Drug maker Ipca Laboratories on Tuesday said that US FDA hasn't carried out any new inspections at three of its manufacturing units under scanner.
Drug maker Ipca Laboratories on Tuesday said that US FDA hasn't carried out any new inspections at three of its manufacturing units under scanner and said that the import ban on certain drugs relates to the change in drug shortage situation in the US market.
Last week US FDA banned almost all the drugs manufactured by the company at three of its facilities that included active pharmaceutical ingredients (APls) manufacturing unit situated at Ratlam (Madhya Pradesh) and formulations manufacturing units situated at SEZ Indore (Pithampur) and Piparia (Silvassa).
"We wish to inform you that our representative enquired with US FDA the reasons for their recent letters to the company's above manufacturing units," the company said in a statement.
"US FDA clarified that the reason for issuing these letters is for withdrawal of exemption on certain drugs which was due to the change in drug shortage situation in the US market," the company added.
"We also wish to further clarify that US FDA has not carried out any new inspection or reinspection of company's above manufacturing units.
Ipca said it remains fully committed in resolving the US FDA issues at the earliest.
"The company is committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture," Ipca said.
The company’s API plant at Ratlam and formulations units at Indore SEZ and Silvassa have been under import alert of the US FDA since 2015 for violation of good manufacturing practices but a few products were exempted from the ban to avoid shortages in the US market.
Now only one API product, chloroquine phosphate manufactured at Ratlam facility, is exempted from the import ban.
“The exception (for chloroquine phosphate) will be reconsidered (by the USFDA) if shortage and/or medical necessity implications change,” Ipca Lab said, in the filing last week.
Ipca Lab’s management has requested a one-on-one meeting with the USFDA to discuss the remediation work done at its plants, after which it would invite the regulator to re-inspect the two formulations units.
The API plant at Ratlam is likely to be offered for re-audit in August-September this year.
"Denial of exempted products in the US along with a weak GBP will likely lead to slow growth in generic exports. While branded generic sales are doing well, IPCA's margin expansion story will be delayed until sales to the US/UK pick up," said CLSA in its report on Ipca.Shares of Ipca rose 1.93 percent and were trading Rs 479.90 on BSE at 11.50 am, the benchmark Sensex gained 0.09 percent to 31,339.10 points.