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Corporate - Regulatory Bodies & Rulings
Aurobindo unit gets USFDA nod

Our Bureau

Hyderabad, Jan. 30

Aurobindo Pharma Ltd has announced that the US Food and Drug Administration (USFDA) has approved its API (Active Pharmaceutical Ingredient) facility at Unit-VI to manufacture sterile ceftiofur sodium. This facility is situated on a 15-acre land in Chitkul village, Patancheruvu mandal of Medak district.

It would be possible to make the antibiotic ceftiofur sodium available in injectable form in the regulatory markets with the approval. The company, which has over 180 APIs, has received approvals for most of its formulation facilities from leading regulatory agencies in the US, UK, Canada, WHO and MCC South Africa, according to a press release.

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