With USFDA approval for generic Indian drugs, Indian pharma companies can now strengthen their presence in the US market
The COVID-19 has come as a blessing in disguise for Indian pharma companies that were earlier prohibited from entering US markets due to the stringent protective stance of US Food and Drug Administration.
In a noteworthy sequence of events, the United States Food and Drug Administration (USFDA) has given the nod to Indian pharmaceutical companies to market their generic versions of essential and life-saving drugs in the United States of America. This comes after India's decision to ease export restrictions on hydroxychloroquine to the US. Hydroxychloroquine is an antimalarial drug which, in combination with the antibiotic azithromycin, has shown some efficacy in treating the COVID-19 disease.
Cipla, a leading drug manufacturer in the respiratory-illness segment, said that it had received final approval from the USFDA for its product – Albuterol Sulfate inhalation aerosol – on Thursday. The product is the generic version of Merck Sharp & Dohme Corp's Proventil HFA inhalation aerosol and is used in the treatment of bronchospasm and prevention of asthmatic symptoms. In a statement, Cipla said that it plans on shipping the product to the US in a staggered manner.
Lupin too has a filing for Albuterol pending with the US health regulator, and it is expected that the USFDA might prioritise the approval.
Granules India said, also on Thursday, that its foreign subsidiary had received approval from the USFDA for Butalbital, Acetaminophen and Caffeine capsules used to treat tension headaches. Granules India's products are the bioequivalents of Butalbital, Acetaminophen and Caffeine capsules of Nexgen Pharma.