Solara Active Pharma Sciences – Solan
Gespecialiseerde API-fabrikant die wereldwijd aan gereguleerde markten levert.
Solara Active Pharma Sciences, ontstaan uit de Strides Shasun API-divisie, produceert actieve farmaceutische ingrediënten voor ibuprofen, ranitidine en speciale moleculen op de Solan-locatie in Himachal Pradesh. De fabriek is goedgekeurd door de USFDA en EDQM en levert aan producenten van generieke geneesmiddelen in de VS, Europa en Latijns-Amerika.
- Type
- Manufacturer
- Location
- Solan, India
- Founded
- 2018
- Website
- solara.co.in
- Categories
- Medische en gezondheidszorgbenodigdheden, Chemicaliën en kunststoffen
- Markets
- India, Verenigde Staten, Duitsland, Japan, Brazilië
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)