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

Supply cGMP materials for clinical trials
cGMP process validations required to
support NDA approval
Chemical, manufacturing and control
data for NDA filing
Dedicated team/labs for process research Unsurpassed stereo, chemo & regio-selectivity
Manufacturing & supply RSM/KSMs, GMP
Intermediates, phase III & commercial APIs Quick turnaround of RFQ/RFPs Commercial & custom enzymes
Flexible FTE resourcing & Tailored proposals Scale-up to multi-tonne scale
Multiple scale-up / Pilot Facilities for
non-GMP & GMP manufacturing Green chemistry reducing environmental impact
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
Continuous process with high throughput -
works well for fast chemistries
Rapid scale-up, higher yields &
improved purity
Lower energy consumption & reduced costs
submissions including INDs, NDAs,
ANDAs, DMFs
Support for Identification of KSM/RSM
Identification of PGIs (potential
genotoxic impurities)
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: contactus@piramal.com
www.piramal.com/pharmasolutions

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