Generics- Explore the Right Opportunities in the Right Market

 

Generics- Explore the Right Opportunities in the Right Market - Overview

The global Generics industry has come a long way from a nascent and niche market to a highly matured and developed market. The reason behind this is, firstly, the increasing cost pressures and demand for bringing affordable medicines to treat the patients. Secondly, the Regulatory support from major Health Authorities and governments in increasing the generic drug adoption, by incentivizing the generic drug manufacturing companies. Health regulators like the US FDA support manufacturers to gain approval in the US and other markets through international harmonization of technical and scientific standards for the development of generic drugs and provide manufacturers with an opportunity of 180-day exclusivity for generic drugs with Paragraph-4 certifications.

Another key development from Health Regulators in facilitating the generic is to promote the generic drug competition to branded drugs in the areas of complex generics/hybrid generics and to provide clear Regulatory guidelines and policies for delivering safe and high-quality generics.

With understandable Regulatory reforms and a large number of patent expiries between the years 2015-2020, there is a huge opportunity for generic manufacturers to produce low-cost alternatives for branded drugs. This means generic manufacturers must capture the market share as quickly as possible before competitors can develop a distinctive image in the market and build the maximum value for their generic drug product.

Freyr’s proven global Regulatory services assist generic pharmaceutical companies in evaluating the protection status of all branded molecules, their Regulatory procedures, and market dynamics across all the segments, to understand the generics opportunities and gaps in different regions around the world and optimize their service portfolio with an increased margin.

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​