Indoco Remedies says no observation from USFDA for Kilo Lab unit
India Infoline News Service | Mumbai | May 18, 2018 18:59 IST
The Kilo Lab facility received zero 483s from the agency, while its API plant at Patalganga cleared the inspection with 3 observations; none of them are critical or pertain to data integrity.
Indoco Remedies announced successful completion of USFDA inspection of API manufacturing facilities at Patalganga and Rabale, Navi Mumbai.
The Kilo Lab facility received zero 483s from the agency, while its API plant at Patalganga cleared the inspection with 3 observations; none of them are critical or pertain to data integrity.
The routine inspection was conducted at Patalganga facility from May 7 to May 11, 2018 and Kilo Lab facility at Rabale from May 14 to May 17, 2018.
During the audit, the FDA thoroughly inspected Indoco's entire quality management systems to ensure compliance with federal regulations. The inspection included a review of production facility, processes and procedures, training records, quality systems and control procedures.
Indoco Remedies is engaged in the business of formulations (94% of FY17 revenue) and APIs (6%). It offers products for various therapeutic categories, such as stomatologicals, respiratory, anti-infectives, gastrointestinal, pain/analgesics etc. It derived 59% of FY17 revenues from domestic markets, with Europe, USA and emerging markets contributing 16%, 12%, 13%, respectively.
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