Acme Formulation

Nalagarh (Himachal Pradesh), India
Oral Solid Dose Semi-solids & Liquids Sterile Fill-Finish
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ✓ MHRA GMP (1) ✓ HC GMP (12)

Quick Facts: Acme Formulation

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

About Acme Formulation

Acme Formulation is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Semi-solids & Liquids, Sterile Fill-Finish. 1 manufacturing site registered with the U.S. FDA, Health Canada and the UK MHRA. Website: https://acmegenerics.in/

Signal Score

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

Acme Formulation FDA Inspection History

2026-02
NAI VAI OAI
Date Site Type Observations Classification
2026-02-20
Acme Generics Private Limited
Solan Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Acme Formulation FDA 483 Findings 2 observations · 2026-02-20 → 2026-02-20 ?

By subsystem

  • Laboratory Controls 1 (50.0%)
  • Documentation & Records 1 (50.0%)

By severity

  • 3 — Moderate: 1
  • 2 — Minor: 1
  • Repeat observations: 0

Most severe findings

  • Moderate (3) Laboratory Controls 2026-02-20 21 CFR 211.84(d)(2)
    Testing Each Component for Conformity with Specs

    "Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality."

  • Minor (2) Documentation & Records 2026-02-20 21 CFR 211.100(a)
    Absence of Written Procedures

    "Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess."

Acme Formulation MHRA GMP Compliance 1 certificates

2018-03
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK GMP 47115 Insp GMP 47115/15730061-0003[H] IMMACULE LIFESCIENCES PRIVATE LIMITED IN 174101 2018-03-12 COMPLIANT
Source: MHRA GMDP Database · Retrieved Oct 31, 2026

Hiring Activity Beta

Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source: public careers pages · Checked Oct 30, 2026

Frequently Asked Questions About Acme Formulation

How many FDA inspections does Acme Formulation have on record?
CDMO Signal tracks 1 FDA inspection for Acme Formulation, sourced from the FDA inspection database. See the full inspection history above.
Has Acme Formulation received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Acme Formulation.
Does Acme Formulation hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 MHRA GMP certificate for Acme Formulation.
Does Acme Formulation have a CDMO Signal Score?
Not yet. Acme Formulation is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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