committed to quality - piramal pharma solutions · piramal pharma solutions is the contract...
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DELIVERING EXCELLENCE
COMMITTED TO QUALITY
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 fulfilling our
clients’ API development & manufacturing
requirements across all phases of the drug life cycle.
PROCESS DEVELOPMENT
CLINICAL TRIAL SUPPLIES OF API
ADVANCED FLOW REACTOR (AFR) CMC CONSULTING SERVICES
Process Development and Optimization for Pre-Clinical and Clinical Supplies
Pre-Clinical (GMP & non-GMP)
Process Engineering & Yield Improvement
cGMP process validations required tosupport NDA approval
Chemical, manufacturing and controldata for NDA filing
Supply cGMP materials for clinical trials
COMMERCIAL MANUFACTURING
ANALYTICAL SERVICESAnalytical method validation and method transfer
Testing of raw materials, intermediates and finished product
Stability studies as per ICH guidelines
Multiple scale-up/Pilot Facilities for non-GMP & GMP manufacturing
US FDA/UK MHRA approved plants
Forward integrated with Formulation Services
Manufacturing & supply RSM/KSMs, GMP Intermediates, phase III & commercial APIs (including High Potency APIs)
ROUTE SCOUTING SERVICES BIOCATALYSIS
Dedicated team/labs for process research
Quick turnaround of RFQ/RFPs
Flexible FTE resourcing & Tailored proposals
Unsurpassed stereo, chemo & regio-selectivity
Commercial & custom enzymes
Scale-up to multi-tonne scale
Green chemistry, reducing environmental impact
Discovering & developing optimized,competitive and cost-effective routes
Enzyme catalysis for fast track development effective and green routes
Continuous process with high throughput works well for fast chemistries Rapid scale-up, higher yields & improved purity
Lower energy consumption & reduced costs
Support for Identification of KSM/RSM
Identification of PGIs (potential genotoxic impurities)
Maintenance of global marketing licensespost-approval
Continuous flow chemistry to address batch chemistry challenges
Consulting services for CMC regulatory submissions, including INDs, NDAs, ANDAs, DMFs
Piramal Pharma Solutions
Agastya Corporate Park, Kamani Junction, Kurla (West), Mumbai 400 070. India. [email protected] | www.piramalpharmasolutions.com
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