COMMITTED TO QUALITY

DELIVERING EXCELLENCE

Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises
Ltd with a vast network of development and manufacturing facilities located in North America, Europe and Asia.
We offer a comprehensive range of services across all the phases of the drug life cycle, which includes Drug
Discovery & Development, Manufacturing and Packaging of Clinical Trial Supplies, Delivering Commercial
Volumes of APIs and Finished Dosage forms.
Discovery Services:
Chemistry & Biology Support for Hit to Lead / Lead Optimization:
Chemistry Support for Drug Discovery Projects
Custom Synthetic Chemistry Services;
- Discrete Compounds (mg to gm)
- Focused Libraries (20-100 compounds)
In-vitro ADME/Biology, DMPK,
Toxicology and Safety Services
Pharmaceutical Development Services:
Pre-Formulation Special Capabilities
Phase I to III Clinical Development (NCEs) - Pediatric Formulations
Expertise to Handle Wide Range of Chemistries
Sterile Liquids Injectable & Ophthalmic - Oncology Molecules (Sterile and Solid Dosages)
- Including Heterocyclic, Organometallic,
- Lyophilized & Liposomal - Hormonal formulations
Peptide & Carbohydrate chemistry
- Suspensions & Depots - Taste Masking Technology
- Chiral Separation using Supercritical
Oral Solid Formulations - Depot Injections
Fluid Chromatography (SFC)
- MR, ER and Other release profiles Complete development of ANDAs / CTDs
- Bilayer & Press-Coated tablets

Process R&D services: API Generics:

Process Research and Route Scouting Aprepitant Clobazam Donepezil Hydrochloride Misoprostol
Process development & Optimization Armodafinil Dabigatran Entacapone Monosulfiram
Non-GMP and GMP manufacturing Baclofen Etexilate Mesylate Ketoconazole Oxybutynin Hydrochloride
CMC support for API from IND to NDA Bisoprolol Fumarate Diltiazem Lurasidone Hydrochloride Perindopril Erbumine
Camylofin dl-Cloprostenol Mebeverine Hydrochloride Pramipexole
Cinacalcet Sodium*
High Potency API (HPAPI) Services:
High Potency drug substance development and *Veterinary Drug
commercial manufacturing Antibody Drug Conjugates:
Full range of scale and containment options for
HPAPI manufacturing Proof of Concept studies
State-of-the-art HPAPI manufacturing suite with Process Development, Optimization & Characterization
airlocks and barrier isolation systems Clinical & Commercial manufacturing of conjugates
Multiple global regulatory manufacturing approvals - US-FDA approval for commercial manufacturing
for innovator HPAPIs, several fast track approvals - 600 clinical batches manufactured
ADC Sterile Fill / Finish
Analytical & Bio-analytical Method
Development & Validation
Clinical Trial Supply Services
Stand-alone analytical services like
Clinical Batch Manufacturing - Cell Based Assays
- Oral Solids - Stability Study Design & Execution
- Sterile Liquids
- Hormones & High Potent
Clinical Batch Packaging Commercial Manufacturing Services:
- Primary and Secondary
Manufacturing and Supply of:
- Blinding, Labelling & Randomisation
Support Services Key and Registered Starting materials
- QP services Advanced Intermediates and APIs
- Returns and Destruction Finished Dosage forms Oral Solids and
- Comparator Sourcing Sterile Injectables
http://www.piramal.com/pharmasolutions/