PETALING JAYA: Pharmaniaga Bhd is scaling up local insulin production with capacity capable of supplying Malaysia’s entire annual demand and has already received interest from Indonesia and Central Asia.
Managing director Datuk Zulkifli Jafar said Malaysia currently requires nearly 21 million insulin cartridges annually, while Pharmaniaga’s existing production capacity can already reach 25 million cartridges a year under two-shift operations.
“Which means we have sufficient capacity to supply for the whole country,” he told reporters after the group’s 28th AGM and EGM today.
Zulkifli said the company could eventually raise production capacity to nearly 40 million cartridges annually if operations are expanded to three shifts, potentially enabling exports beyond Malaysia.
“If we change from two shifts to three shifts, then we can increase to almost 40 million cartridges a year. So we can then supply to other countries in the world,” he said.
He said Pharmaniaga is currently prioritising domestic government supply commitments after securing a human insulin supply contract worth about RM282 million over three years, alongside separate tenders involving teaching hospitals.
“At the moment, our focus is on the government first for this year. But of course there is interest from Indonesia. There is also interest from Central Asia to buy our human insulin,” he said.
The company is targeting full production capability of 25 million cartridges annually by early 2028.
Pharmaniaga is currently supplying insulin through trading arrangements involving imported finished products while progressively transitioning towards localised manufacturing at its Puchong plant.
Zulkifli said the current commencement of insulin supply mainly refers to trading imported finished insulin products, while localisation refers to insulin manufactured directly at Pharmaniaga’s own facility.
“The difference is when we start commencing supply, we are doing trading first. So when we localise it, it is produced in our plant in Puchong,” he said.
He said Pharmaniaga has already received approval for smaller-scale insulin production batches and is currently seeking approval from the National Pharmaceutical Regulatory Agency (NPRA) to scale up production capacity from 50 litres to 500 litres.
Under pharmaceutical manufacturing regulations, larger-scale production still requires fresh regulatory approval and stability testing even if the product and facility remain unchanged.
“When you want to increase from 50 litres to 500 litres, even though it is the same plant, you still have to go back to NPRA to get approval,” Zulkifli said.
He said NPRA requires six months of stability data before granting approval for larger-scale insulin production.
“They are concerned about the stability of the insulin, so they have to run the test. They need six months of data to show that it is stable before granting approval,” he said.
Pharmaniaga expects localisation activities to commence in the third quarter of 2026.
For the initial phase, the company said insulin supplied to the government will primarily be sourced through trading arrangements to ensure uninterrupted supply continuity while local manufacturing capacity scales up gradually.
“For the first year, we are supplying based on trading. We want to make sure there is sufficient supply to the government,” Zulkifli said.
He said the insulin business is projected to generate margins of about 30% this year, with profitability expected to strengthen to roughly 40% over the next two years as Pharmaniaga gradually transitions from lower-margin imported insulin trading towards higher-margin local manufacturing and in-house production.
He said the insulin business is expected to contribute about RM8 million at the profit-before-tax (PBT) level this year and approximately RM17 million next year, excluding contributions from teaching hospitals and military hospital supply contracts.
