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Fast-track Formulation Services for Commercial Success

DFE Pharma opens its new Center of Excellence to help pharmaceutical companies achieve ‘first-time right’ formulations

Anil kumar S Gandhi, Director, Closer to the Formulator Center Excellence, DFE Pharma

DFE Pharma, a global leader in (bio) pharma- and nutraceutical excipient solutions, opens its new Center of Excellence “Closer to the Formulator” (C2F) in Hyderabad, India. The C2F center helps pharmaceutical companies to shorten the time from a concept to a finished commercial product through expertise in all phases of pharmaceutical development.

As the pharmaceutical landscape gets more competitive, speed-of-launch and first-time-right formulation development are key to achieving successful launches of new medicines, while decreasing the related expenditure. Reducing cost and time of development can also allow affordable and new medicines to reach more patients, as many national and regional policies aimed to, like the Jan Aushadi initiative in India or the EU pharmaceutical strategy.

At DFE Pharma, we develop, produce and supply globally high-quality excipients for use in the pharmaceutical, biopharmaceutical, and nutraceutical industries. Our solutions are used for respiratory, oral solid dosage (OSD), ophthalmic and parenteral formulations, including COVID-19 vaccines and treatments. We can leverage our more than a century of expertise, to contribute to improving the formulation process of medicines and nutraceutical products.

Focused on this goal -supporting pharmaceutical companies to accelerate the time from product concept to commercial success by developing complex oral solid dosage formulations efficiently-, DFE Pharma has recently opened its new Center of Excellence called Closer to the Formulator (C2F). This center serves to enhance industry capabilities in excipient selection and formulation design, in line with the FDA’s ‘Quality-by-Design’(QbD) mindset of integrating expertise and quality into a product from the very start.

Located in Hyderabad, India, these innovative facilities are equipped with the latest technology for full range OSD formulation development and staffed by experienced scientists. The capabilities offered through the C2Fcenter can help to get faster access to the market with high-quality products and robust formulations, increased success rates, and improved efficiency. These advantages lead to a significantly reduced number of development assays and therefore lower formulation costs when launching a new product.

The services offered through this new Center of Excellence by DFE Pharma comprise all types of pre-registration work including development, scale-up, and technology transfer. Our formulation development support provides advice on excipient choice, ratio, and processing, to ensure optimum flow and compressibility, as well as stability studies when needed. The scope of the Closer to the Formulator center is focused on oral solid dosage forms, such as immediate- release tablets, chewable tablets, capsules, powders, granules, etc. It also includes specialized dosage forms like orally disintegrating tablets, effervescent tablets, sublingual tablets, mini tablets, etc.

C2F capabilities support efficiency projects such as conversion from wet granulation to direct compression. The center works with active pharmaceutical ingredients (APIs) belonging to OEL I-III categories, and it also can operate model APIs used for speed & flexibility. To meet most formulations requirements, the center uses a broad portfolio of excipients (including 3rd party ones) comprising 14 different categories of excipients and 60 different grades,
containing all relevant fillers, binders, and disintegrants to optimise any formulation.

These state-of-the-art lab facilities, of nearly 1200 m2, are equipped with the latest technology, for example an instrumented tablet press, an automated capsule filling machine, a tablet coater, a blister packaging machine, stability chambers, and state-of-the-art analytical equipment.
C2F is based in the Genome Valley at Hyderabad, the largest pharma and life sciences hub in South East Asia, where many major Indian and global (bio) pharmaceutical companies are present, as well as worldwide renowned research institutions and best-in-class supporting specialized infrastructure. It is a privileged location, as this R&D cluster drives collaboration and innovation among some of the global keyplayers in the pharmaceutical industry.

Also, C2F customers have access to consulting and analytical services during all the lifecycle stages of a medicine or nutraceutical product, thanks to the comprehensive expertise of DFE Pharma. The center also provides Asia-dedicated, as well as worldwide, regulatory support in the registration and approval of new products, for example providing user-friendly documentation and interpretation of regulations.

For more information, visit https://dfepharma.com/our-innovation-and-solutions/c2f/

Author Bio

Anil kumar S Gandhi

Anil kumar S Gandhi has more than 20 years of experience in the space of novel excipient development, application studies, and formulation development of Novel Drug Delivery Systems (NDDS) and generic formulations, and he has 35 granted patents and more than 70 patent applications to his credit. He has held different leadership roles in India and Taiwan at Rubicon Research Pvt. Ltd., Lotus Pharmaceutical Ltd., and Lyrus Life Sciences. Anil also served as Associate Professor at the Vivekanand Education Society's College of Pharmacy, India, and he holds a Master's degree in Pharmacy and a Ph.D. in Drug Delivery systems from the Institute Of Chemical Technology (Mumbai, India).

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