Zepatier is a once-daily oral medicine comprising 50mg of non-structural protein 5A (NS5A) replication complex inhibitor elbasvir and 100mg of NS3/4A protease inhibitor grazoprevir.
Piramal Healthcare is a leading provider of contract development, clinical services and commercial manufacturing to the global pharmaceutical industry. Situated in the north-east of England, Piramal offers commercial API manufacturing, pre-clinical pharmaceutical development through to Phase III supplies which can be coupled with clinical trial packaging and distribution, and finally commercial pharma manufacturing, packaging and distribution – all from the same facility.
Piramal’s site operates to the highest standards of GMP and quality with recent FDA and MHRA inspections. Providing services to over 30 companies, and more than 100 markets, the ability to integrate development and manufacturing services from the same location simplifies the customer’s supply chain. Piramal’s aim is to work with its customers in such a way that it acts as a virtual extension of the customers’ own operations.
API commercialisation services
Piramal’s commercial API capabilities support the following:
- Typical product volume range from 50kg/annum-5,000kg/annum
- Phase III manufacturing supplies
- Launch or late lifecycle products
- Up to Safebridge Band 3 (0.1µg/m³)
- A finishing facility capable of handling parenteral API
- DMF / CEP / CMC generation
- Worldwide sales of Misoprostol and Spironolactone (the latter through Pfizer PCS)
- Technology transfer and process optimisation
- MHRA and FDA approvals
Pharmaceutical development services
Piramal offers a comprehensive range of pharmaceutical development capabilities and experience:
Piramal Pharma Solutions
- Phase I solid drugs
- Material physical characterisation
- Solid dosage and powder manufacturing
- Specialist hormonal product capabilities
- Ability to handle controlled substances
- Placebo manufacture
- Clinical batch manufacture
- Analytical method development and validation
- Cleaning method development
- Stability studies to ICH requirements
- Process optimisation and validation
- IMP QP release services
- CMC, ANDA and IMPD generation
Commercial manufacturing of solid dosage forms
Piramal’s capabilities for commercial manufacturing of solid dosage forms include:
- High and low-shear granulation
- Roller compaction
- Fluid bed granulation
- Forced-air oven drying
- Fluid bed drying
- Powder blending and milling
- Dry coating
- Film coating
- High-speed blister packaging (cold form or thermoform)
- Bottle line packaging capable of handling glass and plastic containers
- MHRA and FDA approvals
- Analytical testing and ongoing stability programmes
- QP release services
Piramal offers rapid, efficient technology transfer of commercial products and a track record of client satisfaction.
Clinical trial packaging services
Piramal’s dedicated clinical trial services suite specialises in manufacturing and placebo matching for clinical trials, the design of custom solutions for the packaging and worldwide distribution of clinical trial materials, and in providing a range of associated services, including comparator sourcing, stability testing, formulation development and analytical method development. Services include:
- Drug medication sourcing
- Over-encapsulation and product blinding
- Solid dose bottling and multi-dose blistering capabilities
- Label design and printing for open and randomised studies
- Labelling and assembly of patient kits
- Translation services
- Storage and global distribution capabilities
- Real-time, fully integrated protocol tracking system
- Protocol inventory management to the patient kit level
- Post-study drug returns, reconciliation and destruction
- Full supply-chain QP declaration and certification
- Analytical method development and drug stability programmes
- Integrated global quality system, including QP presence in the UK and North America
Global contract pharmaceutical development, clinical services and commercial manufacturing services
Piramal can seamlessly integrate services across its global network of assets in North America, the UK, India and China, and provides its customers with geographical flexibility, reduction in drug development times and cost competitiveness across the product lifecycle, while maintaining high levels of service reliability and quality.
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