Piramal Pharma Solutions
Lexington, KY · Riverview, MI · Ahmedabad, IN
7 partnership announcements in press monitoring
· Last scored 2026-09-07
83.3
Signal Score
✓ FDA Inspections (4)
○ Clinical Trials
○ SEC Filings
✓ Press (20)
✓ EMA GMP (1)
✓ MHRA GMP (12)
Quick Facts: Piramal Pharma Solutions
- Signal Score
- 83.3/100 (as of 2026-09-07)
- Quality Compliance
- 95.0/100
- Headquarters
- Lexington, KY · Riverview, MI · Ahmedabad, IN
- Modalities
- Biologics, ADC
- Active Programs
- Data pending
- 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
Scores are being republished.
Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance
95.0
FDA Inspections4 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, ADC
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Partnership Announcements (from press monitoring)
Financial Stability
83.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
63.0
Profile-based capacity assessment
Recent Press20 articles
Piramal Pharma Solutions FDA Inspection History
2026-02
2025-12
2025-05
2025-02
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-02-13 |
Piramal Pharma Limited
Kohir Mandal
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2025-12-10 |
Piramal Pharma Solutions Inc.
Lexington, Kentucky
Facility-linked
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-05-30 |
Piramal Healthcare (Canada) Ltd.
Aurora
Facility-linked
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-02-17 |
Piramal Pharma Limited
Navi Mumbai
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 07, 2026
Attribution not established
(1)
These records are excluded from this company’s established evidence
because their attribution is unresolved. This describes an evidence-linking
limitation, not an assessment of the underlying regulatory findings.
| Source | Establishment named by the regulator | Location | Identifier |
|---|---|---|---|
| FDA inspection | APL HEALTHCARE LIMITED | Naidupeta | FDA/FEI=3011895410 |
Source records retained verbatim · attribution not established
Piramal Pharma Solutions FDA 483 Findings 4 observations · 2025-12-10 → 2025-12-10 ?
By subsystem
By severity
- 5 — Critical: 1
- 3 — Moderate: 1
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
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."
-
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."
-
Absence of Written Procedures
"Your firm failed to establish adequate 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."
Piramal Pharma Solutions 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 Oct 07, 2026
Piramal Pharma Solutions 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 Oct 07, 2026
Recent News 20 articles
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
Piramal, Ajinomoto team on ADC development and manufacturing - megaproject.com
Piramal, Ajinomoto team on ADC development and manufacturing Marcus Theatres
Piramal–Ajinomoto Partner for ADC Manufacturing - Voice of Healthcare
Piramal–Ajinomoto Partner for ADC Manufacturing Voice of Healthcare
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
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
Piramal, Aji Bio-Pharma Partner to Support ADC Development & Manufacturing - Contract Pharma
Piramal, Aji Bio-Pharma Partner to Support ADC Development & Manufacturing Contract Pharma
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
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
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
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
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
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
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
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
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
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
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
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
Frequently Asked Questions About Piramal Pharma Solutions
How many FDA inspections does Piramal Pharma Solutions have on record?
CDMO Signal tracks 4 FDA inspections for Piramal Pharma Solutions, sourced from the FDA inspection database. See the full inspection history above.
Has Piramal Pharma Solutions received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Piramal Pharma Solutions.
Does Piramal Pharma Solutions hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 EMA and 12 MHRA GMP certificates for Piramal Pharma Solutions.
What is Piramal Pharma Solutions's CDMO Signal Score?
Piramal Pharma Solutions has a Signal Score of 83/100, based on quality, operations, financial stability, and capacity data.
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