August 3, 2026 | 05:47 am
TEMPO.CO, Jakarta – PT Selatox Bio Pharma (Selatox) has become the first company in Indonesia to have a manufacturing facility to produce botulinum toxin (botox). Taruna Ikrar, the Head of the National Agency of Drug and Food Control (BPOM), expressed, "Until now, botulinum toxin had to be 100 percent imported. With local production, the prices can be more affordable, ensuring better safety, and Indonesia has the potential to become a global market hub." This was stated during the inauguration of Selatox's biofarmaceutical plant titled 'Pursuing the Highest Quality, Delivering the Finest Beauty' in Cikarang, West Java, at the end of July 2026.
Taruna added that domestic production is a strategic step to expand public access while ensuring the quality and safety of the products. She appreciated PT Selatox Bio Pharma for introducing the botulinum toxin production facility in Indonesia. Taruna mentioned, "To date, there are 5 type A botulinum toxin products approved by BPOM, with indications for both neurological and aesthetic purposes, namely Botox, Letybo, Xeomin, Nabota, and Lanzox. However, all of these products are still imports," Taruna said.
The Good Manufacturing Practice (GMP) certificate of PT Selatox was issued on July 10, 2026. The total time taken from submission to the issuance of the GMP certificate was only 35 working days. Taruna also added that the development of Selatoxin (Botulinum Toxin) through phase 3 clinical trials in Indonesia complies with Regulation No. 34 of 2025 concerning Changes to BPOM Regulation No. 8 of 2024 concerning the Procedures for Approval of Clinical Trial Implementation. "BPOM also encourages PT Selatox to conduct clinical trials related to indications for post-stroke spasticity and other neurological diseases," Taruna Ikrar said.
Botulinum toxin is a protein produced by the bacterium Clostridium botulinum. In very small and purified doses, this substance is used as a drug to relax muscles or inhibit the release of chemicals that activate muscles. The public is more familiar with it as botox.
With the inauguration of the manufacturing facility and the acquired GMP certification, Selatox is committed to supporting the development of Indonesia as a center for aesthetic bio-pharmaceuticals that integrates research and development, manufacturing, and global business operations.
The Selatox manufacturing facility is built on a 4,740 square meter land with the construction process commencing in 2022 and the main construction in 2023. This plant is specifically designed to produce botulinum toxin. The facility has a production capacity of up to 6.5 million vials per year, with a total of about 190 production batches, or around 34,500 vials per batch.
Although the facility has been inaugurated, production will only commence in 2028. Until then, the company will continue to complete the certification and a series of trials. The entire production process is supported by automated systems, from formulation, sterile filtration, aseptic filling, to the freeze-drying process. Selatox also implements a cold chain-based storage system to maintain the stability of biological products- finished products are stored at a temperature of 2-8 degrees Celsius, while the active ingredient or drug substance is maintained at an ultra-low temperature before further processing.
Selatox CEO, Joh Young Hoon, stated that the GMP certification from BPOM is a significant milestone for the company to build a globally standard production facility. "With precise production processes and strict quality management, we deliver high-quality products that can be trusted. We will also develop a biotechnology ecosystem through global research, development, and collaboration," he said.
Joh Young Hoon added that this certification confirms that their manufacturing facility and quality management system have met the established standards. "Through precise production processes and strict quality control standards, we are committed to delivering high-quality products that can be trusted by healthcare professionals and our partners," he said.
Joh Young Hoon further added that his team will continue to invest in the development of local human resources and the implementation of internationally standardized manufacturing technologies to grow together and contribute to the advancement of the pharmaceutical and biotechnology industry in Indonesia.
The development of this manufacturing facility is supported by an investment from Daewoong Group amounting to approximately Rp 4.7 trillion.
Director General of Bio-pharmaceutical Office of the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) Ahn Young-jin stated that this achievement is a significant milestone in strengthening the strategic partnership between South Korea and Indonesia in the bio-pharmaceutical and health sector. MFDS Korea and BPOM Indonesia have gained global recognition through their status as a WHO Listed Authority (WLA), reflecting the excellence of the regulatory systems of both institutions. "In the future, we will continue to strengthen bilateral regulatory cooperation to improve access to innovative bio-pharmaceutical products and support the growth of the bio-pharmaceutical industry in both countries," he said.
Special Staff to the Minister of Health for Health System Transformation, Ministry of Health of the Republic of Indonesia, Agus Tjahajana Wirakusumah, expressed that in line with the agenda of health system transformation, the government continues to push for the realization of national health resilience through strengthening domestic production capacity, mastering technology, and increasing collaboration between the government, industry, and educational institutions. "The presence of manufacturing facilities such as PT Selatox Bio Pharma is expected to support Indonesia's pharmaceutical self-sufficiency while enhancing the competitiveness of the national health industry," said Agus.
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