Aurobindo Pharma Ltd's betalctum facility, has been endorsed by South Africa''s Medicines Control Council.
US FDA and Brazil''s ANVISA have also approved Aurobindo's betalctum facility, also called Unit XII, apart from approvals from other countries and the Indian ISO.
Medicines Control Council of South Africa, in its resolution following the facility inspection for quality, has conveyed that the facility is in compliance with current Good Manufacturing Facilities and recommends registration of the products manufactured there.
Unit XII is dedicated to manufacture the high-end betalactum range and the plant is capable of manufacturing injectables, powder for oral suspensions, tablets and capsules. The facility is spread over 15,228 sq. meters, with a built up area of 12,180 sq. meters.