Sinergium Biotech
Pharmaceutical formulations, generic medicines and healthcare products.
Sinergium Biotech manufactures pharmaceutical formulations, generic medicines and healthcare products from its Buenos Aires operations. The company supplies pharmacy channels, hospital buyers, healthcare distributors or export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Buenos Aires, Argentina
- Founded
- 2009
- Website
- sinergiumbiotech.com
- Categories
- Medical & Healthcare Supplies, Supplements & Wellness
- Markets
- Argentina, Brazil, Chile, Colombia
Verified facts
- domain-registered (green), checked 2026-08-12 Domain registry record
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- registered-manufacturer (green), checked 2026-08-21 Superintendencia de Regulacion Sanitaria de El Salvador, listado de productos farmaceuticos con registro sanitario vigente
Claimed certifications
- Good Manufacturing Practice
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Food supplements sold in the EU follow Directive 2002/46/EC: most member states require a notification to the national authority before the first sale. European Commission (supplements)
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)