of drug products did not conform to CGMP.
The regulator said that Sun Pharma firm’s failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products.
“Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas,” the FDA informed.
The health regulator outlined in its warning letter that failure to address violations may result in the FDA refusing admission of articles manufactured at Sun Pharmaceutical Industries Ltd, Halol, into the United States market.
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