Gels, Creams, Lotions, and Ointments: Key Benefits and Differences
Semi-solid dosage forms are a class of pharmaceutical formulations that exist in a state between solid and liquid, exhibiting characteristics of both. These dosage forms are widely used in various applications, particularly in topical and transdermal drug delivery. Semi-solid dosage forms, such as gels, creams, lotions and ointments, are topical formulations designed for application to […]
505(b)(1) vs 505(b)(2): Understanding the Key Differences in FDA Drug Approval Processes
The 505(b)(1) pathway is typically used for new drugs with active ingredients that the FDA has not previously approved. This pathway requires a full New Drug Application (NDA) supported by detailed safety and efficacy data from extensive preclinical and clinical trials conducted by or on behalf of the applicant. In contrast, the 505(b)(2) pathway allows […]
Tablet Defects and How to Overcome Them in Manufacturing
Oral solid dose formulations, like tablets and capsules, are the most popular dosage forms for pharmaceutical drugs in the US due to their high medication compliance amongst patients and low manufacturing cost. A bottle of tablets for a monthly prescription can sometimes be manufactured for as low as five dollars, a cost virtually impossible to […]
Understanding Bioequivalence in Generic Drug Approval
Well over 80% of medicine prescribed in the US by volume are generics. Generic substitution saves the US healthcare sector billions of dollars and makes many medicines affordable to patients. Per the US FDA, even drugs that contain the same active ingredients at the same strength utilizing the same route of administration are not considered […]
Integrating cGMP in Clinical Manufacturing
Quality and safety are of utmost importance, among other critical factors, when developing a new drug. But clinical and analytical departments sometimes struggle to decide at which phase cGMP should be incorporated. What is cGMP? The acronym cGMP stands for Current Good Manufacturing Practices. These are regulations that are enforced by the FDA to ensure […]
Essential ANDA Checklist: Key Steps to Streamline Your Filing Process
Abbreviated New Drug Applications (ANDAs) are submitted to the FDA to seek approval for marketing generic drugs to the US market. As listed by the current FDA GDUFA requirements, sponsors must pay $252,453 to the FDA just to file an ANDA. This filing cost is set to increase to $321,920 in 2025. If the FDA […]
Vici Health Sciences Expands Staff and Footprint in Maryland to Meet Growing Customer Demands
Elkridge, Maryland–(Newsfile Corp. – October 8, 2024) Vici Health Sciences, a leading provider of pharmaceutical formulation, analytical, and regulatory services, is pleased to announce a significant expansion of its staff and physical footprint in Maryland. The expansion is in response to increasing demand for the company’s comprehensive pharmaceutical development services, enabling Vici Health Sciences to […]
Clinical Manufacturing Explained: How CDMOs Support the Development of FDA-Approved Trial Materials
The development of clinical trial material (CTM) is a critical phase in the pharmaceutical industry, especially in preparation for human clinical trials. Whether it’s an active pharmaceutical ingredient (API), placebo, or comparator drug, these materials must meet stringent FDA requirements to ensure patient safety and trial efficacy. Contract Development and Manufacturing Organizations (CDMOs) are key […]
NDA vs. ANDA: A Comprehensive Guide to Key Differences, Processes, and Regulatory Requirements
A New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA) are the two main pathways for getting drugs approved in the United States. For pharmaceutical companies, grasping the difference between NDA and ANDA is crucial for making smart product decisions. NDAs are intended for new drugs and require detailed clinical data to prove […]
Stability Chambers: Testing Methods, Essential Equipment, and Applications
Stability chambers are a must-have in pharmaceutical research and development. These chambers simulate precise environmental conditions to test the stability of drugs and other products in different settings. Here’s a closer look at the various testing methods used, the essential equipment involved, and how these chambers help maintain product quality and consistency in the pharmaceutical […]