News

Natco India plant gets Form 483 from FDA

Indian drug maker Natco has joined a long list of compatriots facing FDA concerns over manufacturing issues. According to The Financial Express, the company received an FDA Form 483 for a finished dosage plant in Telangana after an inspection in May.

Novartis says more cuts coming for New York Diovan plant

Novartis has notified the state of New York of its 83-employee layoff beginning Dec. 31 at its plant in Suffern, NY, a facility that will close in 2016, at which point essentially all traces of it will be eliminated.

Baxter issues recall, this time because antibacterial gets mixed in wrong carton

Baxter International is again recalling a sodium chloride product, but this time, instead of particulate contamination, it is because another product was mistakenly mixed in the shipment.

FDA procedural delay on Rytary gives Impax breathing room

The FDA has put off reconsideration of Impax Laboratories' Parkinson drug Rytary. The delay will give the California company some additional time to work on the latest in a series of FDA concerns over its manufacturing that have kept the drug sidelined.

More FDA issues arise for Hospira in India

About three months before Hospira closed on its acquisition of an API plant from India's Orchid Chemicals & Pharmaceuticals, FDA inspectors made a visit to the facility in Waluj. They had concerns with what they found.

Partner Sanofi wants to produce the insulin to be used in MannKind's Afrezza

MannKind signed a deal on July 31, 2014, to buy €120.1 million ($155.7 million) worth of recombinant human insulin from Amphastar France Pharmaceuticals to fill its inhalers.

India's top drugmakers forecast to invest $8B in production upgrades

India's 20 largest drug manufacturers are forecast to boost their plant investments by 40% by 2017-18, to more than Rs 50,000 crore ($8.3 billion), as they look to improve quality and chase new patent expirations.

Hikma opens oncology API plant in Jordan

Hikma has 27 manufacturing facilities in 11 countries. It recently bought a huge site in Bedford, OH, from Boehringer Ingelheim. But the company is not overlooking its home country of Jordan, where its new manufacturing plant got the royal treatment.

UPDATED: Merck KGaA negotiates huge production deal with Lupin

Merck is investing €80 million ($107.67 million) in a new plant in China to make treatments for diabetes and other conditions and to realize its aspirations there. But it appears it is looking to India as a way to cut production costs on some of its older products.

Gilead hands Sovaldi manufacturing tech to 7 generics makers

Gilead Sciences is presenting a huge gift to Mylan and half a dozen Indian generics makers. It is transferring the manufacturing technology for its biggest product and its blessing to go make cheap copies in 91 markets.

Hospira again reports a human hair discovered in a product

A loose hair has again tripped up Hospira, which is voluntarily recalling one lot of heparin as a result.

More counterfeits of Roche cancer drugs surface in Europe

Counterfeiters in Europe are displaying a fondness for mimicking high-priced Roche cancer drugs. For the second time in 5 months, authorities there have uncovered fakes, and the two cases appear not to be connected.

DOJ lawyer named director of FDA's Office of Compliance

The FDA has picked a successor to Howard Sklamberg to oversee the Office of Compliance (OC), Regulatory Focus reports.

Sources: FDA inspectors in Sun plant that has had recalls

Sun Pharmaceutical's U.S. subsidiary Caraco Pharmaceutical Laboratories has had a series of recalls this year of products that came out of a plant in Gujarat in India. Now the plant is being visited by FDA inspectors.

Apotex recalls Paxil tainted at GSK plant

Apotex, the Canadian generics maker that has had years of regulatory run-ins with the FDA, is recalling thousands of bottles of generic Paxil. This time regulators can't point fingers at Apotex. The drugs were manufactured by GlaxoSmithKline and are part of a larger recall for which the FDA spanked GSK.

Hospira will prep Indian workers at Vizag 'university'

When the sterile injectables plant Hospira is building in Vizag, India, opens, perhaps yet this year, the company expects the 1.1-million-square-foot manufacturing facility to add capacity at a lower operating cost. But a plant of that size requires a lot of workers, and so Hospira is also making plans to train the people it needs there.

FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them.

UPDATED: Merck again shipping BCG cancer treatment but Sanofi still is not

When a shortage of BCG vaccine used to treat tuberculosis and bladder cancer developed two years ago because of serious problems at a Sanofi Pasteur plant, the FDA asked Merck to pick up the slack. But Merck has had supply issues that interrupted production that it is only now resolving.

ProBioGen will double its Berlin staff to expand cell-based manufacturing

Contract manufacturer ProBioGen is joining a growing list of companies that are expanding their biologics manufacturing capabilities as more drugmakers need production expertise for cell-based drugs.

Germany's Aenova buys North Carolina packaging operation

Germany's Aenova has been in expansion mode. It pumped up production capacity with its acquisition last year of contract manufacturer Haupt Pharma and has now bought a U.S. company to help it boost its packaging capabilities.