As a family-owned, independent German CDMO, Solupharm Pharmazeutische Erzeugnisse GmbH manufactures sterile parenterals on behalf of its customers and is inspection-ready in accordance with the leading international pharmaceutical standards. This page provides an overview of regulatory approvals and inspections, awards, and energy and sustainability management.
Solupharm is inspection-ready in accordance with the relevant international standards for sterile pharmaceutical manufacturing. The following overview lists the most recently documented inspection or review in each case.
| Standard / Authority | Scope | Inspection / Status |
|---|---|---|
| EU-GMP (HLfGP) | Sterile medicinal products | Inspection April 2025 |
| FDA cGMP | Sterile medicinal products (US market) | Last reviewed March 2022 (via MRA with the German supervisory authority) |
| ANVISA (human medicinal products) | Brazilian market | Q1/2016 |
| ANVISA (medical devices) | Brazilian market | April 2026 |
| ANVISA (veterinary medicinal products) | Brazilian market | Darmstadt Regional Council (RP Darmstadt), July 2022 |
| EAEU | Eurasian Economic Union | Inspection 11/2024 |
In 2023, Solupharm was recognized for its collaboration as a contract manufacturer.
Solupharm operates a certified energy management system and has its sustainability performance assessed externally.
| Standard / Rating | Status |
|---|---|
| ISO 50001 (energy management) | Actively valid 15 Nov 2025 to 14 Nov 2028 |
| EcoVadis | Bronze 50/100 (as of 2023, renewal underway in 2026) |
Under FDA cGMP, EU-GMP, ANVISA and EAEU.
Yes; the FDA cGMP status was last reviewed in March 2022 via the MRA with the German supervisory authority.
Yes; Solupharm holds dedicated manufacturing authorizations for sterile medical devices and sterile veterinary medicinal products; in addition, customer-specific audits by accredited bodies are ongoing.
The Bayer Supplier Award in 2023, presented by Bayer Pharmaceuticals External Manufacturing & Partnership Management (Basel, 17 April 2023).
Solupharm is certified under ISO 50001 (valid 15 Nov 2025 to 14 Nov 2028) and rated EcoVadis Bronze (50/100, as of 2023); renewal is underway in 2026.