Globalpharma Receives South African Medicines Control Council Approval
This approval has confirmed Globalpharma's position as the first pharmaceutical manufacturing company in Dubai that adheres to international quality standards.
The approval will allow Globalpharma to market its penicillin products in South Africa as well as manufacture penicillin products for South African pharmaceutical companies in its premises in Dubai.
Globalpharma also plans to launch new products in South Africa in the coming year beginning with a range of Amoxicillin & Amoxicillin-Clavulanic acid combination under the brand names Glomox and Gloclav. Gloclav 375 mg and 625 mg tablets are currently pending registration in South Africa.
Glomox and Gloclav are antibiotics commonly used in different infective conditions like tonsillitis, otitis media (ear infections), sinusitis (sinus infections), bronchitis (respiratory infections) urinary tract infections and dental infection (after tooth extraction).
'The Medicines Control Council of South Africa is a health authority that follows very stringent standards of inspection and we, at Globalpharma, are thrilled to have received the 'Good Manufacturing Practice' (GMP) certification from it,' said Jamil Akhtar, General Manager, Globalpharma.
'The certification comes as an irrefutable piece of proof of the world-class quality standards we maintain and we believe that it is a big milestone in our journey towards other approvals from prominent international authorities such as the Medicines and Healthcare products Regulatory Agency, UK and the Food and Drug Administration (FDA), USA.'
The certification was based upon an inspection of Globalpharma's premises, personnel, manufacturing processes, quality assurance standards and controls systems, documentation and process validation systems, equipment and facilities qualification, instrument calibration and general maintenance of premises and equipment.
After due inspection the MCC committee, based on its observations of the Penicillin Manufacturing facilities at Global Pharma, resolved that it was 'satisfied that Global Pharma is in control to ensure that the medicines manufactured are in compliance with current Good Manufacturing Practices (cGMP's) and does recommend registration of medicines in respect of quality.'
'In line with its commitment to offer international quality pharmaceutical products to the Middle East as well as global markets, Globalpharma will look into entering other markets including the USA, UK and countries in the CIS region in the coming years. We are constantly striving to be a premier healthcare company that is people driven, ethical, socially conscious and committed to constantly delighting customers worldwide by delivering high quality medicines that improve the quality of human life,' Akhtar concluded.
Established in 1998, Globalpharma manufactures and markets its own pharmaceutical products including antibiotics, cardiovascular, anti-ulcerants, analgesic NSAIDs, food supplements, vitamins, anti-diabetics, respiratory products in more than 20 countries of GCC, Middle East, Africa and Far East, in addition to marketing in license products from some other multinational pharmaceutical companies.
SOURCE: Globalpharma