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Thai-Made Cancer Drug "IMCRANIB 400" Officially Registered by FDA
A Major Leap for Thai Healthcare! The Food and Drug Administration (FDA) of Thailand has officially approved the registration of "IMCRANIB 400," an oral targeted therapy cancer medication manufactured by the Chulabhorn Royal Pharmaceutical Manufacturing Facility under the Chulabhorn Royal Academy (CRA). This newly approved dosage strength marks a significant milestone in strengthening national drug security, expanding access to high-cost medications, and elevating the quality of life for cancer patients nationwide in accordance with the Royal Initiative.
On May 20, 2026, at the Food and Drug Administration office, Pharmacist Supatra Boonserm, Secretary-General of the FDA, honorably presented the Drug Registration Certificate for "IMCRANIB 400" to Dr. Watchara Kanjanakawinkul, Pharm.D., Director of the Chulabhorn Royal Pharmaceutical Manufacturing Facility, and the delegation from the Chulabhorn Royal Academy.
This regulatory approval represents a monumental success in fulfilling the royal vision of Professor Dr. HRH Princess Chulabhorn Krom Phra Srisavangavadhana, President of the Chulabhorn Royal Academy. Driven by her profound expertise in medical science and pharmacology, Her Royal Highness has consistently championed medical research and its scaling into industrial-level production. In 2020, she established the Chulabhorn Royal Pharmaceutical Manufacturing Facility located at Phimanmas Royal Residence, Sattahip District, Chonburi Province, to complete Thailand's medical and pharmaceutical research ecosystem. This initiative aims to reduce the country’s reliance on expensive imported drugs and eliminate financial barriers for cancer patients.
IMCRANIB 400 builds upon the success of "IMCRANIB 100" (100 mg), which made history in 2025 as the first domestically manufactured targeted cancer therapy approved in Thailand. IMCRANIB 400 contains the active pharmaceutical ingredient Imatinib at a strength of 400 mg. It is indicated for the treatment of multiple types of cancer, under the diagnosis and supervision of specialized physicians, including: Chronic Myeloid Leukemia (CML) , Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) , Gastrointestinal Stromal Tumors (GIST) and Dermatofibrosarcoma Protuberans (DFSP) — a rare type of skin cancer
The development of the 400 mg strength significantly improves patient convenience. Instead of taking multiple 100 mg tablets at a time, patients now require only one tablet per dose. This advancement drastically enhances patient compliance and reduces the likelihood of missed doses. Manufactured using state-of-the-art technology compliant with international GMDP PIC/S standards at the facility in Chonburi, patients can be fully confident in the drug's safety, quality, and efficacy, which are equivalent to imported counterparts.
Moving forward, the Chulabhorn Royal Academy remains dedicated to driving research and development to elevate Thailand’s pharmaceutical manufacturing capabilities. The academy aims to produce other cancer therapies and high-value medications, ensuring equal access to innovative healthcare and a better quality of life for all Thai citizens, reflecting the benevolent royal grace extended to the nation.
For more information, please visit the Chulabhorn Royal Academy website at https://www.cra.ac.th
