About Us
Your resource for reliable Nabota information
Nabota USA is dedicated to providing clear, accessible information about Nabota botulinum toxin type A, its product presentations, specifications, professional-use information and manufacturer background.
Our goal is to make it easier for healthcare professionals, aesthetic clinics, distributors and qualified buyers to understand the different Nabota presentations and find relevant product information in one place.
Nabota is manufactured by Daewoong Pharmaceutical Co., Ltd., a pharmaceutical company headquartered in the Republic of Korea. The company identifies Nabota as one of its biologic products and describes its proprietary HI-PURE technology as part of the product’s manufacturing process.
Our commitment to product information
Nabota USA aims to provide product information that is:
- 01
Accurate
We prioritize manufacturer documentation and regulatory information when presenting product specifications.
- 02
Clear
Medical product information can be technical. Our goal is to organize essential details into straightforward sections that are easy to navigate.
- 03
Professional
Nabota is a medical product. Our website content is designed for professional and informational purposes and does not replace prescribing information, professional training or medical judgment.
- 04
Market-aware
Regulatory approvals differ by country. A product presentation or indication available in one market may not be authorized in another.
History of Nabota
Daewoong Pharmaceutical is a South Korean pharmaceutical company with a portfolio covering prescription medicines, biologics and other healthcare products.
Nabota is Daewoong’s botulinum toxin type A product. The company describes Nabota as a product developed using its proprietary purification technology, HI-PURE technology, and has expanded its regulatory and commercial presence across international markets.
Milestones and approvals
- Korea
MFDS approval for glabellar lines
- Korea
Launch in Korea
- Korea
Approval for post-stroke upper limb spasticity
- International
US FDA accepts the Biologics License Application for review
- International
US FDA cGMP approval
- International
EMA GMP approval
- International
Health Canada approval, as Nuceiva
- Korea
Approval for crow’s feet lines
- International
US FDA approval, as Jeuveau
- Korea
Approval for essential blepharospasm
- International
EMA approval, as Nuceiva
- Korea
World’s first approved indication for benign masseteric hypertrophy
- 10 years
Anniversary of the first product launch in Korea
The manufacturing process of Nabota
- 1Cultivation
- 2PrecipitationRemoves impurities
- 3PurificationTwo steps; only 900 kDa complexes are collected
- 4Formulation
- 5DryingVacuum dried, without freezing
Daewoong Pharmaceutical manufactures Nabota with a patented purification technology and vacuum drying process for a more stable and potent botulinum toxin. As a result, Nabota is produced as a high-purity 900 kDa toxin solution. It also became the first Asian botulinum toxin product to be approved by the US FDA, containing more than 98% 900 kDa complex.
Additionally, HI-PURE technology specifically removes impurities through precipitation and a two-step purification process, and separately collects only 900 kDa complexes, to produce a high-purity toxin with more than 98% of 900 kDa complexes.
>98%900 kDa complex
| 900 kDa detection area | more than 98% |
|---|---|
| Peak | a single sharp peak at about 9 minutes |
| Detection window | about 7.7 to 10.8 minutes |
Vacuum drying without freezing
Following the purification of Nabota comes the drying process, resulting in a more stable formulation, ready for distribution and reconstitution before injection. Nabota is produced by vacuum drying without a freezing process, which does not form nuclei during the process, reducing the possibility of inactive toxin. Through vacuum drying, Nabota avoids the possibility of inducing immunogenicity or adverse reactions upon administration.
Currently, all units of Nabota are developed through the vacuum drying process, except for the 150-unit vial.
How ice nucleation increases the possibility of inactive toxin formation
- Nuclei are formed in the process of freezing
- Induce structural deformation of protein (denaturation)A highly porous structure* increases exposure of protein to interfaces
- Degradation of protein activity and stability
- Possibility of inducing inactive toxin†
Safety and efficacy of Nabota
Under the developmental name DWP-450, Nabota has undergone several clinical trials proving its safety and efficacy for various conditions, such as glabellar frown lines, post-stroke upper limb spasticity, square jaw and shoulder pain syndrome.
The results, including glabellar line improvement within 2 days and the incidence of neutralizing antibodies, are set out with the published phase 3 studies on the Clinical Studies page.
Frequently asked questions
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Is Nabota approved in the United States?
Yes. Nabota is the first Asian botulinum toxin with a 900 kDa complex to be approved by the US FDA. However, the regulatory status of a specific Nabota product must be checked against current US FDA records and the exact product presentation. Approval in another country does not automatically establish US authorization.
Where is Nabota manufactured?
Nabota is manufactured by Daewoong Pharmaceutical in the Republic of Korea.
What is the active ingredient in Nabota?
The active ingredient is botulinum toxin type A. In the US, where it is approved as Jeuveau, it is named prabotulinumtoxinA.
What Nabota strengths are officially listed?
Daewoong’s current official product page lists 50U, 100U and 200U Nabota presentations. In some regions, a 150-unit vial is also available.
Are Nabota units interchangeable with Botox units?
No. Botulinum toxin products have product-specific potency assays. Nabota’s prescribing information states that its units are specific to Nabota and are not interchangeable with units of other botulinum toxin preparations.
Does Nabota require refrigeration?
Yes. Current product information specifies refrigerated storage at 2–8 °C for unopened Nabota. The product should not be frozen.
How long can reconstituted Nabota be stored?
Current product information states that reconstituted Nabota can be stored refrigerated at 2–8 °C for up to 24 hours. Always follow the current product information supplied with the specific product and market.
Can Nabota be used at home?
No. Nabota is a prescription, professional medical product and should be administered by an appropriately qualified healthcare professional.
Can the same dosage be used for every patient?
No. Treatment plans must be individualized by a qualified healthcare professional according to the indication, treatment area, patient factors and approved product information.
Can Nabota be mixed with another botulinum toxin?
Products should not be mixed or substituted unless specifically permitted by the applicable product information and appropriate professional guidance.
Order Nabota through Nabota USA
Request pricing or send a purchasing inquiry for Nabota 50U, 100U, 150U or 200U, or ask about availability, specifications and professional-use information.