Sharon Bio Medicines receives FDA approval for Tajola API plant

Indian Pharmaceutical company Sharon bio medicine Ltd said it received the Establishment Inspection Report (EIR) from United States Food and Drug Amnistration for its manufacturing plant located at Tajola in Raigad Dist., Maharashtra.

The plant, which will make Active Pharmaceutical Ingredients is now approved by the USFDA and the generic drug user fee is pending.

“The supply of API to United States of America cannot be done unless generic drug user fee is paid,” it said.

Sharon Bio Medicine is a manufacturer of Intermediates, Active Pharmaceutical Ingredients and Finished Dosage Forms with an annual turnover of over $130 million, with 500 personnel & market presence in over 40 countries worldwide.