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- Opiate supplier Palla Pharma (PAL) has received the last approvals required to begin selling its Co-Codamol tablet and caplet products
- The company recently received MHRA approval to change the manufacturing site of those products to its production facility in Norway
- Today, Palla received the previously delayed MHRA approval of the updated Patient Information Leaflets and product packaging
- With all necessary approvals now finally granted, the company expects the first sale of its Co-Codamol products imminently
- Palla Pharma is up 28.57 per cent and trading at 72 cents per share
Opiate supplier Palla Pharma (PAL) has received the last approvals required to begin selling its Co-Codamol tablet and caplet products.
In early November 2020, the company received the green light to begin manufacturing its Codeine Phosphate and Paracetamol products. The approved Co-Codamol products consist of a 30-milligram Codeine Phosphate/500-milligram Paracetamol tablet and caplet combination.
With this achieved, the company applied to add its production facility in Kragerø, Norway as an approved manufacturer of Co-Codamol, under its own Marketing Authorisation. Towards the end of the year, the U.K. pharmaceutical industry regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), accepted the company’s application.
Earlier this month, the MHRA granted the application, and also approved updated text on the Patient Information Leaflets which accompany the products. However, formal approval of the Marketing Authorisation holder and site of manufacture name change variations to the leaflets were not granted at the time.
This delayed Palla’s timeline for producing, packaging, and selling its tablet and caplet products.
Today, Palla received the previously delayed MHRA approval of the updated Patient Information Leaflets and product packaging. With all necessary approvals now granted, the company expects the first sale of its Co-Codamol products imminently.
Palla has already produced initial batches of inventory in bulk tableted form, which are now on hand for immediate sale. These sales will begin shortly after the company completes packaging its pain relief products.
Palla has already identified several potential purchasers of its Co-Codamol products, with a further pipeline of possible customer interest established in preparation for the products entering the market.
Palla Pharma is up 28.57 per cent, trading at 72 cents per share at 2:19 pm AEDT.
