Verita Invests In GMP Compounding Pharmacy Facility In Sydney
Singapore, 7 December 2017 – Verita Healthcare Group (“Verita”) through its subsidiary Verita Innovate Pte Ltd has acquired a 19% of Acpharm Pty Ltd (with an option to acquire a further 32%) for the construction of a GMP Sterile/Non-Sterile Pharmaceutical facility in Sydney. The Non-Sterile facility commences production in October, 2017 with the Sterile facility expected to come online by Q2, 2018.
The facility has a foot print of approx. 700 m2. A 2-storey building, actual floor space is nearly double except for warehouse area.
It consists of one unit (Unit 3) of non-sterile clean room (50 m2) and warehouse and goods inwards/outwards and a second unit ( Unit 5) dedicated to QMS staff office (90 m2) and 4 individual sterile suites of approx. 80 m2 each suite.
Based on the size and excess capacity I believe this facility has the capacity to produce sales of $20 million per annum before any significant refurbishment or upgrade.
There are 5 clean suites. One non-sterile for creams and liquid production and 4 sterile suites with 3 different HVAC configurations for negative and positive air flow and a powder containment compounding area.
ACPharm’s main focus will be hospital supply in the boutique compounding area. With its pedigree in sterile pharmacy compounding to patients and doctor’s clinics the next obvious step was to enter into the fields of GMP compounding for supply to the Australian hospital system and Universities for clinical trials. ACPharm currently has an Annex 13 TGA Clinical trial licence for oral pastes and suspensions and is about to apply to expand our non-sterile license into solid dose form for clinical trials and small batch manufacture.
Our sterile facility will be focusing on large volume parenteral and small volume parenteral supply to hospital. Capabilities will include
Mono clonal antibodies
Total Parenteral nutrition
General small batch compounding preserved saline and specialized solutions
Veterinary Medicine for Equine, Camels, Companion Animals and wild species
Hormones, Anti Inflammatory steroids
Prefilled syringes for hospital pain management and eye disease and hospital ward use.
Clean Suite 1 – Is a positive pressure area which will be concentrating on Total Parenteral nutrition, nutritional products including veterinary as well as human, Monoclonal anti-bodies and other low hazard large volume injectable products in bags and small volume injectables in Vials.’
Clean Suite 2 – Is intended for syringe filling using nested vials and syringes.
Clean Suite 3- Will be another positive pressure areas with abilities similar to Clean Suite1. It will also act as a backup unit and excess capacity for the main operational suite.
Clean Suite 4 – Is a traditional pharmacy compounding suite. Designed for individual compounding of high hazard products from non-sterile starting materials and with powder containment area and a large scale CISA commercial autoclave for terminal sterilization processes.