News

Impax reports significant jump in revenues as it gets plant problems behind it

While remediation costs continued to drag on the financials for Impax Laboratories last year to the tune of nearly $24 million, the drugmaker still saw some improvements in its financials for 2014 and finally bagged approval of its treatment for Parkinson's disease early this year.

Bharat, Serum Institute ramp up production of their swine flu vaccines

Two Indian vaccinemakers are ramping up production of their swine flu vaccines, to replace stocks that were destroyed recently after they expired.

New Jersey compounder indicted over unsanitary manufacturing

The FDA has decided that not only were the operations of New Jersey-based Med Prep Consulting unsterile, they were illegal.

Wockhardt hit with new FDA concerns at banned plant

FDA inspectors returned to a Wockhardt plant in Waluj that it banned in 2013 and weren't impressed by what they found during the weeklong inspection. New concerns were raised.

Unused Forest Labs facility snapped up by Aprecia Pharmaceuticals

Pennsylvania-based Aprecia Pharmaceuticals this week announced its intention to purchase a never-used facility in Blue Ash, OH, built by Forest Laboratories in 2013.

Federal judge cuts off Maine's Internet drug supply chain

The ability of Maine consumers to get cheaper drugs from across the Canadian border has been on-again and off-again. Now it is off again.

Sun Pharma recalls epilepsy drug as dissolution woes continue

Another GMP issue has landed in Sun Pharma's inbox. The latest setback sees the Indian drugmaker forced to recall almost 3,300 bottles of its antiepileptic drug levetiracetam from the U.S. after the batches failed a 6-month dissolution test.

Mylan bags rights to distribute Gilead's Sovaldi in India

Gilead has named Mylan as the exclusive distributor of branded forms of its hepatitis C blockbusters Sovaldi and Harvoni in India.

Sagent brings production in-house after FDA finds fault with Indian CMO

Sagent Pharmaceuticals has transferred production of atracurium besylate injection to its own plant after the FDA spotted GMP problems at the CMO that was manufacturing the drug. The FDA observations relate to aseptic practices at Emcure Pharmaceuticals, an Indian manufacturer behind earlier recalls by Pfizer and Teva.

Lupin plant hit with Form 483 but continues to rack up approvals

The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has done little to slow the rate of approvals for the facility, which has racked up two site transfer nods and one ANDA go-ahead since receiving the Form 483.

McKesson outed as company behind 340,000-sq-ft distribution hub in Iowa

After almost a year of speculation and secretive negotiations, officials in Iowa have revealed that drug distribution giant McKesson is behind the 340,000-square-foot warehouse being built in the state. McKesson will use the site to distribute products across 7 states when it starts operating in May 2016.

India turns to small manufacturers for state-run generic supply biz

The Indian government has revealed details of its plan to establish itself as a supplier of low-cost, high-quality generic medicines. Instead of relying on the big beasts of Indian generics production, the government is to source its drugs from small and medium-sized players.

Protein Sciences cancels expansion plans after governor gets flu shot from foreign competitor

Connecticut-based flu vaccine maker Protein Sciences has cancelled its expansion plans after learning the governor got his flu shot from a foreign competitor. The Meriden, CT-based company nixed negotiations to buy two local properties after hearing of Gov. Dannel Malloy's faux pas.

InvaGen Pharma and AlphaMed Bottles building new plants on Long Island

Generics drugmaker InvaGen Pharmaceuticals and AlphaMed Bottles, both co-owned companies, said they will build two separate manufacturing facilities in Central Islip, located on Long Island, NY.

WuXi inks deal to borrow $165M to support manufacturing growth

WuXi PharmaTech, China's largest CRO with nearly $350 million in new manufacturing facilities, is borrowing $165 million to help finance the construction and expansion of its production capabilities.

Taro recalls nearly 37,000 bottles of children's allergy relief syrup

Taro Pharmaceuticals, a subsidiary of India drugmaker Sun Pharmaceuticals, issued a recall of nearly 37,000 bottles of grape-flavored loratadine syrup, an antihistamine used to treat allergy symptoms in children.

India mulling plans to build bulk drug manufacturing capacity

The Indian government is expected to announce new strategies to bolster its bulk drug manufacturing capacity as part of an effort to reduce the country's dependency on Chinese API imports.

Taro Pharma the one bright spot for Sun earnings

Sun Pharmaceutical subsidiary Taro Pharmaceuticals was the one bright spot in the Indian-based drugmaker's Q3 fiscal universe reported late last week.

Pharma polluter gets probation, not prison as feds sought

Federal authorities hoped to make an example of the owner of a small Connecticut pharma manufacturing operation that they said ignored warnings and had polluted waste water dumped into the sewers.

Samsung BioLogics to expand new Songdo plant

South Korea's Samsung BioLogics has pledged to be a big deal in biosimilars, but so far its biologics subsidiary has produced mostly operating losses for its parent. In anticipation of turning that around, the company will undertake a significant expansion of the biologics plant in Songdo, Incheon, that it opened in 2013.