Solara Active Pharma Sciences – Solan
专业 API 制造商，为全球受监管市场供应产品。
Solara Active Pharma Sciences 由 Strides Shasun API 部门组建，在喜马偕尔邦的 Solan 工厂生产布洛芬、雷尼替丁和特种分子的活性药物成分。该工厂获得了 USFDA 和 EDQM 批准，为美国、欧洲和拉丁美洲的仿制药制造商供货。
- Type
- Manufacturer
- Location
- Solan, India
- Founded
- 2018
- Website
- solara.co.in
- Categories
- 医疗保健用品, 化学品与塑料
- Markets
- 印度, 美国, 德国, 日本, 巴西
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)