Contract manufacturing facility updates
regarding updates to their facilities.
Following a $1.5m renovation, AAIPharma's sterile manufacturing plant in South Carolina, US, has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to produce aseptic and lyophilised products. The US Food and Drug Administration (FDA) has also previously approved the facility and the firm said the additional MHRA approval positions the plant to deliver aseptic contract manufacturing services to clients wishing to supply both commercial and clinical sterile drug products throughout the US and Europe. On the flipside, Glenmark Pharma has received good manufacturing practice (GMP) approval from the FDA for its semi-solid dosage manufacturing plant at in Himachal Pradesh, India. This plant has also received GMP approval from the UK's Modern Humanities Research Association (MHRA), as are its other formulation manufacturing facilities at Ankleshwar and Goa. The firm said that these regulatory approvals have opened "huge opportunities" and it also plans to launch additional products in the skin care segment. Likewise, biopharmaceutical contract manufacturer Angel Biotechnology has been awarded a manufacturer's and importers authorisation (MIA) by the MHRA. This license is a prerequisite for companies wishing to make biopharmaceuticals to sell in the UK. Chief operating officer Gordon Sherriff, said: "This fulfils Angel's strategy to provide its clients a complete service offering from preclinical development, through clinical trials, to commercial GMP manufacture of authorised products for sale". "We believe that this authorisation will strengthen our current client relationships and present many new business opportunities to Angel." In other news, Robinson Pharma has announced an upgrade to its soft gel inspection capability to a fully automated process using a Symetix optical inspection system. Traditional soft gel inspections involve humans visually inspecting trays containing thousands of soft gels a day, however, human error can creep in. According to Robinson, the new automated system digitally photographs each soft gel with up to four cameras and compares each the set of images to a reference standard image set of an accepted and approved dose, processing up to 1m doses per hour. In addition, the machine can check for irregularities in colour, size, shape, width, symmetry, and surface quality, as well as detect foreign objects or flaws such as twinning and rejects unacceptable individual doses with a jet of air as the product moves through the equipment, the firm said.
