Catalent (Novo Holdings) vs Piramal Pharma Solutions: CDMO Comparison
Side-by-side comparison of Catalent (Novo Holdings) and Piramal Pharma Solutions on independent FDA inspections, EMA and MHRA GMP certificates, clinical-program activity, and CDMO Signal Score. Data sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.
Key differences
- Piramal Pharma Solutions has more FDA inspections on record (5 vs 1) — a deeper regulatory paper trail.
- Both maintain clean enforcement records — no FDA OAI classifications or warning letters on file for either CDMO.
- Piramal Pharma Solutions holds 1 active EMA GMP certificates; Catalent (Novo Holdings) does not appear in EudraGMDP.
- Piramal Pharma Solutions maintains 12 MHRA / UK GMP certificates; Catalent (Novo Holdings) does not.
On a 13-modality CDMO landscape, both Catalent (Novo Holdings) and Piramal Pharma Solutions qualify as ADC manufacturers; Piramal Pharma Solutions carries the higher composite Signal Score for ADC programs in this comparison.
What to evaluate for ADC programs
Both Catalent (Novo Holdings) and Piramal Pharma Solutions qualify as ADC CDMOs. When choosing between them for ADC programs, weigh these four dimensions specifically — each carries through to the side-by-side scorecard above.
HPAPI containment
Look for OEB-5 (sub-microgram occupational exposure band) suites for handling cytotoxic payloads end-to-end. Containment maturity is the floor for credible commercial ADC work.
Linker-payload chemistry on file
Match the CDMO's payload + linker experience to your program. MMAE / vc-MMAE is the most common; PBDs, calicheamicin, Dxd-class topoI inhibitors, and TLR agonists each carry distinct handling and analytical demands.
Commercial bioconjugation track record
Has the CDMO conjugated a commercially-approved ADC? Track record on Polivy, Padcev, Trodelvy, Enhertu, Tivdak, Elahere, Adcetris, Mylotarg, Besponsa, Lumoxiti, Blenrep, etc. is a strong qualifying signal.
Integrated DS + DP
Bioconjugation produces ADC drug substance; you'll also need sterile fill-finish for drug product. Confirm whether the CDMO covers both or partners — both routes work, but integrated is faster on transfer.
Frequently asked: Catalent (Novo Holdings) vs Piramal Pharma Solutions
Which has the stronger FDA inspection record, Catalent (Novo Holdings) or Piramal Pharma Solutions?
Both Catalent (Novo Holdings) and Piramal Pharma Solutions maintain clean enforcement records on file — no FDA warning letters and no OAI classifications. Catalent (Novo Holdings) has 1 FDA inspection on record; Piramal Pharma Solutions has 5.
How do Catalent (Novo Holdings) and Piramal Pharma Solutions compare on European GMP coverage?
Catalent (Novo Holdings) holds 0 active EMA GMP certificates and 0 MHRA / UK certificates. Piramal Pharma Solutions holds 1 active EMA GMP certificate and 12 MHRA / UK certificates. Use these counts as a proxy for the breadth of each CDMO's European regulatory footprint.
Which is better for ADC manufacturing — Catalent (Novo Holdings) or Piramal Pharma Solutions?
Both Catalent (Novo Holdings) and Piramal Pharma Solutions are tagged as ADC CDMOs in our directory, so both are credible options for ADC programs. The most important differentiator for ADC selection is typically hpapi containment: Look for OEB-5 (sub-microgram occupational exposure band) suites for handling cytotoxic payloads end-to-end. Containment maturity is the floor for credible commercial ADC work. Review each CDMO's profile and inspection record before shortlisting.
What does the Signal Score gap mean in practice?
Catalent (Novo Holdings) carries a Signal Score of 75/100 and Piramal Pharma Solutions carries 84/100 — a small lead for Piramal Pharma Solutions. The Signal Score combines quality (FDA inspections + EMA/MHRA GMP), operational performance, financial stability, and capacity intelligence. CDMOs cannot pay to influence their score.
Use the free AI matchmaker to weigh both against your specific requirements — capacity, modality, regulatory record, geography — and surface other qualified options.
Find & compare CDMOs →