Marck Biosciences plans to re-apply for FDA certification within next one yr

It received warning letter from USFDA for alleged violations of CGMP for finished pharmaceuticals

Ahmedabad-based Marck Biosciences plans to appoint an external consultant to sort out its US Food and Drug Administration (USFDA) issues, and it plans to reapply for certification within the next 12 months. Meanwhile, the company plans to prepare its answers in response to the FDA warning letter issued to its Kheda plant.

Bhavesh Patel, managing director of Marck Biosciences (which has re-branded itself as Amanta Healthcare) said that "The FDA has suggested that we appoint an external consultant to help us address the issues raised by the US drug regulator, and we plan to do that." Meanwhile, he also mentioned that while the USFDA letter is dated July 8, the company received it only a few days back, and hence, would seek some more time from the FDA to prepare its answers.

Patel also noted that while the FDA officials had visited the plant in November last year, this warning letter came in so late. "We are also quite puzzled as to why the US FDA has issued this letter nine months after there was filing of our response and completion of compliance which was subsequently validated by inspections undertaken by the health authorities of other countries." He also claimed that as Marck Biosciences is currently not exporting to the US, the import alert issued by the FDA will not have any practical impact.