PRESS RELEASE

Formulation Capabilities to leverage NPIL Pharma growth

Mumbai, 14 February 2007: NPIL Pharma has announced a new programme to leverage its global strengths in formulation services to further advance its position as a top tier player in custom development and manufacturing. The company is using InformexUSA to set out its integrated formulation development and manufacturing capabilities and to announce investment in new formulation facilities.

“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”, says 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”, notes Fernandes. 

Across its early phase (development) and late phase (manufacturing) formulation services, in the UK and India, NPIL has invested approximately US $50m. over the past three years - and plans a similar investment over 2007-09. The programme includes a new sterile supplies pilot plant due on stream in Mumbai in Q4 2007.

By integrating its capabilities and assets in India and Europe (UK), NPIL Pharma’s 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.

As part of India’s fourth largest pharmaceutical company, NPIL Pharma deploys a world class portfolio of formulations, dosage forms and matching R&D capability for the contract outsourcing market. 

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 annualized aggregate drug formulation capacity of: 3 billion tablets; 500 million low RH (<8%) tablets; 270 million hard gelatin capsules; 180 million opthalmic 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 Q2, 2007.

Distinctive combination:

With annual custom manufacturing revenues of US $250m. – including approximately US $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.

“It’s a distinctive combination of capabilities and experience along the total formulation and API value chain that creates the competitive edge”, notes Mike Fernandes. “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”.

Formulation facilities: 

NPIL Pharma combines pre-formulation, dosage formulation development and commercial scale formulation manufacturing across three sites – Mumbai and Pithampur in India and Morpeth, UK. Morpeth is FDA approved and Pithampur was recently inspected, with no 483s.

Morpeth has added a major suite of FDA-approved formulation assets to NPIL’s existing API development and manufacturing capabilities in Europe. It also significantly adds to NPIL’s Indian early/late phase formulation capabilities in Mumbai (R&D, development and sterile pilot plant) & Pithampur (solids pilot plant). (See: Notes for Editors)

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.

NPIL Pharma’s formulation development capabilities now span conventional and new dosage forms including tablets and capsules; sterile injectables; blow fill seal; lyophilized dosage forms; solid dosage forms under very low humidity; solutions; transdermals; sprays and foams.

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 asceptic solution and lyophilized injectables.

Latest in a series:

Development of an integrated formulations service is the latest in a series of investments/acquisitions to expand NPIL’s pharma custom services footprint, following acquisition of UK/Canada-based Avecia Pharmaceuticals in late 2005.

At CPhi 2006, NPIL Pharma announced the creation of a new business unit, NPIL Innovations – NPIL(i), to bring forward and apply new technologies for API process development and production. Dedicated to step changes that can accelerate commercial production efficiencies, NPIL(i) is working with both customers and the academic community. 

Its portfolio includes the new catalyst-based chiral racemisation technology SCRAM™, developed by NPIL Pharma (UK) to deliver process, cost and environmental benefits – and the technology focus also prominently includes biocatalysis, chemocatalysis and flow processing.

In the HPS niche, NPIL Pharma last Summer announced a US$500,000 upgrade investment at its High Potency APIs manufacturing facility in Grangemouth, Scotland.

Business units:

NPIL Pharma provides full lifecycle custom manufacturing and formulation services primarily through its early phase Pharma Development and Scale-up (PDS) and late phase Pharma Manufacturing Services (PMS) business units.

NPIL’s early phase API development capability is led by Torcan in Canada and supported by major facilities in both the UK (Huddersfield & Morpeth) and India. Late phase manufacturing is focused in Huddersfield, UK and Chennai and Hyderabad, India.

The PDS and PMS business units are complemented by niche capabilities in pharma. technologies – notably through NPIL (i) - and in High Potency Substance manufacturing, including cytotoxics and bioconjugates.

NPIL Pharma’s parent Nicholas Piramal India Ltd. is part of Piramal Enterprises Ltd. - one of India’s largest diversified business groups.

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Notes to editors: 

Formulation Facilities – India:

• The Mumbai R&D Centre houses a Preformulation team with capability for solubility, solution and solid state stability, early toxicity formulations, solubilization strategies, and full phyisco-chemical characterization. Early formulation capabilities offer fast turnarounds via efficient dosage form and analytical method development. 
  
  
• A state-of-the art sterile supplies pilot plant is being built in Mumbai for commissioning in Q4 2007. Clinical manufacturing of capsule and tablet dosage forms is focused at the Pithampur pilot plant. 

Formulation Facilities – UK:

• Facilities at Morpeth have capability for preformulation and early phase development formulation (small scale batches for pre-clinical and clinical studies); Phase III/commercial scale formulation manufacturing; tablet manufacturing and packaging and a containment suite for manufacture and packaging of hormonal/high potency tablet formulations.
  
  
• Production assets embrace large scale granulation, compression, encapsulation and coating capability – including press-coated, tablet-in-tablet capability and blister packaging lines with outputs ranging to 450 blisters/minute.
  
  
• Morpeth has a proven track record and capability to support multiple market launches and ongoing supply of packaged products, and is currently supplying over 300 finished dosage product forms to over 100 markets.

NPIL Pharma:

• NPIL Pharma has seven API and finished dosage production sites in India, including state-of-the-art R&D labs and kilo labs at Mumbai and Chennai; a GMP facility at Chennai and a commercial scale API plant at Hyderabad. The five production facilities in UK/Canada - Huddersfield, Grangemouth, Billingham, Morpeth and Aurora, Ontario (Torcan Chemical) - complement the Indian network, giving NPIL a vertically integrated global custom manufacturing footprint.
  
  
• NPIL Pharma employs over 2,000 people across its nine business locations. Parent business NPIL had financial 2006 sales of US $352m. NPIL is the flagship of Piramal Enterprises (PEL). Headquartered in Mumbai, PEL also has interests in retailing, textiles, auto-components and engineering.

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