KUALA LUMPUR: Hartalega Holdings Bhd will submit an application to the US Food and Drug Administration (FDA) by mid-April to market its anti-microbial gloves in the country this year.
Managing director Kuan Mun Leong said the FDA application
involves various technical papers and guidelines that must be met for approval.
"We will submit (the application) to the FDA between mid-April 2018 and end of May 2018.
"The process of getting approval will take between six to nine months," he told a news conference after the company's extraordinary general meeting (EGM) here today.
Hartalega's anti-microbial medical gloves, developed in collaboration with UK-based researchers, provide additional protective coverage to prevent infection during medical examinations.
Hartalega plans to launch the product in the Europe next May.
At the EGM, Hartalega has obtained shareholders' approval for the issuance of bonus shares up to 1.714 billion new shares in Hartalega.
The bonus issuance is on the basis of one bonus share for each existing share held by the shareholders, with the entitlement date to be determined later.
Kuan said the bonus issue would enable the company to increase liquidity, and with larger share size, it would promote stock trading.
The Group posted a net profit of RM113.1 million in the third quarter ended December 31, 2017, representing an increase of 70.4 per cent compared to the corresponding quarter of the previous year.
The earnings is derived from an increase of 32.2 per cent to RM603.1 million.
Hartalega posted a cumulative net profit of RM323.3 million for the nine months, representing a 66.7 per cent increase over the corresponding period of the previous year.
CIMB Equities Research expects Hartalega to be on a solid footing to chart stronger fourth quarter results, backed by the Group’s new production line capacity at the Next Generation Integrated Glove Manufacturing Complex (NGC).
The NGC in Sepang comprises seven manufacturing plants of which four are currently fully operational.