FDA Issues Import Ban for Indian Drug Manufacturer

News
Article

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and ManagementPTSM: Pharmaceutical Technology Sourcing and Management-10-07-2015
Volume 11
Issue 10

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.

FDA has issued an import ban on Sept. 11, 2015 for products manufactured by Polydrug Laboratories at the company’s Ambernath Industrial Area manufacturing plant in Mumbai, India, due to problems with good manufacturing practices for human and animal drugs.

The company manufactures anti-hypertensive, anti-fungal, anti-microbial, and muscle relaxant drugs, and distributes products in Mexico, China, Korea, Russia,Taiwan, Singapore, and Ukraine, according to information posted on the Polydrug Laboratories website.

Reuters reports that Canada and Europe banned products from the same site earlier this year.

Source: FDA Import Alert

Recent Videos
Tore Bergsteiner from MAIN5 details his predictions for how the mega trends will shape the bio/pharma industry in 2025 and beyond.
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.