Cipla Medpro Pharmaceuticals, South Africa

The Enaleni Pharmaceuticals manufacturing plant is in Durban, South Africa.

Enaleni Pharmaceuticals is now South Africa's sixth-largest pharma company.

Enaleni's new headquarters is in Cape Town, as of January 2008.

Enaleni also manufactures generics such as aspirin for other companies under contract.

Enaleni hopes to obtain part of the HIV drug contract for South Africa.

Cipla Medpro Pharmaceuticals is listed on the Johannesburg Securities Exchange and is one of South Africa’s top ten and fastest-growing pharmaceutical groups.

Formerly known as Enaleni Pharmaceuticals Ltd, the company is a leading supplier of chronic and generic medicine.

The Durban-based manufacturing facility, Cipla Medpro Manufacturing has recently undergone a R195m upgrade to international Pharmaceutical Inspection Co-operation Scheme (PIC/s) compliance, making it one of the first in South Africa to boast this accreditation.

The company acquired 100% of Cipla Medpro Products in 2005 for R1.2bn and is now integrating Cipla’s portfolio into its own operation. Cipla is supplying a great amount of Enaleni’s over-the-counter products to be repackaged in India through a 20-year supply contract.

Cipla Medpro reported that sales increased for the first two months of 2007 by 37.5%. The company now hopes to obtain a portion of the South African Government’s retroviral HIV treatment contract, worth $400m over a two-year period.

Refurbishment

In July 2007 new regulations came into force in South Africa from the Medicines Control Council (MCC). The MCC has been working to bring South African companies into compliance with international standards as required by the Pharmaceuticals Inspectorate Cooperation Scheme (PIC/S). The Cipla Medpro facility is the first PIC/S-compliant plant in the country.

The upgrade work was necessary because it was becoming difficult to ensure adherence to the MCC current Good Manufacturing Practice (cGMP) requirements in the old plant, due to ageing equipment.

Because of the enormity of the R125m (€12m) upgrade required for the Cipla Medpro plant, just south of Durban in KwaZulu-Natal, it was closed for several months from June 2007 to allow the first phase of the upgrade/expansion to be carried out more quickly.

The plant was able to reopen in September 2007 and obtained its manufacturing license from the MCC, despite phase two work still going on.

Cipla Medpro has worked closely with consultants CTC-Tech who are overseeing the upgrade work, and a number of other world-renowned experts in PIC/S compliance with regards to the new facility and expediting the upgrade.

The work to the 4,000m² plant includes:

• A new analytical laboratory
• New plant layout
• New primary processing equipment
• Individual air handling units in every room to control temperature, humidity and airflow
• New processes and equipment for tableting, liquids, effervescents and creams
• An overall four-fold increase in production capacity

Products

In addition to the company’s own portfolio of brands, which includes Bioharmony, Muscle Science (both divested), FirstPharm Pharmaceutical’s Hercules and Caivil, Cipla Medpro also manufactures on behalf of other companies such as Reckitt Benckiser (Dettol and Disprin), Pharma Dynamics and Merck Generics.