JAKARTA — PT Fonko International Pharmaceuticals has recorded several key milestones in the development of oncology drug manufacturing in Indonesia. These achievements include securing European Union Good Manufacturing Practice (EU GMP) certification in 2025, developing a range of “first copy” products for cancer therapy, and obtaining halal certification for its entire oncology product line.
This progress builds on Fonko’s ongoing commitment to expanding domestic production capacity for oncology drugs, which has reached 4 million vials per year for injectable products. The company’s specialized production facility in Cikarang, West Java, was inaugurated in 2014 to improve access to high-quality cancer therapies while reducing reliance on imports. By the following year, Fonko was supplying oncology products to the domestic market, addressing a critical need recognized by the government as requiring sustained investment and advanced technology. In 2018, Fonko marked its first international export to Cambodia.
A major milestone was reached in 2025 when Fonko obtained EU GMP certification for its oncology manufacturing plant. The certification confirms that its manufacturing processes adhere to the strict quality standards enforced across the European Union, going beyond national requirements. Ahead of the certification, Fonko underwent extensive preparation, including mock-up inspections facilitated by the Indonesian Food and Drug Authority (BPOM) to ensure compliance with global standards.
For Fonko, this milestone expands its capacity to deliver oncology products that meet international market standards. The EU GMP certification also enhances the global competitiveness of Indonesia’s national pharmaceutical industry, particularly in specialized fields like oncology.
“For us, this achievement ensures that every process at Fonko meets a consistent and accountable standard of quality. Embracing global standards is part of our effort to continuously elevate Indonesia’s oncology manufacturing capabilities,” said Lany Wijaya, Operations Director of PT Fonko International Pharmaceuticals.
Developing “First Copy” Products
This enhancement of manufacturing capability has progressed alongside product innovation. Fonko recorded a significant milestone by developing “first copy” products in Indonesia for several key oncology drugs, including Bendamustine, Bortezomib, Pemetrexed, and Vinorelbine.
Developing these therapeutics carries strategic importance given the complex, stringent quality requirements associated with oncology drug production. Producing them locally expands the national industry’s capacity to offer varied therapeutic options to patients.
Bendamustine serves as a prime example. Fonko began developing products featuring this active ingredient in 2014, providing treatment options for non-Hodgkin lymphoma patients while contributing to import substitution efforts.
In addition to Bendamustine, Fonko produces other critical oncology drugs such as Bortezomib and Pemetrexed, further enriching the domestic oncology portfolio. According to Dexa Group data, several of Fonko’s oncology products have been integrated into the national procurement ecosystem and feature significant local content.
“Developing first-copy products requires precision, expertise, and consistency,” noted Lany. “We want to ensure these capabilities continue to evolve so that Indonesia is not merely a market for healthcare products, but a producer capable of manufacturing high-quality oncology drugs domestically.”
100% Halal-Certified Oncology Line
Another key milestone involves product assurance: Fonko’s entire oncology portfolio is now halal-certified. This reflects the company’s dedication to providing health products that not only meet high quality and safety standards, but also respect the cultural and religious needs of Indonesian patients.
This initiative aligns with the broader push to strengthen Indonesia’s halal pharmaceutical ecosystem. Beyond manufacturing and management system certifications, Fonko holds an official Halal Assurance System (SJH) certification.
Lany emphasized that halal compliance is an integral part of the company’s holistic operational standards.
“We treat quality, regulatory compliance, and halal requirements as inseparable parts of the drug production process,” Lany added. “As a result, our products not only meet rigorous manufacturing standards, but also provide peace of mind to the patients who rely on them.”
These achievements mark a vital step in Fonko’s efforts to solidify Indonesia’s position in national oncology manufacturing. Moving forward, the company plans to continuously advance its production capabilities, product line, and quality standards to meet evolving cancer treatment needs—aiming to remain resilient, technology-driven, and adaptable to global standards while boosting the independence and competitiveness of the Indonesian pharmaceutical industry.