Biocon all clear, Dr Reddy's stays under scrutiny: US FDA Indian audit round-up

By Dan Stanton

- Last updated on GMT


Related tags Bombay stock exchange Food and drug administration Fda

The US FDA has issued Establishment Inspection Reports (EIRs) closing out inspections at Biocon’s biomanufacturing plant in Bangalore and a Divi’s Lab facility in Visakhapatnam.

A visit to Biocon’s Plot 2-4 Phase IV facility in Bangalore, India in May by the US Food and Drug Administration (FDA) ended with a Form 483 with 10 deviations​ from current good manufacturing practice (cGMP).

But the FDA has issued an Establishment Inspection Reports (EIR) and placed the facility on ‘voluntary action indicated’ (VAI) status, according to a letter​ filed by Biocon with the Bombay Stock Exchange this week.

“The FDA has classified the outcome of this inspection as VAI and the EIR states that the inspection is closed,”​ the firm said.

Among other products, Biocon manufactures biosimilar products co-developed with Mylan from the Bangalore site. In August​ the FDA pushed back the action date on the firms’ Herceptin (trastuzumab) biosimilar by three months, though Biocon told Biopharma-Reporter at the time the target date extension was “linked to the review of the clarificatory information sought as part of the application review process,”​​ and “not related to any cGMP audit observations.”

The facility has also felt regulatory pressure from European regulators. An inspection in March by France’s regulatory body ANSM (Agence Nationale de Sécurité du Médicament) resulted in a statement of non-compliance with GMP being issued to the firm in July​​, citing 35 issues at the facility.

Divi’s Laboratories

In September, an FDA audit of Divi’s Laboratories Limited API facility in Visakhapatnam (Vizag), India – known as Unit-2 – ended with a Form 483 detailing six observations.

But Divi’s has since issued a note​ on the Bombay Stock Exchange announcing the closure of the audit.

“We wish to inform you that we have now received an Establishment Inspection Report (EIR) from US-FDA for our Unit-II, as closure of audit by FDA.”

Dr Reddy’s

Meanwhile, a Dr Reddy’s Laboratories finished formulation facility in Duvvada, Andhra Pradesh has also received an FDA EIR but the audit remains open, the firm said, also in a regulatory filing​ this week.

“In the cover letter to the EIR, FDA has explained that the inspection has not closed and the site’s status remains unchanged, but that FDA has released the EIR in order to be transparent about its regulatory process.”

The facility was hit with a warning letter​​ in November 2015, and in March this year​ a re-inspection resulted in a Form 483 with 13 observations

“We are planning to request a re-inspection in 2018 after further discussion on scheduling with FDA,”​ the firm said.

Related news

Show more

Related products

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

A Guide Through the API Drug Development Pipeline

A Guide Through the API Drug Development Pipeline

Content provided by Lonza Small Molecules | 11-Jul-2023 | Insight Guide

With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...

Understanding the hidden value of quality

Understanding the hidden value of quality

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | White Paper

The raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success.

Related suppliers

Follow us


View more