Piramal Pharma Solutions is a contract developer and manufacturer for the entire drug lifecycle, from initial idea to commercial production.
The company offers an integrated service for new and generic drug products using a comprehensive range of advanced technologies.
Piramal Pharma Solutions has a number of research and development (R&D) programmes, and its centres and manufacturing sites are accredited by regulatory authorities in the US, Europe and Asia.
Contract research and discovery services for pharmaceutical providers
Piramal Pharma Solutions performs contract research services at its facility in Ahmedabad, India. This research centre is located in a special economic zone (SEZ), which ensures faster customs clearance for pharmaceuticals.
Under an effective drug delivery model, the company’s project managers assess and manage early development processes to create high-quality drug-like compounds.
The facility also delivers flexible research solutions such as medicinal chemistry, analytical support and laboratory services, as well as in-vitro absorption, distribution, metabolism and excretion (ADME).
Chemistry and biology support for drug discovery
Piramal Pharma Solutions offers a range of chemistry and biology support for lead and hit-to-lead optimisation in drug discovery.
The company handles a wide range of chemistries, including heterocyclic, organometallic, peptide and carbohydrate chemistry, as well as chiral separation using supercritical fluid chromatography (SFC).
Toxicology and safety services are also available, in addition to drug metabolism and pharmacokinetics (DMPK) and custom synthetic chemistry services of discrete compounds.
Process R&D services
Priamal Pharma Solutions’ process R&D services include process development and optimisation, research and route scouting, as well as good manufacturing practice (GMP) production.
Manufacturing and control (CMC) support is also available for active pharmaceutical ingredients (API).
High-potency API services
Priamal Pharma Solutions provides development and commercial manufacturing for high-potency drug substances, including a wide range of scale and containment options.
The firm’s state-of-the-art high-potency API (HPAPI) manufacturing facility collaborates closely with clients to identify generic opportunities to support timely market entry.
Piramal Pharma Solution has a portfolio of around 35 ready-to-use APIs with applications such as therapies for the central nervous system (CNS), anti-infectives and anti-diabetics. They are available with drug master files (DMF) and other regulatory documentation.
Clinical trial supply services
Piramal Pharma Solutions offers a wide range of clinical trial supply services, including:
- Clinical batch manufacturing for oral solids, sterile liquids and hormones
- Clinical batch packaging for primary and secondary packs
- Blinding, labelling and randomisation services
- Qualified Person (QP) services
- Returns and destruction processes
- Comparator sourcing
Contract pharmaceutical development services
Piramal Pharma Solutions addresses drug development challenges and ensures drug trial candidates meet stringent pharmaceutical regulatory requirements.
The company utilises its experienced R&D teams to commercialise products and optimise molecular forms and therapeutic profiles.
The firm’s pharmaceutical development services include:
- Pre-formulation development
- Phase I, II and III clinical development of new chemical entities (NCE)
- Sterile liquid production, including injectables and ophthalmic suspensions
- Oral solid formulations in modified release (MR) and extended release (ER) profiles
- Paediatric formulations
- Oncology molecules (sterile and solid dosage)
- Hormonal formulations
- Taste-masking technology
- Depot injections
Contract manufacturing services
Piramal Pharma Solutions offers contract manufacturing services for key and registered starting materials, solid dose forms, API and drug intermediates in the US, Europe and India.
The company has extensive experience in handling complex technology transfers for scale-up batches.
Piramal Pharma Solutions delivers customer-centric solutions in the field of antibody-drug conjugates (ADC).
Its world-class facilities in the UK and the US offer integrated services ranging from conjugation development to clinical and commercial ADC GMP batch manufacturing and fill/finish.