Biocon’s Malaysian Plant Gets Six Observations From U.S. Drug Regulator
The U.S. FDA issued Form 483 with six observations to Biocon for its Malaysian unit.
Biocon Ltd. said the U.S. drug regulator has issued form 483 for its Malaysia plant with six observations.
“As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner,” the Bengaluru-based company said in its exchange notification. Form 483 is used by the U.S. Food and Drug Administration to document and communicate concerns discovered during plant inspections.
The Malaysian unit, run under the Mylan-Biocon partnership, is largely focused on insulin variants and had filed an approval for making glargine, Cyndrella Carvalho, senior research analyst at Dolat Capital, told BloombergQuint.
It is a pre-approval inspection because they do not manufacture anything in that unit as of now. We have to wait and go through form 483 to understand if there is anything on the negative side.Cyndrella Carvalho, Senior Research Analyst, Dolat Capital
If the plant has any deficiencies, the U.S. FDA approval will not come in but the six observations should not be anything serious as the plant has not started manufacturing yet, Carvalho said.
Shares of Biocon were down 1.48 percent to Rs 564, falling for the third straight session, as the market opened after the company's announcement.
I would advise investors to book profit if they have already entered the stock and maybe shift to Aurobindo Pharma, Natco Pharma, Ajanta Pharma, Strides Shasun or Alkem Laboratories.Gaurang Shah, Head-Investment Strategist, Geojit Financial Services Ltd.