Formulation capabilities key to NPIL Pharma growth strategy

NPIL Pharma, part of India's fourth largest pharmaceutical company, is planning to invest in the region of US$50m over the next three years in its formulation services in the UK and India.

The programme includes a new sterile supplies pilot plant due on stream in Mumbai in the fourth quarter of 2007.

In the period 2004-06, the company invested a similar amount across its early phase (development) and late phase (manufacturing) formulation services, in the UK and India. Its formulations package now includes API pre-formulation services, formulation development for clinical trial manufacturing and scale-up to commercial manufacture in finished dosage forms - including injectables, solutions, capsules and tablets.

The focus on formulation services and final dosage forms follows capabilities added in last June's acquisition from Pfizer of the fully integrated API production and formulation facility at Morpeth, UK. As a result, NPIL Pharma now has an annualised aggregate drug formulation capacity of: 3 billion tablets; 500 million low RH (<8%) tablets; 270 million hard gelatine capsules; 180 million ophthalmic liquids (FFS Technology); 48 million glass vials and 30 million ampoules - supported by full packaging and supply chain capability.

The company will launch its fully integrated formulation capabilities to both existing and new small/virtual and large pharma customers in Europe and North America, via a series of roadshows scheduled to begin in the second quarter of this year.

'NPIL Pharma is uniquely positioned to offer integrated formulation services at all phases of drug development - from preclinical formulations to launch of commercial formulation - and with the additional assets and experience for global launch and commercial supply in final dosage form,' said Michael Fernandes, executive director responsible for NPIL Pharma's custom manufacturing business. 'This sets a new and highly competitive benchmark for what CMOs can deliver under the heading of integrated services.'

With annual custom manufacturing revenues of $250m - including approximately $100m. in formulation - NPIL Pharma is one of the world's top 10 pharma outsourcing companies. Leveraging its formulation strengths, by integrating capabilities in India, Europe and North America, is part of a strategy to elevate NPIL to a top three player.

'NPIL Pharma's integrated approach to drug development, with full partnership all the way from drug pre-formulation to launched product and lifecycle management is a highly distinctive offer to small/virtual and big pharma companies alike,' Fernandes claimed.

The company stresses the benefits of synergies between sites - recognising pre-formulation work at its Torcan early phase API facility in Canada and UK interaction between Morpeth and NPIL's early and late phase capabilities in Huddersfield. By 2010, NPIL Pharma aims to be the market leader in preformulation and formulation development to clinical manufacture of capsules, liquid-filled hard gelatine capsules, tablets, and in sterile aseptic solution and lyophilised injectables.