The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.
The announcement will create the fifth largest generics drug maker, reports Reuters.
The drugmaker says the voluntary measure was out of an abundance of caution.
The FDA commissioner said the agency is doing its job, not picking a fight, when it inspects drug-making facilities, and that India must take an active role for a harmonious supply chain.
The FDA finds problems at another plant.
1,100 workers will lose their jobs at a plant with a history of around 40 recalls.
Akorn expands, buying Hi-Tech Pharmacal; nursing homes miss their goal to curb antipsychotic-drug use; Bayer cancer drug gets priority review; and Lonza lays off staff
FDA grants Teva three years exclusivity to sell Plan B OTC for all ages; FDA gives Humira a thumbs-down for spondyloarthritis; a UK vaccine committee rejects Novartis' meningitis B shot; and Wockhardt gets a warning letter from FDA for its manufacturing practices at an Indian plant.
The regulator says Merck needs to focus on lower doses of the drug.
Bayer's prostate cancer drug clears FDA three months early; a House committee is pressing the regulator for employment transparancy; and Ranbaxy takes a multi-million dollar hit over violations
Medical science liaisons will educate nuclear-medicine clinicians as part of the launch of a new Navidea diagnostic agent for use in breast and skin cancer.
Novartis is hyping its relaunch of Excedrin with a celebrity spokesperson, a migraine app and a survey of women migraine sufferers - along with print and out-of-home ads, radio promotions, direct mail and social media.
Eli Lilly to add manufacturing capacity in Indianapolis, Novartis invests more in Singapore
The deadly meningitis outbreak highlights the threat not only to public health, but also to the pharma industry, posed by the largely unregulated practice of pharmacy compounding.
UBM Medica adds a third iPad app, BMS expands in Puerto Rico.
GlaxoSmithKline is building its first new UK factory in almost 40 years, the firm said, spurring jobs while breaking new ground at some of its current locations.
Sanofi is girding itself for an ugly year, forecasting a 12%-15% drop in business earnings per share for 2012 as the company absorbs the loss of patent exclusivity on a stable of drugs that brought in more than €4 billion last year.
J&J is pushing back hard against a Wall Street Journal article suggesting that a pair of retirements and a promotion are part of a corporate shakeup of its recall-plagued McNeil Consumer Healthcare division.