Regulators in Australia and Europe, including the UK, have sought information from the US Food and Drug Administration (FDA) about the lapses, which last week led to a US ban on imports of products made at the Mohali facility.
The regulators said action will be taken after assessing the FDA’s reply.
Ranbaxy Laboratories, which was acquired by Japanese drug maker Daiichi Sankyo in 2008, commissioned the Mohali plant in 2011 and started exports from there in 2012. It is the third Ranbaxy facility in India to face US action, after the plants in Dewas and Paonta Sahib.
The US FDA banned imports of drugs made at the Mohali unit after it found lapses, including tablets embedded with ‘black fibre’ suspected to be hair from an employee’s arm and ‘black spots’ of oil from machines making their way into tablets.
The drug maker, which has 16 manufacturing units in eight countries and ground operations in 43 countries, said it will continue to fully cooperate with the US FDA and take steps to resolve their concerns at the earliest.
A spokesperson for Australia’s Therapeutic Goods Administration (TGA) told PTI it will determine whether any action is required when the information from the US is assessed.
“The TGA is in communication with the US FDA and is awaiting details to determine whether any Australian medicines may be affected by the FDA findings,” the spokesperson said.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) said an impact assessment is in progress. “We are currently working with the FDA and other European regulators to assess the impact the FDA’s action has on the medicines from the Mohali site that are destined for the UK and European market. There is currently no evidence that medicines on the UK and EU market manufactured at this site are defective so people should continue to take their medicines,” MHRA said.
The World Health Organization did not comment on its action plan, saying only that it had taken note of the US FDA’s past actions against Ranbaxy.
Ranbaxy said in May it signed a consent decree with the US FDA and agreed to pay $500 million to settle charges after a US Department of Justice probe of data integrity and manufacturing processes at certain company units in India.
Ranbaxy clocked over $1 billion sales in the Americas in 2012, while it garnered over $420 million in Europe and over $270 million from Asia and Africa.
Genzyme corp files patent infringement suit against DRL
Hyderabad: Genzyme Corporation, a fully-owned subsidiary of drug major Sanofi-Aventis, has filed a suit against Dr. Reddy’s Laboratories alleging that the Indian drug maker infringed patents of its blockbuster cancer drug Mozobil on three counts.
Mozobil (plerixafor injection) is a hematopoietic stem cell mobiliser indicated to patients with non-Hodgkin’s lymphoma (blood cancer) and multiple myeloma. In its petition filed in the District Court of Delaware, Genzyme alleged that DRL intimated though a letter that it had submitted an Abbreviated New Drug Application with US FDA seeking approval to engage in the commercial manufacture, importation, use, and sale of 20 mg/ml Plerixafor injection as a generic version of Mobozil drug.
Genzyme sought the court to declare that DRL’s making, using, selling, offering to sell, or importing its Plerixafor ANDA Injection Product by DRL is infringement of one or more claims of the patents.
According to Sanofi’s 2012 annual report, Mozobil contributed euro 96 million to its revenues.