Intas Pharmaceuticals

Ahmedabad, India
Cell Therapy
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
76.8
Signal Score
○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ✓ MHRA GMP (5)

Quick Facts: Intas Pharmaceuticals

Signal Score
76.8/100 (as of 2026-04-29)
Quality Compliance
100.0/100 — No FDA inspection records found for this manufacturer
Headquarters
Ahmedabad, India
Modalities
Cell Therapy
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

About Intas Pharmaceuticals

Pure-play CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
MHRA GMP Certificates5 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs — no verified data
Sponsors— no verified data
ModalitiesCell Therapy
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity 53.0
1 manufacturing site: Ahmedabad, IN
Modalities: Cell Therapy
Capacity assessment: 53.0/100
Sites: Ahmedabad, IN
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Ahmedabad, IN
Modalities: Cell Therapy
Capacity assessment: 53.0/100

Intas Pharmaceuticals FDA 483 Findings 11 observations · 2025-08-06 → 2025-12-16 ?

By subsystem

  • Documentation & Records 9 (81.8%)
  • Other 2 (18.2%)

By severity

  • 2 — Minor: 11
  • Repeat observations: 0

Most severe findings

  • Minor (2) Other 2025-12-16 21 CFR 111.165(e)
    Product received - contamination, deterioration

    "You did not hold received product under conditions that will protect against contamination, protect against deterioration and avoid mix-ups."

  • Minor (2) Documentation & Records 2025-12-16 21 CFR 111.70(e)
    Specifications - finished dietary supplement

    "You did not establish product specifications for identity, purity, strength, composition and limits on contamination."

  • Minor (2) Documentation & Records 2025-12-16 21 CFR 111.205(a)
    Master manufacturing record - prepared

    "You did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured."

About this data →

Intas Pharmaceuticals MHRA GMP Compliance 5 certificates

2025-03
2025-03
2024-02
2020-06
2018-01
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK GMP 17543 Insp GMP 17543/9621-0025 [H] INTAS PHARMACEUTICALS LIMITED IN-382210 2025-03-06 COMPLIANT
UK GMP 17543 Insp GMP 17543/9621-0025 [V] INTAS PHARMACEUTICALS LIMITED IN-382210 2025-03-06 COMPLIANT
UK GMP 17543 Insp GMP 17543/13361605-0002[H] INTAS PHARMACEUTICALS LIMITED IN 248197 2024-02-01 COMPLIANT
UK GMP 17543 Insp GMP 17543/18270974-0007[H] INTAS PHARMACEUTICALS LIMITED IN 382213 2020-06-23 COMPLIANT
UK GMP 17543 Insp GMP 17543/1682029-0005[H] INTAS PHARMACEUTICALS LIMITED IN-382213 2018-01-29 COMPLIANT
Source: MHRA GMDP Database · Retrieved Aug 22, 2026

Frequently Asked Questions About Intas Pharmaceuticals

Does Intas Pharmaceuticals hold EMA or MHRA GMP certificates?
CDMO Signal tracks 5 MHRA GMP certificates for Intas Pharmaceuticals.
What is Intas Pharmaceuticals's CDMO Signal Score?
Intas Pharmaceuticals has a Signal Score of 77/100, based on quality, operations, financial stability, and capacity data.
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