HQ Team
February 9, 2023: Lupin Limited, an Indian maker of branded, generic formulations, biotechnology products, and active pharmaceutical ingredients, has got USFDA approval for its ANDA injection, glycopyrrolate.
According to a BSE filing, the product marks the first approval from the Mumbai-headquartered company’s facility in Nagpur in central India.
Glycopyrrolate injection is used before and during surgery to lessen mouth, throat, or stomach secretion, such as saliva and acid.
It is also used to prevent heart rhythm problems during anaesthesia, intubation or surgery.
Other applications include unwanted effects caused by certain medicines such as neostigmine and pyridostigmine.
Its side effects include hives, difficulty breathing, swelling of your face, lips, tongue, or throat, severe constipation, severe stomach pain, diarrhoea, painful or difficult urination, extreme drowsiness and shallow breathing.
Lupin’s Nagpur injectable facility is designed to the highest quality standards. It adheres to international regulations with advanced technology and equipment for consistently producing liquid, lyophilized vials, prefilled syringes, and cartridges.
“We are committed to building a strong injectable business as part of our growth strategy,” said Vinita Gupta, CEO of Lupin. “With the approval of our Nagpur facility, we can now fast-track our injectable portfolio rollout and build upon our R&D capabilities in complex products.
“The approval for Glycopyrrolate clears the path for more internally manufactured injectable products,” she said.
The injections’ annual sales are valued at $39 million. The company’s products are sold in more than 100 markets in the U.S., India, South Africa, Asia Pacific, Latin America, Europe, and the Middle East.
