FDA approves generic Methergine tablets
Granules Pharmaceutical, the U.S. subsidiary of Granules india, has received Food and Drug Administration approval for its generic Methergine tablets (methylergonovine tablets). The drug is indicated to prevent and control postpartum hemorrhage.
The approval is Granules’ first, and the company said it also would be the first generic for the product, marketed by Lupin, on the market. Granules’ generic will be available 0.2-mg dosage strength.
"Granules Pharmaceuticals, our R&D and manufacturing subsidiary in Virginia was established with an objective to foray into the development and manufacture of products that are niche, on several levels,” said Granules India chairman and managing director Krishna Prasad Chigurupati. “Our first product approval from this site is a first generic to the market and is a testimony to our objectives and execution capabilities.”
The approval is Granules’ first, and the company said it also would be the first generic for the product, marketed by Lupin, on the market. Granules’ generic will be available 0.2-mg dosage strength.
"Granules Pharmaceuticals, our R&D and manufacturing subsidiary in Virginia was established with an objective to foray into the development and manufacture of products that are niche, on several levels,” said Granules India chairman and managing director Krishna Prasad Chigurupati. “Our first product approval from this site is a first generic to the market and is a testimony to our objectives and execution capabilities.”