AstraZeneca Pharma India Ltd. on Thursday said that it has received the permission to import a new drug formulation into India.
According to the exchange filing, regulatory authority Central Drugs Standard Control Organisation has allowed it to import pharmaceutical formulations of its drug Eculizumab for sale or for distribution in India.
Eculizumab is a drug that treats rare blood diseases like paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. It stops the body from destroying its own red blood cells.
"The receipt of this permission paves way for the launch of Eculizumab Concentrate for solution for infusion 300 mg (10mg/ml) (SOLIRIS) in India for the above specified indications," the filing stated.
Last month, the drugmaker's India president and managing director Sanjeev Panchal had told NDTV Profit that it is bringing “innovative medicines” to the country, but it needs to be distributed to a larger population.
He said this while talking about the drugmaker's deal with Mankind Pharma to distribute asthma drug Symbicort that he said will help the company reach more patients across the country.
The pact with Mankind Pharma, announced in March 2024, was an exclusive agreement for distribution of budesonide and formoterol fumarate dihydrate drug under the brand name of Symbicort, which is a product of British-Swedish drugmaker AstraZeneca.
AstraZeneca retains the intellectual property rights to the drug and continues to remain the marketing authorisation holder, whereas its Indian arm holds the import licence for the medicine.
Prior to that, in September, the Indian arm of AstraZeneca had received CDSCO's approval to import and distribute Durvalumab in various formulations.
The approval allowed Durvalumab to be used together with chemotherapy before surgery, and then as a single treatment afterward. Durvalumab is meant for patients with resectable non-small cell lung cancer who have tumors larger than 4 cm or have cancer in the lymph nodes.
Shares of AstraZeneca Pharma India Ltd. closed 0.95% higher at Rs 6,796.10 apiece on the BSE, compared to a 0.42% advance in the benchmark Sensex.
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