Services

Clinical Phase Formulations - Hormonal Formulations

Piramal Healthcare has been engaged in the manufacture and supply of hormonal formulation for over 40 years from our Morpeth site in UK.

The manufacturing operations are carried out in dedicated suites with once through air circulation. Personal protective equipment in the form of air hoods are utilised by operators wearing rubber overall suits which are rinsed by spray mist for personnel exiting the manufacturing suites. Cleaning validation systems are in place to minimise risk of products cross contamination

The site is equipped with both high shear granulation and fluid bed processor technology for the development and manufacture of solid hormonal formulation. The site has recently purchased Glatt bench top and Glatt mini equipment for development of hormonal tablets and Glatt GPCG 2.0 for scale up studies as well as small scale GMP batches ( upto 5 Kg) for product registration. An Aeromatic S4 processor (50–300 Kg) is used for commercial manufacture and a Killian T–200 machines are used for tablet compression

The site can manufacture hormonal formulation with a number of APIs and has been manufacturing a number of low dose oral contraceptives for over 40 years and has a capacity of approximately 1000 million tablets. Over 72 SKUs are currently supplied to 15 countries (including Japan). Ulmann blister packaging equipment capable of multi-phasic packaging and equipped with state of the art camera detection systems are primarily used for packaging. The site has ample space to add on packaging equipment for bottle packs, pouches etc required for different markets