Solara’s Visakhapatnam facility clears USFDA inspection with nil 483 inspectional observations

Solara Active Pharma Sciences announced on Monday that its Visakhapatnam facility has cleared the inspection carried out by the United States Food and Drug Administration (USFDA) with zero form 483 inspectional observations. The investigation at the facility was carried out from May 14 to May 17, 2024.

Following the announcement, shares of the company were trading over 1% higher. Solara’s facility in Visakhapatnam is a multipurpose active pharmaceutical ingredient (API) manufacturing unit. The facility is a green field project that is spread over 40 acres and has dedicated facilities to manufacture the Ibuprofen API. The facility also manufactures the key starting material for Ibuprofen and has achieved backward integration of its supply chain. Additionally, the facility has also begun validation of other APIs to register in various regulated markets worldwide.

Apart from the Visakhapatnam facility, the company also has a facility in Puducherry which manufactures the Ibuprofen drug substance.

Last month, the company had announced the sale of its wholly-owned subsidiary SeQuent Penems. Solara sold 100% of its shareholding in the company to Symbio Generics India for ₹12.5 crore.

During the third quarter of fiscal year 2024, Solara Active Pharma Sciences recorded a 38% year-on-year (YoY) decline in its revenue at ₹249.2 crore. The company reported an earnings before interest, tax, depreciation, and amortisation (EBITDA) loss of ₹161.6 crore in Q3FY24 as compared to an EBITDA of ₹51 crore for the corresponding period last year.

The firm stated that the third quarter was impacted by a fire at the company’s Puducherry facility and a temporary deferment of sales which led to the loss of revenue of ₹130 crore. The fire also resulted in lower margins and delayed shipments.

Shares of the company have risen by nearly 36% since the beginning of the year. The stock has gained over 37% in the last one year.