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Aenova — Ratisbon

Ratisbon, Germany · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
Aenova
Name(s) in FDA data
Haupt Pharma Amareg GmbH
FEI number(s)
3008293991 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Ratisbon, Germany
Records matched
6 FDA inspections
Most recent FDA inspection in dataset
26 Jul 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …and granules Hardcapsules Film coated tablets Semisolids Gels Creams Pastes Ointments Non sterile Liquids Solutions Suspensions OEB 1-5, incl. narcotics and hormones Quality service Development…
  • Highly potent (HPAPI)
    …ds The Aenova Group site in Regensburg with its special environment is one of the leading HPAPI development, production and packaging facilities for high potent solids: Capsules, tablet…
  • Oral solid dose
    …he leading HPAPI development, production and packaging facilities for high potent solids: Capsules, tablets and film coated tablets From small to large scale (0,5 to 500kg) Covering comple…
  • Oral liquids & semi-solids
    …Germany Competence Center high potent solids (oncology) – conventional solids - specialty semisolids & liquids The Aenova Group site in Regensburg with its special environment is one of the…
  • Clinical trial supply & packaging
    …burg with its special environment is one of the leading HPAPI development, production and packaging facilities for high potent solids: Capsules, tablets and film coated tablets From small t…
  • Formulation & process development
    …ction: 3,506 m² Packaging: 3,966 m² Goods receipt and storage: 4,200 m² Analytics: 877 m² Formulation development/ clinical trials: 200 m² FTE: 363 Shifts: 15/5 Manufacturing Services Production of Solid…

Taken from the company's web page for this site. Source: https://www.aenova-group.com/en/company/manufacturing-sites/regensburg, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 26 Jul 2024
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008293991, inspection ID 1274881)

  2. 07 Jun 2019
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008293991, inspection ID 1134674)

  3. 10 Nov 2017
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008293991, inspection ID 1038904)

  4. 26 Aug 2016
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3008293991, inspection ID 986248)

  5. 22 Nov 2013
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008293991, inspection ID 857318)

  6. 18 May 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Veterinary. Project area(s): Monitoring of Marketed Animal Drugs, Feed, and Devices; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3008293991, inspection ID 727709)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.