Mumbai: Orchid Chemicals & Pharmaceuticals Ltd, a Chennai-based pharmaceutical company, today announced that its facilities for active pharmaceutical ingredients (API) and formulations in Chennai have been approved by the Therapeutic Goods Administration, Australia (TGA).
A release from the company said an assessment team from the TGA had visited the facilities of Orchid located at Alathur (near Chennai) early this year and the formal approval certifying the facilities has been received. The TGA is part of the Australian Department of Health and Ageing.
This approval enables the marketing of Orchid's range of cephalosporin bulk drugs (sterile and non-sterile) and non-cephalosporin formulations in the markets of Australia and New Zealand.
Orchid has been increasing its focus on penetrating the high-growth regulated markets and this development will add further thrust to this initiative. This approval also signifies the quality compliant systems and processes that Orchid has put into place.
"This is one more milestone in our overall regulatory roadmap. This approval will enable our entry into the developed markets of Australia and New Zealand. We expect good revenues from our focus on the regulated markets during this fiscal," says Orchid managing director K Raghavendra Rao.
Orchid is a leading pharmaceutical company involved in the manufacture of cephalosporin and non-cephalosporin bulk actives, formulations and nutraceuticals. With exports spanning more than 75 countries, Orchid is the largest manufacturer-exporter of cephalosporin bulk actives in India and is ranked amongst the top five cephalosporin producers in the world.
Orchid's world-class manufacturing facilities for bulk actives, including the latest United States Food and Drug Administration (FDA) compliant facilities, are located in Alathur, a little away from Chennai, and in Aurangabad, 400 kms from Mumbai. Orchid also has dedicated manufacturing facilities for nutraceutical bulk active ingredients and formulations in Alathur.
Orchid's research and development facility located at Sholinganallur in Chennai is considered among the most advanced and state-of-the-art centre for applied research and analytical development. It also houses the new drug discovery infrastructure and a world-class pre-clinical toxicology and pharmacology centre, just commissioned. Orchid has also a modern, owned corporate headquarters (Orchid Towers) in Chennai that was inaugurated recently.
Orchid's flagship product Cephalexin was recently approved by the USFDA. Orchid has also been awarded certificates of suitability (CoS) from the European Directorate for the Quality of Medicines (EDQM) for three of its products. Orchid is one of the few pharmaceutical companies of its size and scale to have received the ISO 9001:2000 and ISO 14001 certifications for its world-class quality and environmental management systems, respectively.