In the dynamic world of pharmaceutical manufacturing and approval, understanding and navigating regulatory pathways is crucial. Two key elements in this domain are the European Pharmacopoeia  and Certificate of Suitability  (CEP) and the Active Substance Master File (ASMF). This

What is USP  There are many standards in the medical field, and these standards are crucial in controlling the quality of care. For instance, certification, licensing, and accreditation programs are frequently used by health care organizations to control the

For professionals in the pharmaceutical industry, comprehending the intricacies of the U.S. Food and Drug Administration (FDA) inspection process is crucial. These inspections are integral to ensuring that pharmaceutical products are manufactured in compliance with the highest standards of

In the pharmaceutical industry, maintaining market exclusivity is crucial for companies looking to maximize the return on their investments in drug development. This article delves into the concept of evergreening, a strategy used by pharmaceutical companies to extend the

The upcoming decade is poised to be a period of significant transformation in the pharmaceutical industry, marked by the expiration of patents for several high-value drugs. This shift presents both challenges and opportunities for pharma companies. In this article,

The pharmaceutical sector plays a crucial role in providing effective, safe, and affordable medications to the public. A significant part of this involves the introduction of generic drugs through the Abbreviated New Drug Application (ANDA) process. This explainer will

The facility tour is a critical component of the FDA inspection process. It allows inspectors to directly observe operations, evaluate the condition of the facility, and assess compliance with regulatory standards. This part of the inspection is designed to

First Mover Advantage refers to the competitive edge a company gains by being the first to enter a new market or segment. In the context of pharmaceutical generics, it pertains to being the first to market a generic version

The U.S. Food and Drug Administration’s (FDA) recent approval for Florida to import prescription drugs from Canada marks a significant development in the U.S. prescription drug market. This decision could pave the way for substantial cost savings for Florida,