Ipca rebuilds its US generics line from a 2017 FDA ban toward $200M (interview)

In an interview with ET, Ipca Laboratories managing director Ajit Kumar Jain said the Mumbai-based drug maker is gearing up for a strong return to the US generics business now that regulatory issues at its manufacturing plants are resolved. The US FDA had banned imports from Ipca's plants at Ratlam (Madhya Pradesh), Piparia (Silvassa) and SEZ Indore in June 2017, when the US business was generating $30–35 million a year; the ban cost the company years of US sales.

Two rebuilding blocks are in place. All of Ipca's plants have cleared US FDA inspection, and more than 40 products are filed in the US with most approvals now arriving. Ipca also acquired Unichem — paying around ₹1,600 crore including an open offer — for its manufacturing network, R&D and US distribution strength, even though Unichem had been making losses for years amid steep US price erosion and elevated raw-material prices.

Jain described a turnaround strategy for Unichem of reducing costs, unlocking operational efficiencies and scaling up the business. It has begun to show: Unichem reported a net profit of ₹22 crore for the first quarter of fiscal 2025, and its US business had revenue of around $120 million in FY24.

Ipca is now focusing on commercialising already-filed formulations and APIs, with 12–13 US launches planned over two years and 5–6 Unichem formulations in FY25, targeting consolidated US revenue of $200 million (₹1,675 crore) in the next 12–18 months. On a consolidated basis, Ipca increased revenue 23% year-on-year to ₹7,829.8 crore.

Unichem swung from years of losses to ₹22 crore Q1 FY25 net profit; Ipca targets $200M US revenue in 12–18 months (self-reported in the interview).

Keeping more than 40 US filings alive during the ban meant Ipca could re-enter with an approved product basket instead of starting the approval queue from scratch.

Buying Unichem added what the ban had destroyed fastest — a working US distribution and manufacturing platform — even though the target was loss-making.

Cost reduction and process efficiencies were the 'low-hanging fruit' that turned Unichem profitable before expansion spending begins.

Using Unichem's US strength to distribute Ipca's products lets the two merged portfolios reach the $200M target without building a sales arm from zero.

A regulatory shutdown is survivable if the product pipeline keeps moving: keep filings alive, buy a working distribution platform, and re-enter with scale instead of from zero.

The $200M target covers the 12–18 months after the August 2024 interview and is self-reported. Ipca's consolidated revenue rose 23% year-on-year to ₹7,829.8 crore in the period reported, and Unichem posted a ₹22 crore net profit in Q1 FY25.