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The company is a vertically integrated global pharmaceutical company headquartered in Bangalore.
The audit was carried out related to a product filed from the new, semi-solids block from where the company has made a series of filings.
With the recently closed Establishment Inspection Report (EIR) announced on June 7, 2016, the entire facility is now USFDA compliant.
The Oral Dosage facility in Bangalore manufactures oral dosage forms including tablets, capsules (both hard and soft gelatine), ointments and liquids.
The manufacturing plant supports important current and future submissions for the US market.
The company has global manufacturing foot print with 14 manufacturing facilities spread across 3 continents, including 6 USFDA approved facilities and 8 facilities for the emerging markets.
It also has 3 dedicated R&D facilities in India with global filing capabilities, and a strong commercial footprint across 85 countries.
