Solara Cuddalore facility successfully completes USFDA inspection

Published On 2019-07-08 04:05 GMT   |   Update On 2019-07-08 04:05 GMT

Chennai: Solara Active Pharma Science Limited (Solara), an Active Pharmaceutical Ingredient(API) provider recently announced the successful completion of USFDA inspection at the multi-product manufacturing facility at Cuddalore with ZERO 483s inspectional observations.


The current USFDA inspection at the facility was scheduled and completed between 1St July and 5th July 2019.


The Cuddalore multi-product API manufacturing facility was established in the year 1991 and is equipped with appropriate infrastructure to include several independent production blocks and related packaging sections.


This site is inspected by various Regulatory Authorities including US FDA, MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS.


"Solara continues to stay focused on maintaining the highest level of compliance across its manufacturing facilities. This is Company’s third consecutive USFDA audit with “Zero 4835”," said Solara.


"In Dec’ 18 and Jan’19, the company also completed USFDA inspections at Solara Research Centre(SRC), Chennai and Ambernath manufacturing facility with zero 4833," the company added.


Also Read: Biocon gets dozen USFDA observations for 3 units in Malaysia

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