Daewoong Pharmaceutical, a leading South Korean biopharmaceutical company, is the manufacturer of Nabota (also known as Jeuveau® in the US), a premium botulinum toxin type A product. Nabota has gained global recognition for its efficacy in both aesthetic and therapeutic applications, competing with established brands.
In this article, we explore Daewoong Pharmaceutical’s role as the Nabota manufacturer, its FDA approval status, clinical studies, and why it stands out in the competitive botulinum toxin market.
Founded in 1945, Daewoong Pharmaceutical has evolved from a domestic drug manufacturer to an international biotech leader. The company's neurotoxin research facility in Seongnam, South Korea, represents one of Asia's most advanced biopharmaceutical production centers, featuring:
ISO 13485 certified clean rooms
Fully automated fill-finish systems
AI-powered quality control processes
This technological infrastructure enables Daewoong to produce Nabota with exceptional purity and consistency, achieving a remarkable <1% batch-to-batch variation - a standard that surpasses many industry competitors.
Nabota's journey to international acceptance was built on rigorous clinical testing. The Phase III clinical trial program involved over 2,100 participants across 71 sites worldwide, demonstrating:
89% responder rate for glabellar line treatment
Onset of action within 2-3 days (faster than some competitors)
Duration of effect averaging 4-6 months
The New England Journal of Medicine featured Daewoong's groundbreaking research on Nabota's molecular stabilization technology in 2018, highlighting its unique protein purification process that reduces antibody formation risk.
Daewoong's strategic regulatory approach has secured Nabota approvals in:
United States (FDA approval 2019 as Jeuveau®)
European Union (EMA approval 2020)
China (NMPA approval 2021)
Southeast Asia (Approved in 8 countries as of 2023)
The FDA approval process involved particularly stringent review, with Daewoong submitting over 250,000 pages of documentation and completing 27 separate facility inspections before receiving clearance.
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Since its global launch, Nabota has captured approximately 12% of the worldwide botulinum toxin market. Daewoong recently announced a $300 million expansion of its manufacturing capacity to meet growing demand, particularly in:
Therapeutic applications (chronic migraine treatment showed 72% efficacy in recent trials)
New aesthetic indications (currently in Phase III trials for masseter hypertrophy)
Emerging markets (projected 40% growth in Southeast Asia through 2025)
Yes, Nabota botulinum toxin received FDA approval for its aesthetic applications in the United States in 2019. This approval was a major milestone for Daewoong Pharmaceutical, marking the product's entry into one of the largest and most competitive botulinum toxin markets in the world. The FDA’s approval for Nabota Daewoong emphasized the product’s safety, efficacy, and consistent performance in clinical trials.
Aesthetic Use:
Glabellar lines (FDA-approved)
Forehead wrinkles & crow’s feet (off-label use)
Therapeutic Indications:
Chronic migraines
Muscle spasticity
Hyperhidrosis (excessive sweating)
Nabota is available in 100 units and 200 units vials. It is administered via intramuscular or intradermal injection by licensed medical professionals.
For medical professionals and aesthetic clinics, choosing Nabota means offering patients a safe, effective treatment option with a proven track record.
If you're looking for a high-quality botulinum toxin option, Nabota by Daewoong Pharmaceutical is an excellent choice for your clinic or spa.
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