Piramal Pharma Solutions

Lexington, KY · Riverview, MI · Ahmedabad, IN
Biologics
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
76.4
Signal Score
✓ FDA Inspections (5) ○ Clinical Trials ○ SEC Filings ✓ Press (20) ✓ EMA GMP (1) ✓ MHRA GMP (12)

Quick Facts: Piramal Pharma Solutions

Signal Score
76.4/100 (as of 2026-04-29)
Quality Compliance
80.3/100
Headquarters
Lexington, KY · Riverview, MI · Ahmedabad, IN
Modalities
Biologics
Active Programs
No ClinicalTrials.gov matches confirmed — 7 partnership announcements in press
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

About Piramal Pharma Solutions

Indian pharma CDMO with US manufacturing.

Signal Score & Pillar Breakdown

Quality Compliance 80.3
FDA Inspections5 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2026-02-13)
EMA GMP Certificates1 on record
MHRA GMP Certificates12 on record
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer. 7 partnership announcements found in press monitoring.
Programs — no verified data
Sponsors— no verified data
ModalitiesBiologics
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 83.0
Publicly traded — financial transparency
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Publicly traded — financial transparency
Capacity 63.0
3 manufacturing sites
Strong partnership activity (7 articles)
Sites: Lexington, KY, Riverview, MI, Ahmedabad, India
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
Recent Press20 articles
3 manufacturing sites
Strong partnership activity (7 articles)

FDA Inspection History

2026-02
2025-12
2025-12
2025-05
2025-02
NAI VAI OAI
Date Site Type Observations Classification
2026-02-13 Kohir Mandal Drug Quality Assurance No Voluntary Action Indicated (VAI)
2025-12-17 Naidupeta Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2025-12-10 Lexington, Kentucky Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2025-05-30 Aurora Drug Quality Assurance No No Action Indicated (NAI)
2025-02-17 Navi Mumbai Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved May 20, 2026

FDA 483 Findings 9 observations · 2025-12-10 → 2025-12-17 ?

By subsystem

  • Documentation & Records 4 (44.4%)
  • Equipment & Facilities 2 (22.2%)
  • CAPA 2 (22.2%)
  • Data Integrity 1 (11.1%)

By severity

  • 5 — Critical: 1
  • 3 — Moderate: 2
  • 2 — Minor: 6
  • Repeat observations: 0

Most severe findings

  • Critical (5) Data Integrity 2025-12-10 21 CFR 211.68(b)
    Computer control of master formula records

    "Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."

  • Moderate (3) CAPA 2025-12-17 21 CFR 211.198(b)(2)
    Complaint Investigation/Follow-Up Findings

    "Complaint records are deficient in that they do not include the findings of the investigation and follow-up."

  • Moderate (3) CAPA 2025-12-10 21 CFR 211.192
    Investigations of discrepancies, failures

    "There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed."

About this data →

EMA GMP Compliance 1 certificates

2025-11
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
NL/H 25/2059654 Piramal Pharma Solutions (Dutch) B.V. Netherlands 2025-11-27 COMPLIANT
Source: EMA EudraGMDP · Retrieved May 20, 2026

