The Hyderabad-based Glochem Industries Ltd, manufacturer of active pharmaceutical ingredients (APIs) and intermediates, is all set to enter the formulation segment by setting up a facility for the same at the Jadcherla special economic zone (SEZ). The move is with a view to enter contract manufacturing segment, it is learnt.
According to the company, the facility, which is coming up with an investment of Rs 20 to 25 crore, will be as per major regulatory compliances such as the cGMP, USFDA, UKMHRA, TGA and MCA. The new facility, land for the same has been already acquired, is expected to be operational in another 18 months. It will have the capacity to manufacture about 1 billion tablets and capsules per annum.
Speaking to Pharmabiz, Subbarao, managing director, Glochem Industries Ltd, said, "We are entering into the formulation segment and we have already acquired land for a formulation facility at the Jadcherla SEZ. It is mainly with a view to meet the outsourcing requirements of dosage forms by the company's customers for the APIs. Quite a few of the company's customers are currently getting their dosage forms manufactured by other contract manufacturers in India by using the APIs sourced from us. All of them can be potential customers for the formulation division".
The company is hoping to enter contract manufacturing agreements with several big companies in India as well as abroad for the regulated markets such as EU, US, Australia and South Africa. As per the company, it will also be able to files MAs and ANDAs for direct marketing of the dosage forms to other generic or marketing companies in the US and EU.
The company is planning to launch products such as Raloxifene HCI, Clopidogrel Bisulphate, Candesartan, Telmisartan and Eprosartan in the regulated markets with the expiry of their patents. It has already completed the development of these products and is in the process of completion of validation batches and preparation of DMFs. The company has already tied-up with quite a few generic companies in the Europe and US to launch its products in these markets. It is also entering into some contracts and arrangements for the development of EU dossier for some of its APIs.