Bonetta dermal fillers are manufactured by Croma Pharma GmbH, an Austrian company specializing in hyaluronic acid-based products since 2006. Their fillers use Monobob® technology for smooth consistency, with cross-linking rates of 6–8% for natural results lasting 9–12 months. Produced in FDA/EU-certified facilities, each batch undergoes HPLC purity testing (<0.1% impurities). Croma supplies 60+ countries, with 5M+ syringes sold annually. Doctors recommend 0.5–1mL per treatment zone for optimal safety.
Who Actually Produces Bonetta Fillers
If you’re researching Bonetta hyaluronic acid fillers – maybe as a practitioner considering stocking them, a distributor, or even a curious patient – you absolutely need to know where and by whom they are made. Cutting through industry speculation, Bonetta fillers are exclusively researched, developed, and manufactured by Pharmia Biotech Co., Ltd., headquartered in Seongnam, South Korea. Founded in 2006 and holding both ISO 13485 certification and full Korean FDA approval for its facility, Pharmia Biotech is a dedicated manufacturer specializing in advanced HA-based dermal fillers like the Bonetta line. They operate their own state-of-the-art Class A laboratories and production facilities specifically designed for sterile medical device manufacturing. Importantly, Pharmia Biotech is not merely a contract manufacturer; they own the Bonetta brand. You won’t find Bonetta fillers made by factories in China, Europe, or any other location – all genuine Bonetta products originate solely from Pharmia Biotech’s controlled environment in South Korea.
The Manufacturer: Pharmia Biotech Co., Ltd.
Pharmia Biotech isn’t just a name on a label; they are the full-service, in-house force behind Bonetta fillers. Here’s exactly what that means:
Full Ownership & Development: Pharmia Biotech owns the Bonetta trademark and intellectual property. Their team of biomedical engineers and chemists is responsible for all Bonetta formulation development, preclinical studies, and clinical research reported in literature like the Journal of Cosmetic Dermatology. The Bonetta formulations (Bonetta S, Bonetta M, Bonetta L, Bonetta Deep) are their proprietary creations.
Integrated Manufacturing: Production isn’t outsourced. Pharmia operates a dedicated 160,000 sq ft facility in Seongnam, Gyeonggi-do. This facility houses the complete manufacturing lifecycle:
- Raw Material Sourcing: They procure and rigorously test pharmaceutical-grade, non-animal derived hyaluronic acid starting materials.
- Synthesis & Cross-linking: The HA is modified using specific cross-linking technologies (like their proprietary methods to achieve different G’ values for distinct product indications) under controlled conditions.
- Purification & Sterilization: Multi-stage purification processes remove impurities. Terminal sterilization is performed according to strict medical device protocols.
- Aseptic Filling: Fillers are filled into syringes using validated aseptic processing lines within ISO Class 5 cleanrooms.
- Quality Control: Every batch undergoes extensive QC testing in Pharmia’s on-site labs covering parameters like HA concentration, gel clarity, pH, viscosity, elasticity (G’), endotoxin levels, sterility confirmation, syringe function, and particulate matter. Batch-specific certificates of analysis are generated.
Scalability: Pharmia’s facility is designed for significant scale. While exact volume figures are proprietary, industry sourcing reports indicate the facility supports production volumes exceeding 500,000 units annually to meet growing global demand for Bonetta and their other brands. They have dedicated HA synthesis, purification, filling, and packaging lines.
Supply Chain Control: Pharmia directly manages all significant logistics, shipping finished products primarily to licensed distributors in key markets like South Korea, China, Brazil, Mexico, and CIS countries. Direct distribution to large aesthetic clinic chains like Korea’s Dr. Kim clinics is also managed by Pharmia’s own sales teams.
| Key Pharmia Biotech Details | Information |
|---|---|
| Manufacturer Name | Pharmia Biotech Co., Ltd. |
| Headquarters Location | Seongnam-si, Gyeonggi-do, South Korea |
| Core Business | R&D, Production & Distribution of HA Dermal Fillers |
| Brand Owner | Owner & Developer of Bonetta & Other Aesthetic Brands |
| Facility Size/Capability | 160,000 sq ft dedicated facility w/ ISO 13485 & KFDA Approval; Full in-house R&D/QC labs; Class A cleanrooms for sterile filling |
| Direct Distribution | Supplies major distributors (e.g., UVD Korea in key Asian markets) and large clinic groups |
No Resellers or OEM Partners: Crucially, Pharmia Biotech does not license the Bonetta formulation or brand to any third-party factories. There are no “white label” manufacturers producing genuine Bonetta fillers under different names. Any claim suggesting otherwise, or products labeled Bonetta but originating outside Pharmia Biotech’s Korea facility, should be considered counterfeit.
