Certifications, Approvals and Compliance

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.

Regulatory approvals and inspections

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

Dedicated manufacturing authorizations for sterile medical devices and sterile veterinary medicinal products.
Ongoing customer-specific audits by accredited bodies for medical devices.

Awards – Bayer Supplier Award 2023

In 2023, Solupharm was recognized for its collaboration as a contract manufacturer.

Energy management and sustainability

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)

Frequently asked questions on certifications and compliance

Under which standards is Solupharm inspection-ready?

Under FDA cGMP, EU-GMP, ANVISA and EAEU.

Is Solupharm qualified for the US market?

Yes; the FDA cGMP status was last reviewed in March 2022 via the MRA with the German supervisory authority.

Does Solupharm hold approvals for medical devices and veterinary medicinal products?

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.

Which award has Solupharm received?

The Bayer Supplier Award in 2023, presented by Bayer Pharmaceuticals External Manufacturing & Partnership Management (Basel, 17 April 2023).

What about energy management and sustainability?

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.

About the authors

The technical content of this page was jointly approved by the management of Solupharm Pharmazeutische Erzeugnisse GmbH.

Dr. Jürgen Gäb

Managing Director, Pharmaceutical

Pharmaceutical development, EU-GMP Annex 1, aseptic processing, regulatory strategy, sterile parenterals.

Ferdinand Seitz

Managing Director, Technical

Cleanroom technology, sterile equipment engineering, process development, pharmaceutical production, capacity planning.

Friedemann Seitz

Managing Partner

CDMO business models, strategic corporate management, family-business governance.

Thomas Zimmermann

Managing Director, Commercial

CDMO order costing, supplier management, commercial corporate management, customer operations.