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Indoco Remedies turns healthy on new initiatives

Jayanta Mallick

`The company is graduating from CRAMs to offering whole range of ANDAs'

Kolkata , Aug. 28

A section of the market players is attracted by new growth impetus for Indoco Remedies. The stock has gained over 30 per cent in the last one month.

According to analysts, Indoco partnering model for the regulated generics markets comprising milestone payments and profit sharing, filing of 7 ANDAs, beginning of exports to Germany, backward integration into active pharmaceutical ingredients (APIs) and gradual entry into high-margin non-regulated markets have marked implementation of a new initiative in the recent months.

"Indoco Remedies has set itself on a transition path and is graduating from CRAMs (contract research and manufacturing services) to offering whole range of ANDAs in the regulated markets like the UK and the US," according to Mr Rahul Sharma and Ms Rashmi Vora of Karvy Stock Broking. Exports, which constitute 16 per cent of the current revenues of Indoco, are expected to scale-up substantially going forward.

Indoco has already signed agreements with two generic companies in the US for the first seven ANDAs in the ophthalmic space. "Of the two, approval for one ANDA is expected this quarter. As preparatory work is over, the approval may kickstart a speedy commercialisation," Ms Aditi Kare, Director (business development), told Business Line over phone.

This would begin Indoco's contract research and manufacturing services to the biggest market.

The company has made modest beginning for contract manufacturing with a list of 18 branded generic products for a German company. Analysts expect this would pave way for more such arrangements with new European companies.

The acquisition of La NovaChem's API manufacturing facility last month with USFDA approvable standards, as a 100 per cent subsidiary of Indoco, is a strategic step towards bulk drugs and drugs intermediates. This has come close on the heels of operationlisation of a Rs-20 crore R&D Centre for APIs at Navi Mumbai.

After recent completion of the audit by the MHRA, UK for its Goa facility, Indoco will be able to conduct validation batches for clinical trials / BE studies for products to be registered in Europe. This will also give Indoco a right to supply the products for a period of five years from the date of commercial launch by its customers.

The approval for creams as well as capsules facility will enable Indoco to export two additional dosage forms to the UK. The approval has opened up the rest of Europe, Australia and the New Zealand as territories for export of formulations.

Plant inspection by the South African regulatory authority this quarter is expected to open up a new market in Africa for Indoco.

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