Pharmaceutical firm Strides Acrolab today said it has received current Good Manufacturing Practice (cGMP) approval from the US Food and Drug Administration for its steriles injectable complex in Bangalore.
"The US FDA (Food and Drug Administration), post a GMP and pre-approval inspection approved the company¿s sterile complex at Bilekahalli in Bangalore to be cGMP compliant," the company said in a statement.
During the inspection, no observations were issued under Form 483 (which details problems in manufacturing and quality assurance systems), it added.
The sterile complex has three dedicated blocks manufacturing penicillin, Cephalosporin and injectable in dry powder, liquid vials, prefilled syringes and lyophilised products.
"A Zero 483 approval for compliance in a challenging manufacturing and regulatory environment the Pharma industry is currently facing is indeed a landmark," Strides Acrolab India CEO Venkat Iyer said.
