“The US FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with 6 observations,” a Biocon spokesperson wrote in a letter filed with the Bombay Stock Exchange this morning.
“As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner.”
In-Pharmatechnologist reached out to the Bangalore, India-based company for further details:
“These observations are suggested procedural improvements and not related to non-compliance and as such do not have any material impact,” we were told.
The facility, located at the Bio-XCell biotechnology park in Johor, Malaysia, makes insulin active pharmaceutical ingredient (API), insulin analogues and finished products.
Biocon began constructing the facility in 2011 to produce insulin for Pfizer under a 2010 contract, and commercial operations commenced in 2017.
Among the commercial products made at the plant is Biocon’s rh-insulin, Malaysia’s first locally made biosimilar insulin to be approved by the National Pharmaceutical Regulatory Authority (NPRA). The facility also makes the firm’s insulin glargine brand, Basalog – a biosimilar to Sanofi’s Lantus – for a number of markets.
Last April, an inspection by Ireland’s Health Products Regulatory Authority (HPRA) resulted in the facility receiving a European GMP certificate dated September 6 2017. The certificate can be found below.
The news is the latest regulatory issue to hit Biocon. A facility in Bangalore – which also makes biosimilars – was criticised by European and US regulators last year.