Inspection of manufacturing plant and approval of GMP by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), Peru

Inspection of manufacturing plant, approval of GMP and gaining of export approval from Ethiopian Food and Drug Administration (EFDA), Ethiopia

Export approval from National Drug Authority (NDA), Uganda

Acquiring of Export Approval from the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria.

Conduction of ISO (9001:2008) Surveillance Audit.

Pharma Technical (PT) Good Manufacturing Practice (GMP) Audit by Roche.

Recipient of ISO 9001:2008 Quality Standard certified by Orion Registrar Inc., USA.

Inspection of manufacturing plant by Medicines Control Authority of Zimbabwe

Approval of GMP Compliance, Pharmacy and Poisons Board, Kenya.

Conduction of ISO (9001:2008) Surveillance Audit.

Recipient of ISO (9001:2008) Certification.

Renewal of Biological & Non-biological product manufacturing license.

Compliance with cGMP according to the Compendium of guidelines and related materials.

Site transfer from Novartis (Bangladesh) Ltd. to Klarris Pharmaceuticals Ltd.

Pharma Technical (PT) Good Manufacturing Practice (GMP) Audit by Roche.

Formation of Klarris Pharmaceuticals Ltd.

Licensee agreement with F. Hoffmann-La Roche Limited, Switzerland.

Renewal of Biological & Non-biological product manufacturing license.