Freyr, a leading global Regulatory solutions and services provider, announced the successful submission of NCE-1 (ANDA) to the USFDA on behalf of Crystal Pharmaceutical (Suzhou) Co., Ltd, a technology-driven pharmaceutical company in China focusing on development of first-to-file (FTF) ANDA with polymorph and formulation barriers. Working closely with Crystal Pharmaceutical, Freyr made the submission within tight timelines aligning with client’ business requirements.
For such an NCE-1 (ANDA) project, pharmaceutical companies across the globe competed for the 180 days marketing exclusivity for their generic version of the product used for the treatment of chronic heart failure. To secure this goal, the NCE-1 (ANDA) has to be filed to the USFDA on time, in addition to passing bioequivalent test to reference listed product.
Freyr, with a clear-cut perspective on the exclusivity, took over the challenge and went for comprehensive gap analysis, meticulous dossier compilation, review, and publishing of 35,000 pages of the NCE-1 (ANDA). By proactive planning and collaboration with our client, Freyr ensured timely and successful submission with RTR-free. Five different in-house Regulatory teams of Freyr worked together for this submission.
“As a global Regulatory services provider, aligning to clients’ unique requirements is our top priority. And this critical yet successful NCE-1 (ANDA) submission is just another testimony for it,” said Suren Dheenadayalan, CEO, Freyr. “Though the project was demanding timely allocation of resources for meticulous review, and timely publishing and submission, we as a team feel accomplished in winning the clients’ confidence not only in successful submission of NCE-1 (ANDA), but by making it with no RTRs. Having this opportunity boosts our confidence and elevates our industry leader position to a newer height,” added Suren.
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small Size Global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.
Headquartered in New Jersey, USA, Freyr has regional offices across UK, Germany, UAE, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Austria, Sri Lanka and has Global Delivery Center in Hyderabad, India.
Crystal Pharmaceutical (Suzhou) Co., Ltd is a technology-driven pharmaceutical company in China focusing on development of first-to-file (FTF) ANDA with polymorph and formulation barriers. It collaborates with API manufacturers and generic companies to launch generic drugs as early as possible.
Headquartered in Suzhou, Crystal and its parent companies have three other sites located in Beijing-China, New Jersey-USA and Toronto-Canada.