COMMITTED TO QUALITY
DELIVERING EXCELLENCE
API SERVICES
Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of
Piramal Enterprises Ltd. with a vast network of development and manufacturing facilities in
North America,Europe and Asia. We offer a vast array of services, which include Drug Discovery
& Development, Clinical Supply of API & Dosage Forms, Commercial Manufacturing & Supply of
API, KSMs, RSMs, Intermediates and Finished Dosage Forms. At Piramal, we are committed to
fulfil our clients API development & manufacturing requirements, across all phases of the drug
life cycle.
PROCESS DEVELOPMENT ANALYTICAL SERVICES
Process development and optimization Analytical method validation and method
for pre-clinical and clinical supplies transfer
Pre-clinical (GMP & non-GMP) Testing of raw materials, intermediates
manufacturing and finished product
Process engineering & Yield Stability studies as per ICH guidelines
Improvement
ROUTE SCOUTING SERVICES BIOCATALYSIS
Discovering & developing optimized, Enzyme catalysis for fast track development
CLINICAL TRIAL SUPPLIES OF API COMMERCIAL MANUFACTURING competitive and cost-effective routes effective and green routes
Dedicated team/labs for process research Unsurpassed stereo, chemo & regio-selectivity
Supply cGMP materials for clinical trials Manufacturing & supply RSM/KSMs, GMP
Intermediates, phase III & commercial APIs Quick turnaround of RFQ/RFPs Commercial & custom enzymes
cGMP process validations required to Flexible FTE resourcing & Tailored proposals Scale-up to multi-tonne scale
support NDA approval Multiple scale-up / Pilot Facilities for
non-GMP & GMP manufacturing Green chemistry reducing environmental impact
Chemical, manufacturing and control
data for NDA filing US FDA / UK MHRA approved plants
Forward integrated with formulation services
ADVANCED FLOW REACTOR (AFR) CMC CONSULTING SERVICES
Continuous flow chemistry to address Consulting services for CMC regulatory
batch chemistry challenges submissions including INDs, NDAs,
ANDAs, DMFs
Continuous process with high throughput -
works well for fast chemistries Support for Identification of KSM/RSM
Rapid scale-up, higher yields &
improved purity Identification of PGIs (potential
genotoxic impurities)
Lower energy consumption & reduced costs
Maintenance of global marketing licenses
post-approval
OUR GLOBAL PRESENCE
LEXINGTON MAHAD* PITHAMPUR
STERILE DEVELOPMENT VITAMINS & MINERALS FORMULATION
& MANUFACTURING PREMIXES MANUFACTURING
USFDA USFDA, WHO-GMP USFDA, MPA Sweden
RIVERVIEW MORPETH MUMBAI DIGWAL
HPAPI DEVELOPMENT API & FORMULATION API & FORMULATION API DEVELOPMENT
& MANUFACTURING DEVELOPMENT DEVELOPMENT & MANUFACTURING
USFDA MANUFACTURING USFDA, MHRA
USFDA, MHRA
AURORA GRANGEMOUTH AHMEDABAD ENNORE
API DEVELOPMENT ADC DEVELOPMENT DRUG DISCOVERY API DEVELOPMENT
& MANUFACTURING & MANUFACTURING & FORMULATION & MANUFACTURING
USFDA, MHRA USFDA, MHRA DEVELOPMENT
MPA Sweden
SHANGHAI
SOURCING OFFICE
Note: * Dietary Ingredients
Piramal Enterprises Limited, 247 Business Park, A - Wing, 6th floor, LBS Marg,
Vikhroli (W), Mumbai 400 083. India. Email: [email protected]
www.piramal.com/pharmasolutions
www.facebook.com/piramalpharma www.linkedin.com/company/piramal-pharma-solutions
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