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MCC-South Africa approval opens up key african markets for Amanta Biosciences

Jan 09, 2013 |

Ahmedabad, January, 2013: Amanta Biosciences, Indias leading manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) specialist, opens a new chapter in Africa with the award of the South African Medicines Control Council approval for six products manufactured at its Small Volume Parenterals (SVP) facility at Kheda. The South African market, at around USD 3.8 Billion (2011), is growing at 6% and is expected to reach $7 billion in 2018, with generics accounting for 60% of the volume.

The MCC approval will also enable Amanta Biosciences to achieve immediate access to key markets including Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Zambia, Malawi and Madagascar. MCC approval is expected to result in waiver of inspection by the authorities of these countries and an easier registration of certified products. For Amanta Biosciences, the approval carries the opportunity of accessing some of Africas most stable growth economies.

The Medicines Control Council is a statutory body that oversees the regulation of medicines in South Africa. Its main purpose is to ensure that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.

MCC-South Africas certification is also recognized by 43 participating authorities of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This may facilitate export by Amanta Biosciences of certified SVP to PIC/S participating authorities as well as non-PIC/S authorities who accept GMP certificates from PIC/S participating authorities.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP. (

Speaking on the MCC-South Africa approval, Mr Bhavesh Patel, MD, Amanta Biosciences, said: The MCC-South Africa approval for our Kheda facility will provide further impetus to our current expansion efforts in the African region and PIC/S countries. We would also augment our efforts by our own filing and licensing with new partners in SA. I see strong revenue potential in these under-served markets and we believe that we can make a quantum contribution to healthcare products in these countries.

Six products have obtained approvals from MCC-South Africa, including Sterile Water For Injections BP 5/10 ml; Ciprofloxacin Eye Drops 5/10 ml; Timolol 0.25% Eye Drops 5/10 ml; Timolol 0. 50% Eye Drops 5/10 ml; Lidocaine Injection BP 1% 5/10 ml and Lidocaine Injection BP 2% 5/10 ml.

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