Alembic Pharma's Panelav unit may get minor USFDA observations

Panelav unit near Vadodara manufactures formulations and exports to the US and other regulated markets

Vadodara-based Alembic Pharmaceuticals, which has seen the share of exports in its turnover increase three-fold in the last five years, is likely to receive some minor observations (as a Form 483) from the US drug regulator for its Panelav facility. This facility makes formulations. US accounts for nearly 80-85 per cent of Alembic's international formulations business.

The US Food and Drug Administration (USFDA) had conducted an inspection of the plant last week, and senior officials of the company felt that the inspection was more or less good, and there would not be any major observations.

A senior official of the company confirmed that Alembic is likely to receive a Form 483 from the USFDA and there is unlikely to be any major observations. A Form 483 is issued to a company after an inspection is completed and investigators have observed any condition which (in their judgement) may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related acts.

The official claimed that Alembic is yet to receive any formal communication from the USFDA and as such expects the 483 not to impact business in the short or medium term. "It should not affect our product launches or our exports as such. We are waiting for the letter, and would respond with details of the corrective actions we plan to take at the earliest," he said.

Panelav makes formulations for the regulated markets and has a capacity to manufacture seven billion tablets and capsules per year. The formulations business accounts for nearly 86 per cent of its revenues. The share of international business is around 50 per cent in its turnover. Alembic's turnover in 2014-15 was Rs 2,056.12 crore, which grew to Rs 2,513.82 crore in the first nine months of this fiscal.

The company has till date made 75 drug filings in the US, of which 45 abbreviated new drug approvals (ANDAs) have received approvals or tentative approvals. Around 30 are under approval. The company expects to launch at least seven to ten products in the US every year from 2016 onwards.

It launched six drugs in the US so far this year. It includes the blockbuster anti-psychotic drug Aripiprazole (Abilify), apart from Celecoxib (Celebrex), Valsartan Amlodipine (Exforge), Aripiprazole ODT (Ablify Discmelt), Memantine and Hydrochloride Tab (Nameda ).

Alembic has invested close to Rs 200 crore to expand its facilities this fiscal, and plans to invest another Rs 350-400 crore over the next one and a half years. It has already commissioned its Sikkim plant this year, and is expanding the Panelav and Karkhadi plants near Vadodara, which also includes setting up of an injectables plant.