Quality Control
Reaction Capabilities
Infrastructure
Quality Assurance

  NPIL's Global Manufacturing Plant

Based near Hyderabad, NPIL's APIs and Intermediates plant is one of the very few in India with very comprehensive international protocols and certifications. This gives a definite edge to NPIL's export strategy as the outsourcing partner of choice for pharmacos worldwide.

The plant is one of the very few USFDA plants in India. The plant is unique in that it has USFDA approval for the entire facility and not merely a product line, without and deficiency or non-conformity i.e. without any 483s. It is also accredited and approved by MCA of UK, TGA of Australia and the European and Canadian Drug Authorities. The plant also has ISO 9001 accreditation.

NPIL can now take advantage of the opportunities that will emerge in the bulk actives and intermediates market for outsourcing of both on patent and off patent drugs in the regulated markets of Europe, US and Japan. Capabilities will be critical in this business - manufacturing, process development (integrating with R&D), IPR protection, BD and supply chain management.

Significantly, NPIL is also well placed to offer manufacturing services across the entire life cycle of a product. Our capabilities today include not just lower cost dosage manufacturing, but the ability to manage costs through process innovation and the skills to aid in formulations R&D development and new dug delivery systems. We will also create further market opportunity by partnering with companies across the entire product life cycle, including the development stage. The company's capabilities enable it manufacture and partner at each stage of the life cycle. Our FDA approved manufacturing plant is best-in-class and is capable of all types of reactions.

The manufacturing facility with a pharma area conforming to Class 100000 comprises two dedicated facilities and one multipurpose plant.

At one of the largest single location AP/intermediate facilities in India, NPIL can offer research capabilities and manufactures bulk actives and drug intermediates in a completely environmental friendly ISO 14000 certified environment.

There are two dedicated manufacturing blocks and one multi purpose plant with a capacity of 165 reactors and a production capacity of 460 kilo litres. It has 38 centrifuges and 28 dryers.

The company manufactures Dilitiazem, Ketaconazole, Verapamil hydrochloride, Gabapentin, Benzethonium Chloride, Pentoxifylline, Itraconazole and Oxymetazoline hydrochloride. In addition, it manufactures intermediates for Dilitiazem hydrochloride, D(+) acid, Cis(+) hydroxylactum, Ketaconazole, Cis (+) bromobenzoate, Cis Tosylate, Cis mesylate, venlafaxine HCl, Flucanazole, Rosiglitazone, Cetrizine hydrocholride, Valdecoxib, Zaleplon and Leflunomide.

A 2000 square feet R&D facility enables the company to process and develop new APIs and intermediates while also supporting its existing products by developing efficient processes.

 

 

Google
Search WWW Search www.nicholaspiramal.com

Copyright© 2003 Nicholas Piramal India Limited