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REG - Celadon Pharma. PLC - Update on GMP Registration by MHRA

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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 /             +44 (0)20 7250 1446

 Ibrahim Khalil

 

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
(http://www.celadonpharma.co.uk)

 

This announcement contains inside information for the purposes of article 7 of
the Market Abuse Regulation (EU) 596/2014 as amended by regulation 11 of the
Market Abuse (Amendment) (EU Exit) Regulations 2019/310. With the publication
of this announcement, this information is now considered to be in the public
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