MHRA GMP Compliance 12 certificates

2025-09
2025-09
2025-09
2025-09
2025-02
2025-02
2024-12
2024-12
2024-12
2024-02
2019-05
2019-05
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK API 29595 Insp GMP/IMP 29595/10933-0018 [H] PIRAMAL HEALTHCARE UK LIMITED GRANGEMOUTH FK3 8XG 2025-09-02 COMPLIANT
UK API 29595 Insp GMP/IMP 29595/10933-0018 [V] PIRAMAL HEALTHCARE UK LIMITED GRANGEMOUTH FK3 8XG 2025-09-02 COMPLIANT
UK MIA 29595 Insp GMP/IMP 29595/10933-0018[H] PIRAMAL HEALTHCARE UK LIMITED GRANGEMOUTH FK3 8XG 2025-09-02 COMPLIANT
UK MIA(IMP) 29595 Insp GMP/IMP 29595/10933-0018[I] PIRAMAL HEALTHCARE UK LIMITED GRANGEMOUTH FK3 8XG 2025-09-02 COMPLIANT
UK GMP 18772 Insp GMP 18772/301330-0010 [H] PIRAMAL PHARMA LIMITED IN-502 321 2025-02-05 COMPLIANT
UK GMP 18772 Insp GMP 18772/301330-0010 [V] PIRAMAL PHARMA LIMITED IN-502 321 2025-02-05 COMPLIANT
UK API 29595 Insp GMP/GDP/IMP 29595/18244-0044 PIRAMAL HEALTHCARE UK LIMITED MORPETH NE61 3YA 2024-12-23 COMPLIANT
UK MIA(IMP) 29595 Insp GMP/GDP/IMP 29595/18244-0044[I] PIRAMAL HEALTHCARE UK LIMITED MORPETH NE61 3YA 2024-12-23 COMPLIANT
UK MIA 29595 Insp GMP/GDP/IMP 29595/18244-0044[H] PIRAMAL HEALTHCARE UK LIMITED MORPETH NE61 3YA 2024-12-23 COMPLIANT
UK MIA 29595 Insp GMP 29595/36189300-0002[H] PIRAMAL HEALTHCARE UK LIMITED GRANGEMOUTH FK3 8ZF 2024-02-06 COMPLIANT
UK GMP 54023 Insp GMP 54023/301330-0009 [H] PIRAMAL PHARMA LIMITED IN-502 321 2019-05-13 COMPLIANT
UK GMP 54023 Insp GMP 54023/301330-0009 [V] PIRAMAL PHARMA LIMITED IN-502 321 2019-05-13 COMPLIANT
Source: MHRA GMDP Database · Retrieved May 20, 2026

Recent News 20 articles

regulatory 2026-04-28
Piramal Pharma Solutions appoints Gregory Judge as Director to strengthen European business - Indian Pharma Post
Piramal Pharma Solutions appoints Gregory Judge as Director to strengthen European business  Indian Pharma Post
Source →
general 2026-04-18
Piramal, Ajinomoto team on ADC development and manufacturing - megaproject.com
Piramal, Ajinomoto team on ADC development and manufacturing  Marcus Theatres
Source →
general 2026-04-17
Piramal–Ajinomoto Partner for ADC Manufacturing - Voice of Healthcare
Piramal–Ajinomoto Partner for ADC Manufacturing  Voice of Healthcare
Source →
partnership 2026-04-16
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - Big News Network.com
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing  Big News Network.com
Source →
partnership 2026-04-16
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and... - lokmattimes.com
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and...  lokmattimes.com
Source →
general 2026-04-16
Piramal, Aji Bio-Pharma Partner to Support ADC Development & Manufacturing - Contract Pharma
Piramal, Aji Bio-Pharma Partner to Support ADC Development & Manufacturing  Contract Pharma
Source →
partnership 2026-04-16
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing | Corporate - EQS News
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing | Corporate  EQS News
Source →
partnership 2026-04-16
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing | Corporate - EQS News
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing | Corporate  EQS News
Source →
partnership 2026-04-16
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - BioSpace
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing  BioSpace
Source →
partnership 2026-04-16
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - Utusan Malaysia
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing  Utusan Malaysia
Source →
partnership 2026-04-16
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - PR Newswire UK
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing  PR Newswire UK
Source →
general 2026-04-13
Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press | Corporate - EQS News
Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press | Corporate  EQS News
Source →
general 2026-03-31
Piramal Pharma Solutions commemorates 20th anniversary at Morpeth Facility with procurement of Korsch X3 - Manufacturing Chemist
Piramal Pharma Solutions commemorates 20th anniversary at Morpeth Facility with procurement of Korsch X3  Manufacturing Chemist
Source →
general 2026-03-26
Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press | Corporate - EQS News
Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press | Corporate  EQS News
Source →
general 2026-03-25
Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press - PR Newswire
Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press  PR Newswire
Source →
general 2026-03-25
Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press - Bolsamania
Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press  Bolsamania
Source →
general 2026-03-25
Piramal Pharma Solutions - AD HOC NEWS
Piramal Pharma Solutions  AD HOC NEWS
Source →
general 2026-03-25
EQS-News: Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press - boerse.de - boerse.de
EQS-News: Piramal Pharma Solutions Commemorates 20th Anniversary at Morpeth Facility with Procurement of Korsch X3 Tablet Press - boerse.de  boerse.de
Source →
general 2026-03-25
Piramal Pharma Solutions - AD HOC NEWS
Piramal Pharma Solutions  AD HOC NEWS
Source →
general 2026-03-23
Piramal Pharma Solutions Installs Korsch X3 Tablet Press at Morpeth Facility - Contract Pharma
Piramal Pharma Solutions Installs Korsch X3 Tablet Press at Morpeth Facility  Contract Pharma
Source →
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