The Product Development Laboratory (PDL) submitted 12 products to Ministry of Health (MOH), UAE for approval during the year. These products spanned such varied therapeutic segments as antibiotics, anti-hypertensive, antiepileptic, antifungal, anti-platelet, anti-ulcer and antibacterial.

 

The Department lent its support for registering manufacturers’ site with MOH, UAE during the year. The registered site, located in Europe, is to be used for production of hospital use analgesic.

 

Support was given for conducting initial stability studies for API “Insulin” manufactured by Julphar. This is part of the company’s strategy to produce world class medicines at an affordable price. This assumes added significance in the light of Julphar’s ambitious growth plans, going forward.

 

 

The Department is actively involved in post-registration compliance of submitted products in Jordan, Egypt, KSA, Iraq, Ethiopia, Sudan, Nigeria, South Africa, Malaysia, Philippines etc.

 

The year saw the completion of the analytical research laboratory. Restructuring of micro lab complying with latest GXP and in line with international regulatory requirements is planned. The analytical research laboratory is fully equipped to comply with regulatory requirements. Three additional stability chambers have been added for expanding capability of carrying out stability studies for compliance with regulatory agencies. New auto dissolution apparatus and HPLC systems have been added to strengthen compliance and post-registration support.

 

The PDL’s role in developing a portfolio of new products to drive the company’s future growth can never be over-emphasized

 

Preparing for the Global Challenges

A number of strategic products are in the pipeline for submission to the MOH, UAE in 2012. These products are likely to be produced both under license as well as through in-house development. Among well-known generic brands addressing a number of therapeutic segments are fourth generation antibiotic – Cefexime, treatment for erectile dysfunction – Sildenafil Citrate, immunosuppressant – Tacrolimus, and new combined Penicillin-Tazobactam + Piperacillin, to name a few.

 

Procurement and installation of state-of-the-art equipment for enhancing the technical capabilities of the formulation development of strategic generic products and analytical laboratory is likely to continue during the coming year. A number of equipment for laboratory-scale development are expected to be added to the Department’s impressive fixed assets.

 

The Department is also proposing to upgrade its laboratory with process development capability to meet the future challenges of scaling up of strategic products.