Indian contractor Terrene Pharma has filed a DMF for hard gelatin capsules with the US FDA, signalling its intention to expand in the world’s most lucrative drug market.
Company vice president Bhavin Patel told Outsourcing-Pharma that having entered the expanding pharmaceutical sector in the Middle East and North Africa “we are now actively looking to develop the US market.”
He explained that: “The [DMF] declaration is a must before a potential client can use our capsules to formulate and sell their products in the US” adding that it is “formal recognition that our process of manufacturing capsules meets stringent regulatory standards.”
Patel predicted that: “This will open the doors to quality conscious formulation companies across the globe that are looking to add reliable vendors who can add real value to the top and the bottom line.”
The move fits with comments Terrene made at the inauguration of its Vadodara gelatin capsule manufacturing facility last year , which it said had been designed to comply with US and European regulatory requirements.
Closer to home Terrene recently received good manufacturing practice (GMP) certification from the Gujarat State government for the facility which, Patel added, is part of a wider quality focus.
“Terrene Pharma prides itself on its quality of product and we intend to strengthen our commitment to quality by seeking certification from various regulatory authorities.”
He added that: “We are already in the process of certifying our manufacturing plant as per WHO GMP and filing our EU DMF.”
And, beyond national and international regulatory filings and submissions, the contract manufacturing organisation (CMO) also wants to ramp up its output on the factory floor.
According to Patel the firm has “established the blue print to triple our production capacities for which are looking to raise capital via private equity.”