©2024 Pharmalicensing One, LLC 9/3/2024
Our client is EU-based R&D pharmaceutical company a MAH of Phloroglucinol ODT, offers licensing to global markets. The company follows superior business ethical standards all across its business process – from development to production.
Project highlights, below:
Ref.: Phloroglucinol ODT Licensing to EU, MENA and ex-USSR / May 2024
Phloroglucinol 80 mg ODT
Indicated in the treatment of pain caused by spasms (cramps) in the intestines, biliary tract, bladder and uterus as specified in the PIL
EU CTD
Reference product: SPASFON -SANOFI
Stability zone ii and iv
EU except GR, CY, RO, BL, IT
MENA
APAC
Former USSR
Licensing dossier + FDF supply
Licensee’s private label
An Asian vertically integrated EU GMP-certified factory produces both API and FDF
Safety profile (prescribes in pediatrics) vs. buscopan a major competitor
A free pricing drug with OTC status in a few EU markets incl. France with annual market worth 55 mln EUR +
Our Client is a Korean R&D and manufacture of a biomaterial for tissue restoraration using Polynucleotide (PN) which can be used in KOA and mesotherapy, looks for exclusive distributors in EU, and former USSR.
Project highlights, below:
Ref.: Portfolio of Knee Oeteoarthritis (KOA) and Mesotherapy for distribution in EU and ex-USSR / Apr 2024
High molecular DNA polymer with Viscoelasticity in prefilled syringes for KOA and Mesotherapy
Medical device Class III
CE mark and ISO
In-house manufacturing site in S.Korea
MA - the Distributor will run the MA procedure and medical device vigilance at own expense then
TM remains with a Korean MAH
Our Client is an EU-based R&D medical company has been developed a unique anti-inflammatory medical device for wound care – treatment of chronic inflammation and edema.
Project highlights, below:
Ref.: PEMF Technology Medical Device for Wound Care – Licensing to RoW ex-USSR / Aug 2024
A wearable patch that uses Pulsed Electro Magnetic Field (PEMF) technology to reduce exudate/edema/inflammation
It is medical device Class I
Exclusive distribution or licensing
The Licensee/Distributor will run registration in the Territory and be the MAH and will run the medical device vigilance then
Private label is possible
In-house manufacturing site in EU
Various clinical and case reports available
No patent
It is NOT a T.E.N.S.
It is NOT magnetotherapy since it works through a not continuous pulsed electromagnetic field
It is NOT sterile
Our client is an international pharmaceutical company with in-house R&D and manufacturing sites in EU and Asia, has been developed Ketorolac SL tabs with better and quicker absorption than IM or oral tablet for the short treatment of severe pain in adults.
Market Highlights and Competitors’ Landscape
The global Analgesics market is valued at $21.2 billion in 2020 is expected to reach $23.0 billion by the end of 2026 (CAGR 1.1%). Oral analgesics for acute pain include Paracetamol, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen. For moderate to severe pain tramadol, propoxyphene and codeine are widely used.
Project highlights, below:
Ref.: Ketorolac Sublingual (SL) tabs for licensing to the RoW and ex-USSR / Dec 2023
Ketorolac tromethamine
Dosage form - 10 mg sublingual tab
Zone II andIVb Stability data
eCTD dossier - ANVISA, Brazil format
Pack info - Amber colored PVC/PVDC Aluminum blister
In-licensing + supply FDF or blister
Licensee runs local BE studies and obtaining MA in the Trerritory
Licensee is a MAH with its private label in the Territory
In-house manufacturing site in Asia
EU-, EAEU-, WHO-,THA-, UAE MoH- SAHPRA-, Safety Korea-, Health Canada-ANVISA-GMP certified manufacturing site
SL formulation allows a rapid and direct absorption of the active ingredient bypassing hepatic first- pass metabolic processes seen with conventional oral route formulations.
Ketorolac is highly effective for prostaglandin-mediated pathologies causing pain and inflammation including trauma.
Ketorolac SL has been shown to be as effective as metamizole in the management of pain in short-stay surgeries.
Ketorolac SL is also as effective as piroxicam sublingual in the management of postoperative pain, trismus and swelling management in lower third molar removal.
Should you be interested in this opportunity, please send your request at
email or
WhatsApp.
Should you be interested in this opportunity, please send your request at
email or
WhatsApp.
Should you be interested in this opportunity, please send your request at
email or
WhatsApp.
Should you be interested in this opportunity, please send your request at
email or
WhatsApp.
Should you be interested in this opportunity, please send your request at
email or
WhatsApp.
Our client is a group of companies with pharmaceutical distribution, pharmacy chain, and a pharmaceutical factory assets. They look for in-licensing a vitamin D3 injectable.
Project highlights, below:
Ref.: VitD3 Injectables / Aug 2023
EAEU markets + opportunities to expand into other ex-USSR nations
Licensor's EU GMP certificate in possession
1. in-licensing agreement + FDF/in-bulk
2. supply technology transfer