Contract Research & Manufacturing Services
Shasun has over 35 years experience providing custom development and manufacturing services to the global pharmaceutical industry offering state-of-the-art facilities, proprietary technologies and highly experienced people, we have a proven track record in the supply of chemistry and analytical services across the entire product lifecycle, from grams to tonnes, from pre-clinical to supply and manufacturing.
Our integrated service offering provides a unique approach to drug substance development and industrialisation. Utilising our dedicated Project Management structure to bring together HSE, Quality, Production and Engineering expertise, along with our highly skilled team of scientists, Shasun can offer right-first-time process development to deliver efficient, innovative processes that are scalable, environmentally sustainable and cost effective from the outset.
At Shasun we believe that we differentiate through our people and the way we do business and have the skills, competence and passion to ensure success. Why not take advantage of our expertise, experience and passion, and let us help you accelerate your product to market?
Shasun possesses an extensive array of chemistry service capabilities with world class capability in servicing the needs of global bioscience customers.
This capability includes:
- cGMP Kilo Lab facilities at 10, 20, 25 and 50L for Clinical and Commercial API Supply
- High Potency Capability at 10 and 20L
- Full range of supporting analytical services
- Validation support services (DOE, QbD)
- Multi block reactors, process intensification
- Crystallisation capabilities (control and measurement e.g. Lasentec)
- REACTIR FT-IR real time process analytical capability
- Proprietary Technology Development Capabilities
- World Class Hazard Evaluation Lab
- Expertise in Technology Transfer, Process Development and Industrialisation
- Links in to an international and well respected Scientific Advisory Board
- Comprehensive network of third party technology providers in new and emerging chemistry processing capabilities
The Shasun analytical capability is extensive and well respected within the Bioscience industry. This capability includes:
- Experienced organisation with balance of PhD, MSc and BSc analytical chemists
- Range of experience from 5 to 30 years in analytical services
- Common analytical platforms across all sites, to facilitate technology transfer between internal and external customers
- Extensive analytical method development, qualification and validation capabilities
- Structural elucidation competencies using a range of advanced techniques including absolute configuration, polymorphism, particle size analysis and solubility determination
- Extensive salt screening capabilities and rigorous protocols
- Specification development and justification
- Impurity marker and reference standard preparation, qualification, management and distribution
- Stability and forced degradation studies
- Routine support for development and manufacturing activities
- cGMP analysis of raw materials, in-process samples, intermediates, and finished products
- Analytical support for investigations
From our state-of-the-art facility in Puducherry, India, Shasun offers a comprehensive range of Formulation development and manufacturing services for solid dosage products to our pharmaceutical customers around the world. Click here for more details on our Puducherry site
The purpose built facility includes cGMP (current good manufacturing practice) pilot plant and commercial manufacturing equipment which is MHRA (Medicines and Healthcare products Regulatory Agency), PDMA (Prescription Drug Marketing Act), Health Canada and US FDA approved (Food and Drug Administration), with annual capacities of over 3 billion tablets and over 120 million capsules.
Drawing upon the expertise of our dedicated Project Managers and Scientists, Shasun has a demonstrated track record in providing services which include formulation research and development, analytical method development and validation, scale-up, technology transfer, clinical supplies and full scale commercial manufacturing of oral solid dosage forms.
Shasun recognizes the role of biotechnology as the future of the global pharmaceutical industry in enhancing therapeutic effectiveness, improving lifestyle quality and strengthening corporate profitability. In view of this, the company is involved in the creation of significant biotechnology capabilities and capacities especially in the area of protein processing solutions to provide services for the biotech and pharmaceutical companies
Protein Process Solutions and Service Offering
- Microbial fermentation process optimization and manufacturing
- Protein purification process development and manufacturing
- Bioanalytical method development, protein purity profiling and stability tstudy
- Thoroughly documented tech packages with validated process and analytical procedures
- Recombinant proteins and complete process technology packages
- Preclinical supplies
- cGMP clinical supplies
- Analytical services and reference standards
- Experienced project management with technical lead support
Robust and effective Supply Chain management is a fundamental component of any successful API service provider, ensuring that raw material components can be sourced, assembled, processed and product dispatched to our customers in an efficient, economic and compliant manner.
Shasun operates an integrated approach to Supply Chain management, with all our key activities and cGMP procedures being brought together and driven through our validated SAP business system, providing a fully compliant and robust approach to production planning.
From delivering value to our customers through the sourcing of diverse starting materials from emerging markets, to the management of the complex logistics requirements of shipping API and Hazardous Goods around the world, the Shasun team brings expertise, experience and total customer service in every area.
At Shasun we believe that we differentiate through our people and the way we do business and have the skills, competence and passion to ensure success.
Active Pharmaceutical Ingredient
With our network of API and formulation facilities at Shasun we can support our customers through the entire life cycle of a product, from clinical development and early commercial requirements, right through patent expiry and into off patent supply, allowing our customers’ products to remain competitive for longer in the market place.
- Shasun is a preferred partner in the supply chain for many APIs for our pharmaceutical customers around the world, offering a broad portfolio of over twenty APIs and excipients, many of which are developed and launched in collaboration with the originator companies.
- As well as being recognised as one of the leaders in the manufacture and supply of Ibuprofen and Ibuprofen derivatives, Shasun offers a range of products in the areas of Pain management, Anti Ulcerants and CNS.
- Our dedicated cGMP (current good manufacturing practice) development and manufacturing facilities in UK and India are US FDA (Food and Drug Administration) , MHRA (Medicines and Healthcare products Regulatory Agency),, Health Canada and PMDA (Prescription Drug Marketing Act) approved. This, coupled with an integrated logistics network to facilitate rapid product delivery to our clients’ global network means that assurance of supply is given, and with a diverse asset base Shasun can offer the most cost effective solutions for your API requirements.
At Shasun, we believe that effective Project Management is key to a successful program, aligning expertise from every discipline to ensure complete success and total customer satisfaction within every project no matter how big or how small.
With dedicated teams, Shasun has the unique ability to manage complexity through our global Project Management expertise.
Our dedicated team of Project Managers has an average of over 20 years experience in API (Active Pharmaceutical Ingredients) development and commercialisation and take ownership of every project, from the initial enquiry and evaluation all the way through technology transfer and development to routine commercial supply, ensuring continuity and knowledge retention.
- Delivering the objectives to exceed customer expectations
- Driving progress to agreed milestones
- Communication and reporting management
- Risk identification and mitigation
- Customer satisfaction and ease of doing business
Our collaborative approach to Project Management provides our customers with complete visibility of progress and the total involvement that you would expect for your project, every step of the way.
The biological treatment plant at the Dudley site is integrated with the sites manufacturing facilities to provide a seamless system for the safe continuous treatment of process waste waters. All manufacturing processes are subject to environmental assessment as part of the new product introduction system to ensure that the use of the onsite treatment facility is maximized. This minimizes both the environmental burden associated with the transportation and disposal of waste at alternative facilities as well as a cost effective solution for our customers.