Directory › Aenova

Aenova — Munster

Munster, Germany · CDMO

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

Site facts

Company
Aenova
Name(s) in FDA data
Haupt Pharma Muenster GmbH
FEI number(s)
3006010798 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Munster, Germany
Records matched
5 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
20 Nov 2024 — VAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …on and packaging of low-dosed tablets and hard gelatine capsules containing highly potent APIs like hormones, hormone-related, corticoids, narcotics and other highly potent/low dosed A…
  • Highly potent (HPAPI)
    …ment, production and packaging of low-dosed tablets and hard gelatine capsules containing highly potent APIs like hormones, hormone-related, corticoids, narcotics and other highly potent/low do…
  • Oral solid dose
    …Muenster Closed containment tablet press Muenster Aenova Location Muenster, Germany Competence Center low-dosed high potent…
  • Inhalation & nasal
    …is today accompanied by production technologies for micro-dosed capsules, e.g. dry powder inhalation capsules. 250 employees 11 certifications & approvals 10,000 square meter Facts Tech…
  • Clinical trial supply & packaging
    …ules The Aenova site in Muenster has special expertise in the development, production and packaging of low-dosed tablets and hard gelatine capsules containing highly potent APIs like hormon…
  • Analytical testing
    …ment Services One stop shop from development to commercial productions Full galenical and analytical development services for all type of solids Packaging Services Tablets (blister) Tablets (bottles) Ca…
  • Controlled substances
    …h MoH Ugandan MoH ISO certificates ISO/IEC 27001:2022 ISO 50001:2018 Product Types Rx OTC Controlled Substances Address Haupt Pharma Muenster GmbH Member of the Aenova Group Schleebrüggenkamp 15 48159…

Taken from the company's web page for this site. Source: https://www.aenova-group.com/en/company/manufacturing-sites/muenster, 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. 20 Nov 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 3006010798, inspection ID 1334822)

  2. 24 Nov 2021
    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 3006010798, inspection ID 1222114)

  3. 06 Jul 2018
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 3006010798, inspection ID 1059379)

  4. 06 Jul 2018
    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 3006010798, inspection ID 1059379)

  5. 21 Mar 2014
    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 3006010798, inspection ID 875643)

  6. 30 Mar 2012
    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 3006010798, inspection ID 775211)

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.