Update on GMP Registration by MHRA

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 Arthur Wakeley	Via Powerscourt
Canaccord Genuity Limited (Nominated Adviser and Broker)
Bobbie Hilliam / Andrew Potts / Patrick Dolaghan	[phone]
Powerscourt Group
Sarah MacLeod / Nick Johnson / Sam Austrums / Ibrahim Khalil	[phone]

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

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 domain.

 

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