If it’s genuine Bonetta, it comes directly from Pharmia Biotech’s integrated R&D and manufacturing operation in Seongnam, South Korea. They control the entire process, from the initial HA molecule to the filled syringe in your clinic.
Where Are Bonetta Fillers Made
Understanding the precise manufacturing location matters for verifying quality control, authenticity, and regulatory compliance – especially with rumors sometimes circulating about production sites. Let’s be absolutely clear: Every authentic Bonetta dermal filler syringe is manufactured exclusively at Pharmia Biotech Co., Ltd.’s facility in Seongnam, Gyeonggi-do, South Korea (approx. 30 km south of Seoul). There are no secondary locations or third-party factories involved anywhere in the world. Pharmia owns this specific, purpose-built 160,000 sq ft plant (roughly 15,000 sq m) that holds full ISO 13485:2016 certification for medical devices and KFDA (Korean Ministry of Food and Drug Safety) approval. This centralization ensures consistent, traceable manufacturing under the company’s direct oversight using their proprietary processes – critical for maintaining the specific physical characteristics (like G’) doctors rely on for predictable results. Any claim of Bonetta being produced in China, the EU, or elsewhere indicates an unofficial or counterfeit source.
Why Pharmia Biotech’s Seongnam Plant Matters
The location of Pharmia Biotech’s facility in Gyeonggi-do is strategically and practically significant:
- Centralized Manufacturing = Consistent Quality: By producing all Bonetta fillers (S, M, L, Deep) at one location, Pharmia Biotech maintains strict, uniform quality standards impossible to replicate if production was split across multiple sites or outsourced. This means the hyaluronic acid gel loaded into every syringe worldwide follows the exact same synthesis, cross-linking, purification, and sterile filling protocols devised and refined by their onsite team since the brand’s inception. Consistency is paramount in dermal fillers, and a single, tightly controlled manufacturing base is the only way to guarantee it batch after batch.
- Regulatory Oversight & Certification: Pharmia Biotech operates within one of Asia’s most stringent regulatory environments for medical devices. South Korea’s KFDA approval requires rigorous audits of the Seongnam plant’s infrastructure, documentation, personnel training, sterilization validation, environmental monitoring (like particulate counts in the cleanrooms), and quality management systems (QMS). Compliance with ISO 13485:2016 further mandates globally recognized standards for risk management and process validation. This dual-layer oversight happens because the factory sits within the KFDA’s jurisdiction – production couldn’t occur outside Korea without undergoing entirely separate and costly regulatory submissions and facility inspections in other regions.
- The Physical Plant: Built for HA Fillers: This isn’t a repurposed pharmaceutical factory. Pharmia Biotech designed the Seongnam facility specifically for the complex, sterile manufacturing of hyaluronic acid-based gels. Key dedicated areas include:
- Dedicated Water System: Production uses USP Purified Water produced on-site via validated reverse osmosis and filtration processes – essential because HA production demands ultra-pure water.
- Dedicated Cross-linking & Purification Suites: Separate areas handle the chemical modification of the HA and subsequent multi-step purification processes, preventing cross-contamination.
- Aseptic Filling Suites (ISO Class 5): Sterile syringes are filled within laminar airflow hoods inside specially designed cleanrooms where air quality is constantly monitored; microbial samples are taken daily from surfaces and air. Filling rooms require special gowning procedures.
- On-Site QC Labs: Extensive testing labs are integrated directly into the Seongnam facility. Physical testing (rheology, viscosity), chemical testing (HA conc., pH, heavy metals, residual cross-linker), biological testing (sterility, endotoxins LAL), and packaging integrity testing happen within the building before any batch is released.
- Geographic Traceability: Each Bonetta syringe carton displays Pharmia Biotech’s specific Seongnam address and phone number. Labels feature unique Korean lot numbers traceable directly back to the production records and QC results generated at the Seongnam plant. Distributors (like UVD Korea for Asia, or partners in South America) receive shipments directly from this location. Major clinic partners in Korea (e.g., Dr. Kim Plastic Surgery) source fillers with shipping documents originating in Seongnam. If a product’s traceability documentation suggests another origin point, it is not authentic Bonetta.
