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South Africa drug authority approves Amanta’s 6 products

Jan 05, 2013 |

AHMEDABAD: Ahmedabad-based Amanta Biosciences, a sterile parenteral maker company receives South African Medicines Control Council approval for six products manufactured at its Small Volume Parenterals BSE 3.26% (SVP) facility at Kheda, Gujarat.

According to company’s press statement, the South African market is estimated at around $3.8 billion and is growing at 6%. It is expected to reach $7 billion in 2018, with generics accounting for 60% of the volume. The company further says that this approval will also enable it to achieve immediate access to key markets including Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Zambia, Malawi and Madagascar, as South African Medicines Control Council (MCC) approval is expected to result in waiver of inspection by the authorities of these countries. The MCC is a statutory body that oversees the regulation of medicines in South Africa.

Bhavesh Patel, MD, Amanta Biosciences, said: “This approval 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.”

According to the company, 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.

Amanta Biosciences established in 1988 is engaged in manufacturing and marketing of sterile liquid parenterals using Aseptic Blow- Fill- Seal technology, for both large & small volume parenteral.

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