 "AstraZeneca to shut down API unit in Bengaluru")
AstraZeneca Pharma India will to close the active pharmaceutical ingredient (API) manufacturing unit at its Bengaluru site as the company has decided to stop the production of terbutaline sulphate – the only product being manufactured at the unit. However, the company’s tablet manufacturing plant, which started commercial operations in 2013, will continue to operate at this site, said AstraZeneca in a BSE filing on December 3, 2015.
The decision (to close down API unit) was taken following an application to the Drug Controller General of India (DCGI) to withdraw the manufacturing licence for TBS, said AstraZeneca Pharma India. The product was manufactured primarily for export and the company applied to withdraw the licence following low demand in the export markets.
“The Board took the decision as terbutaline sulphate (TBS) was the last API to be manufactured at the API unit and no other API manufacturing activity is planned to be carried out at this unit in the future,” the company said.
Terbutaline sulphate is used in formulations that are used to treat bronchospasm in patients with asthma and reversible bronchospasm associated with bronchitis and emphysema.
The decision (to close down API unit) was taken following an application to the Drug Controller General of India (DCGI) to withdraw the manufacturing licence for TBS, said AstraZeneca Pharma India. The product was manufactured primarily for export and the company applied to withdraw the licence following low demand in the export markets.
“The Board took the decision as terbutaline sulphate (TBS) was the last API to be manufactured at the API unit and no other API manufacturing activity is planned to be carried out at this unit in the future,” the company said.
Terbutaline sulphate is used in formulations that are used to treat bronchospasm in patients with asthma and reversible bronchospasm associated with bronchitis and emphysema.