Aurobindo Pharma after being issued an alert for its unit VI, which makes oral and sterile (or injectable) cephalosporins, has now received the warning letter from US Food & Drug Administration (USFDA) detailing their observations.
In addition, based on a field alert report for packaging and labeling compliance for unit III, the USFDA has also asked the company for submission of a detailed action plan for improvement in this letter. This action plan is required to be submitted within 15 working days and USFDA has also given an opportunity for regulatory meeting at their office.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.
