La Chandra Pharmalab has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for its hormone Active Pharmaceutical Ingredient (API) manufacturing facility in Banaskantha, Gujarat, following a regulatory inspection conducted from April 20 to April 24.

The regulatory clearance makes the Banaskantha facility Gujarat's first dedicated hormone API manufacturing plant to receive USFDA approval, marking a significant milestone for the company and strengthening the state's position as a hub for advanced pharmaceutical manufacturing.

The facility is India's largest domestic producer of hormone APIs and manufactures key pharmaceutical ingredients, including progesterone, estradiol, norethisterone and other hormone APIs used in gynaecological and hormonal therapies.

In addition to the US FDA clearance, the facility holds several international quality certifications, including EU-GMP, WHO-GMP and Certificates of Suitability (CEP) for its hormone APIs. The company is India's only manufacturer with a CEP for progesterone and Asia's only manufacturer with a CEP for norethisterone, highlighting its expertise in the specialised hormone API segment.

The development also supports India's efforts to strengthen domestic pharmaceutical manufacturing under the Atmanirbhar Bharat initiative. According to the company, India previously relied heavily on imports for progesterone APIs, but domestic production has significantly increased over the past decade, reducing import dependence to below 30 percent, with La Chandra Pharmalab contributing to this transition.

The Banaskantha facility also houses the only Department of Scientific and Industrial Research (DSIR)-recognised research and development centre operated by a private enterprise in the district.

Commenting on the milestone, Priyvrat Gadhvi, Managing Director of La Chandra Pharmalab, said the US FDA Establishment Inspection Report validates the company's manufacturing systems and adherence to global quality standards. He noted that the approval is expected to strengthen the company's presence in regulated markets, particularly the United States, while supporting its international expansion strategy.

Gadhvi added that hormone API manufacturing is among the most technically demanding segments of the pharmaceutical industry. He said the company has established itself as India's leading hormone-focused API manufacturer by supplying major pharmaceutical companies, and that the US FDA clearance, alongside its growing footprint in Europe, marks the next phase of its global growth.

The company expects the USFDA clearance to boost exports to regulated markets while further enhancing India's reputation as a reliable supplier of high-quality pharmaceutical ingredients. The development also underscores Gujarat's growing importance in pharmaceutical manufacturing, research and exports.