News
& Events
What´s new at Flavine? We´ll keep you updated on any development and news on this page. Feel free to share also our event informations!
New US DMF Filing – Ruxolitinib Phosphate
We are proud to announce the filing of a new US DMF (041214) for Ruxolitinib Phosphate, registered to Flavine. Validated commercial-scale API is now available for immediate use.
Beyond Ruxolitinib Phosphate, we are positioned to collaborate on alternative salt forms, polymorphic crystals, and novel dosage form development programs.
Flavine has partnered with a reputed CDMO to develop and manufacture Ruxolitinib Phosphate API. Flavine can support your filing strategy by utilizing our expertise of serving the generic industry for 50 years.
Ruxolitinib Phosphate is a potent and selective anticancer, inhibitor of Janus kinase‑1 and Janus kinase‑2. As a BCS Class I drug, it is a candidate for BCS bio-waiver in lieu of BE study.
Ruxolitinib Phosphate is indicated for these therapeutic treatments:
- Intermediate or high-risk myelofibrosis (MF)
- Resistant forms of polycythemia vera (PV)
- Acute and chronic graft-vs-host disease (GVHD)
- Topical treatment of atopic dermatitis
- Topical treatment of nonsegmental vitiligo
Contact Flavine for Ruxolitinib Phosphate samples and more information on other salts.
Disclaimer: All products which are covered under current patents are available only for use reasonably related to the development and submission of information to the related Health Authorities to the extent permitted under applicable laws regulating the manufacture, use and sales of Active Pharmaceutical Ingredients and/or their intermediates.
New Development — Ruxolitinib Phosphate API
Approved Ruxolitinib Phosphate finished dosage forms:
- JAKAFI® (oral tablets) by Incyte Corporation
- OPZELURA™ (topical cream) by Incyte Corporation
- JAKAVI® (oral tablets) licensed to Novartis
New Laboratory Facility
New EU Retest & Release Laboratory
In a world where the healthcare revolution is increasingly transforming our lives, Flavine is leading the expansion of sourcing activities for its customers. For more than 45 years, we are thriving to add value to the business of both suppliers and customers by locating and developing quality manufacturers and opening up new markets.
Flavine is excited to announce our new, state of the art, GMP-compliant laboratory facility that offers comprehensive analytical services, QC retest, and release testing of active pharmaceutical ingredients and finished dosage forms. Complementing our full-service QC testing, we also provide robust method development, validation, and transfer of pharmaceutical products and raw materials.
New GMP Sampling Installation:
- Changing room
- Sampling area with laminar air flow and HEPA filtration
- Suitable scales for various package shipment sizes
- Interlocking doors system
- Separate operations for the flow of material and personnel
- Routine environmental monitoring
- Control and monitoring of microbiological quality
- Airlocks and pass-throughs chamber
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