Resources

What is a CBE 30 Filing? What is a PAS? What’s the Difference Between ANDA and NDA?

What is a CBE 30 Filing? What is a PAS? What’s the Difference Between ANDA and NDA?

Although regulations often vary by region, regulators intend to protect public health. Regulatory authorities are expected to carry out their public health mandates by facilitating the timely introduction of new medicinal products to meet society’s requirements. At the same time, they are responsible for protecting the public from products of suspect quality, safety, and efficacy. As outlined...

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Bora Pharmaceuticals’ Bobby Sheng wins ‘CEO of the Year’ at CPhI Awards 2020

Bora Pharmaceuticals’ Bobby Sheng wins ‘CEO of the Year’ at CPhI Awards 2020

Bora Pharmaceuticals, a full-service contract development and manufacturing organisation (CDMO) which specialises in immediate and modified release tablets and capsules, along with serialised packaging, announced that its Chairman and CEO, Bobby Sheng, was unveiled as ‘CEO of the Year’ at the CPhI Pharma Awards 2020. The CEO of the Year award is granted to the C-suite executive who is able to...

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What Role Does QbD Play in Pharmaceutical Feasibility Studies?

What Role Does QbD Play in Pharmaceutical Feasibility Studies?

We are often asked, “Why do we need Pharmaceutical Feasibility Studies?”.  In the development of a new drug, it is important to note that a feasibility study is probably the single most important consideration. This is where, as your manufacturing partner, we begin to stress and optimize the formula, the process, the equipment train, and all the upfront variables that must be evaluated and...

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How a CDMO Can Increase The Competitiveness of Your Product

How a CDMO Can Increase The Competitiveness of Your Product

After 1990, the pharmaceutical industry shifted due to increased R&D spending, changes in the health insurance system, and the competition from new drugs and ones that were going generic. This shift drove increased complexity in supply chain operations. The demand for smaller production scale and shorter fulfillment times have been increasing. In some cases, this situation caused changes in...

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