Alkem Laboratories Ltd announced in a BSE filing Monday it had obtained an Establishment Inspection Report for its manufacturing plant at Mandva, Gujarat, from the U.S. Food and Drug Administration (USFDA).
"The officials stated there are 'no pending observations on the plant', and the decision given was that the plant has been approved," a company official told International Business Times, India.
The plant manufactures active pharmaceutical ingredients (APIs) and was inspected by the USFDA in September 2015.
The facility at Mandva would be Alkem Laboratories' sixth plant to receive USFDA approval. The company's other plants approved by the USFDA include the formulation manufacturing facilities at Daman, Baddi in Himachal Pradesh, and St Louis, Missouri, in the U.S., and API manufacturing facilities at Ankleshwar in Gujarat and California in the U.S.
"This development reaffirms the company's focus towards the U.S. as its key market and further boosts Alkem's ability to enhance its product offering for this market," said Prabhat Aggarwal, CEO of Alkem Laboratories Ltd, in a statement.
Alkem Laboratories was the fifth largest pharmaceutical company in India by domestic sales in FY15. The Mumbai-based developer, manufacturer and seller of pharmaceutical and neutraceutical products, has 16 manufacturing facilities — 14 in India and two in the U.S.
The stocks of Alkem Laboratories Ltd closed at Rs 1,341 Tuesday at the BSE, up Rs 27.75 or 2.11 percent, after it announced the approval of its Gujarat plant.
