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The agency conducted an inspection at Indoco's manufacturing facility for oral dosage form (Baddi -III), from 22 May to 25 May 2023.
The EU GMP certification issued by the German Health Authority (Berlin) confirms that the site complies with the Good Manufacturing Practice requirements as referred in the EC Directive. The EU certification will support supplies of drug products registered in Europe, from this manufacturing site.
Commenting on the development, Aditi Panandikar, managing director, Indoco Remedies, said, “The EU GMP certification for our site in Baddi adds to our consistent efforts to supply quality and affordable medicines in Europe. We are committed to being cGMP compliant and supplying quality products to our customers and patients across the globe.”
Indoco Remedies is engaged in the manufacturing and marketing of Formulations (finished dosage forms) and active pharmaceutical ingredients (APIs).
The pharmaceutical company's standalone net profit tumbled 37.16% to Rs 25.37 crore in Q4 FY23 from Rs 40.37 crore recorded in Q4 FY22. Revenue from operations grew by 6.94% year on year to Rs 428.05 crore in the quarter ended 31 March 2023.
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