Solara Active Pharma Sciences – Solan
Fabricante especializado de APIs que fornece mercados regulamentados em todo o mundo.
A Solara Active Pharma Sciences, formada a partir da divisão Strides Shasun API, fabrica ingredientes farmacêuticos ativos para ibuprofeno, ranitidina e moléculas especiais em sua unidade Solan em Himachal Pradesh. A fábrica é aprovada pelo USFDA e EDQM, fornecendo fabricantes de medicamentos genéricos nos EUA, Europa e América Latina.
- Type
- Manufacturer
- Location
- Solan, India
- Founded
- 2018
- Website
- solara.co.in
- Categories
- Suprimentos médicos e de saúde, Produtos químicos e plásticos
- Markets
- Índia, Estados Unidos, Alemanha, Japão, Brasil
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
Claimed certifications
- FDA Registered FDA Establishment Registration
- Good Manufacturing Practice
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- 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)
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)