Solara Active Pharma Sciences – Solan
Produsen API khusus yang memasok pasar teregulasi di seluruh dunia.
Solara Active Pharma Sciences, dibentuk dari divisi Strides Shasun API, memproduksi bahan aktif farmasi untuk ibuprofen, ranitidine, dan molekul khusus di lokasi Solan di Himachal Pradesh. Pabrik ini disetujui oleh USFDA dan EDQM, memasok pembuat obat generik di AS, Eropa, dan Amerika Latin.
- Type
- Manufacturer
- Location
- Solan, India
- Founded
- 2018
- Website
- solara.co.in
- Categories
- Perlengkapan Medis & Kesehatan, Bahan Kimia & Plastik
- Markets
- India, Amerika Serikat, Jerman, Jepang, 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)