Pharbil Waltrop (NextPharma)

Germany
Oral Solid Dose Semi-solids & Liquids
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (2) ○ MHRA GMP ✓ HC GMP (12)

Quick Facts: Pharbil Waltrop (NextPharma)

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Germany
Website
Modalities
Oral Solid Dose, Semi-solids & Liquids
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Pharbil Waltrop (NextPharma)

Pharbil Waltrop (NextPharma) is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Semi-solids & Liquids. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://nextpharma.com/en/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

Pharbil Waltrop (NextPharma) FDA Inspection History

2024-11
2024-02
NAI VAI OAI
Date Site Type Observations Classification
2024-11-19
allphamed PHARBIL Arzneimittel GmbH
Gottingen Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2024-02-07
Pharbil Waltrop Gmbh
Waltrop Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Pharbil Waltrop (NextPharma) FDA 483 Findings 2 observations · 2025-06-06 → 2025-06-06 ?

By subsystem

  • Documentation & Records 2 (100.0%)

By severity

  • 2 — Minor: 2
  • Repeat observations: 0

Most severe findings

  • Minor (2) Documentation & Records 2025-06-06 21 CFR 211.188
    Prepared for each batch, include complete information

    "Batch production and control records do not include complete information relating to the production and control of each batch."

  • Minor (2) Documentation & Records 2025-06-06 21 CFR 211.22(d)
    Procedures not in writing, fully followed

    "The responsibilities and procedures applicable to the quality control unit are not fully followed."

Pharbil Waltrop (NextPharma) EMA GMP Compliance 2 certificates

2024-02
2024-02
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
DE_NW_05_GMP_2024_0032 Pharbil Waltrop GmbH Germany 2024-02-07 COMPLIANT
DE_NW_06_GMP_2024_0008 Pharbil Waltrop GmbH Germany 2024-02-06 COMPLIANT
Source: EMA EudraGMDP · Retrieved Oct 31, 2026

Hiring Activity 4 open roles Beta

From public job postings on the parent company's careers board, as of Oct 30, 2026. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
4
open roles
3
in manufacturing, quality, PD/MSAT, engineering or regulatory (75%)
Trend from Nov 29, 2026
Tracking started Oct 30, 2026. 30-day change shows after 30 days, 90-day after Jan 28, 2027.
By function
Manufacturing & operations 3
Commercial, BD & client projects 1
By site
Waltrop
3 mfg/ops · 1 other
4
Latest postings
Verpackungsmitarbeiter Verpackungshelfer Manufacturing & operations · Waltrop
Teamleiter Verpackung Manufacturing & operations · Waltrop
Purchasing Specialist Manufacturing & operations · Waltrop
Customer Service Specialist Commercial, BD & client projects · Waltrop
Coverage: read from the parent company's careers board and kept only postings at this business's sites (group board filtered to the profile site (Waltrop)). Roles outside those sites are left out, and some of this unit's roles may be missed. Function groups come mainly from job titles (about 84% match a hand check), and modality words from titles only, so both are approximate.
Source: careers.nextpharma.com · Checked Oct 30, 2026 · Tracking since Oct 30, 2026

Frequently Asked Questions About Pharbil Waltrop (NextPharma)

How many FDA inspections does Pharbil Waltrop (NextPharma) have on record?
CDMO Signal tracks 2 FDA inspections for Pharbil Waltrop (NextPharma), sourced from the FDA inspection database. See the full inspection history above.
Has Pharbil Waltrop (NextPharma) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Pharbil Waltrop (NextPharma).
Does Pharbil Waltrop (NextPharma) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA GMP certificates for Pharbil Waltrop (NextPharma).
Does Pharbil Waltrop (NextPharma) have a CDMO Signal Score?
Not yet. Pharbil Waltrop (NextPharma) is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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