Nottingham, UK – Juniper Pharma Services, a subsidiary of Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) has been granted permission by the Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture and supply bulk unlicensed medicines.
This licence from the UK’s regulatory body allows the contract development and manufacturing organisation (CDMO) to produce tablets, capsules and other solid oral dosage forms intended for use as unlicensed medicinal products, more commonly known in the UK as “Specials”.
Specials are prescribed in the UK when a patient needs a very specific formulation of a drug that isn’t available as a standard licensed medicine. Under the licence, Juniper Pharma Services intends to manufacture and supply certain non-sterile medicines in bulk required by specials suppliers that can in-turn wholesale and retail such medicines to pharmacies.
Claire Madden-Smith, VP commercial services at Juniper Pharma Services said: “Many Specials producers and wholesalers in the UK do have in-house manufacturing capabilities but these are often restricted to producing one-off medicines for patients.
“As a result, these companies often require an outsourced manufacturing partner like Juniper Pharma Services to produce certain medicines in bulk supply on their behalf to help overcome capability restrictions, reduce unit costs and help maintain required stock levels.
“This Specials licence therefore allows the company to meet such market needs from our manufacturing facility, which is equipped to deal with such production requirements.”
Juniper Pharma Services is the new brand name for Molecular Profiles after the company unveiled its new brand identity earlier this week to coincide with its Boston-based parent company adopting as Juniper Pharmaceuticals, Inc. its new brand identity.
The company has well-established tableting and capsule filling capabilities and the company continues to experience increased demand for its topical and oral dosage form products, including the supply of potent compounds and controlled drugs.
The move into the Specials market by the science-led CDMO is a natural extension to the company’s clinical manufacturing capabilities, which is focused on delivering product supply for small scale early trials up to Phase III and beyond.
Since 1999, Juniper Pharma Services has built a strong reputation in advanced characterisation, IP consultancy and sophisticated analytical services. The company works with pharmaceutical companies across the world that are developing small molecule drug products.
The CDMO assists clients by giving them a solid understanding of their compounds in terms of stability, solubility and structure. This helps minimise risk of failure during clinical development while ensuring a robust and scalable process is in place.
In recent years, it has developed complementary collaborations with Onyx Scientific, XenoGesis and Xceleron, which broaden its expertise to give clients an end-to-end solution using a connected network of industry experts to give drug developers a clear pathway of how to take compounds from early stage work through to clinical trials.