CRAMS (Contract Research And Manufacturing Services) is one of the fastest growing segments in the pharmaceutical and now extended also to the fine chemical and intermediate industry. It pertains to outsourcing research services/ manufacturing products to low-cost providers with world class standards, in line with international regulatory norms like the USFDA, Australian-TGA, UKMCA, and EMEA.
Circa 1990’s the trend of Contract Manufacturing operations gained prominence. YEAR 2009 Recession ensured Multinational Chemical and pharma Companies came under intense pressure to cut costs to maintain their profitability.and Finally in the Year 2015 businesses became Exigent to the point where Contract manufacturing was the only way ahead given the extreme uncertainities in labour costs, Environment issues and backward integration criticals.
2015, the global Pharmaceutical market reached $1.11 trillion and is expected to continue growing at approx. 5.5% per annum. Our analysis estimates that the total global pharmaoutsourced manufacturing market reached $71.5bn in 2015 and is growing > 6.6% The contract manufacturing segment of global pharmaceutical outsourcing market was at 63.8% of the total outsourced market.
India,is one of the most preferred locations for outsourcing manufacturing services in India by the multinationals and global pharmaceutical companies.
MALLAK has diversified its wing in terms of rendering services as a Contract Research and Manufacturing Services (CRAMS)& Contract manufacturing operation ( CMO ) . We deliver services to our esteemed customers in 3 different aspects:
This includes a technology development which could be in form of a non-infringing pathway or a novel formulation matrix with complete validations. It also involves confidential technology transfer of the process, exclusivity depending on initial terms and conditions with the customer.
This includes in-house manufacturing of the product adhering to the transferred technology by the customer, under highly restrictive confidentiality agreement.
Complying with the requirements of the customer, we design the formulation, analytical data and stability data and further upscale it to the manufacturing scale.
Our charges for R&D are decided upon discussion with the customer. It can be an upfront development fee or a combination of development fee and as a royalty on sales of the final product. Our contract manufacturing fees are decided upon the bulk, system occupancy of the plant in terms of equipment, manpower and timeframe. We treat these projects as turn key projects, where the customer audits us time to time.
MALLAK offers comprehensive and confidential contract research and manufacturing services for products from development through to bulk production.
