Celadon Pharmaceuticals PLC Update on GMP Registration by MHRA (5392K)
December 22 2022 - 2:00AM
UK Regulatory
TIDMCEL
RNS Number : 5392K
Celadon Pharmaceuticals PLC
22 December 2022
Celadon Pharmaceuticals Plc
("Celadon" or the "Group")
Update on GMP Registration by MHRA
London, 22 December 2022 - Celadon Pharmaceuticals Plc (AIM:
CEL) , a UK-based pharmaceutical company focused on the research,
cultivation, manufacturing and sale of breakthrough cannabis-based
medicines, provides an update on the application for registration
of its West Midlands UK facility with the UK Medicines and
Healthcare products Regulatory Agency ("MHRA") for the Good
Manufacturing Practices ("GMP") manufacturing of its cannabis
Active Pharmaceutical Ingredient ("API").
Celadon has successfully made the necessary submissions to the
MHRA as part of its GMP registration, having received an MHRA
inspection of its facilities during Q4 2022. This is in line with
the timings provided in the Interim results announced on 29
September 2022.
Celadon can confirm that no critical issues were raised by the
MHRA during the inspection. As part of the audit, the Company also
sent samples of its API to an independent third party for
analytical testing. The Company is pleased to report that the
testing confirmed positive results across all batches, with
high-quality, consistent and pharmaceutical-grade API product.
Based on the above, Celadon remains confident that the Company
will obtain registration from the MHRA for the GMP manufacturing of
its cannabis API. The directors anticipate receiving this
registration during Q1 2023.
James Short, CEO of Celadon, commented:
"The Company is pleased to confirm that the inspection from the
MHRA and third-party testing of the batches of Celadon's cannabis
oil have now been completed in line with management expectations.
We remain confident that the Company will obtain registration from
the MHRA for the GMP manufacturing of its cannabis API during Q1
2023, following which we believe we will be one of a limited number
of GMP approved pharmaceutical cannabis facilities in the world.
This will be a significant milestone for the Company and will
unlock significant revenue opportunities."
Enquiries:
Celadon Pharmaceuticals Plc
James Short Via Powerscourt
Arthur Wakeley
Canaccord Genuity Limited (Nominated
Adviser and Broker)
Bobbie Hilliam / Andrew Potts / Patrick
Dolaghan +44 (0)20 7523 8000
Powerscourt Group
Sarah MacLeod / Nick Johnson / Sam Austrums
/
Ibrahim Khalil +44 (0)20 7250 1446
About Celadon Pharmaceuticals Plc
Celadon Pharmaceuticals Plc is a UK based pharmaceutical company
focused on the research, cultivation, manufacturing, and sale of
breakthrough cannabis-based medicines. Its primary focus is on
improving quality of life for chronic pain sufferers, as well as
exploring the potential of cannabis-based medicines for other
conditions such as autism. Its 100,000 sq. ft UK facility comprises
a laboratory designed to meet GMP standards, and capacity for a
large indoor hydroponic growing facility that has received a Home
Office Licence to legally grow high-THC medicinal cannabis for the
purpose of producing test batches of cannabis oil to support its
application to the MHRA. The Company's subsidiary, LVL, owns a MHRA
conditionally-approved cannabis trial using cannabis based
medicinal products to treat chronic pain in the UK. Celadon also
has a minority interest in early-stage biopharma Kingdom
Therapeutics which is developing a licenced cannabinoid medicine to
treat children with Autism Spectrum Disorder.
For further information please visit our website
www.celadonpharma.co.uk
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