Unichem Laboratories has announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Roha active pharmaceutical ingredients (API) facility.

The inspection, carried out between June 16 and June 20, 2025, was classified as Voluntary Action Initiated (VAI), reflecting the company’s adherence to regulatory requirements.

Unichem Laboratories develops and manufactures APIs and formulations, with a strong footprint across domestic and international markets. The company operates six formulations and Active APIs manufacturing facilities across India. Its formulation facilities are located in Goa; Baddi, Himachal Pradesh, and Ghaziabad, Uttar Pradesh. The company’s API facilities are based in Roha, Maharashtra; Pithampur, Madhya Pradesh; and Kolhapur, Maharashtra.

Set up in 1976, the Roha Plant was Unichem’s first API manufacturing facility, established for Metronidazole production. Over the past four decades, the plant has expanded to eight multipurpose production blocks. Spread across 48,885 sq. m., the unit is equipped to carry out a wide range of processes and operations, including ethoxylation, halogenation, hydrogenation, nitration, and sulphonation.

The company’s pharmaceutical bulk drug manufacturing plants are accredited by international regulatory authorities, including the US FDA, UK MHRA (earlier MCA), MCC (South Africa), WHO (Geneva), TGA (Australia), PMDA (Japan), KFDA (Korea), and ANVISA (Brazil).