News

Perrigo to consolidate supply chain operations as part of downsizing

Perrigo, in an effort to hive off $175 million a year in costs, is laying off 6% of its workforce, among other steps.

UPDATED: Biogen's manufacturing feels the pain of its cost-cutting

Biogen has been adding significantly to its manufacturing network lately. Now, it has decided, it is time to subtract.

Feds get guilty pleas from suppliers in massive drug diversion operation

The FDA and the Department of Justice have taken down a couple more of the 33 players indicted in a massive drug diversion scam that undermined the U.S. pharma supply chain.

AstraZeneca opens plant in Russia

AstraZeneca has laid out a host of new manufacturing projects in recent months, including new biologics plants in Europe and the U.S. But while those projects are in the works, it has a new tablet plant in Russia that has just gone online.

FDA cites Cipla India plant after U.S. recall of asthma drug

In May, India's Cipla voluntarily pulled a lot of its levalbuterol from the U.S. market after the asthma inhalation drug failed a test for a degradant. Shortly after, FDA inspectors visited the plant in Indore where Cipla made the product and came away with issues tied to that recall.

FDA bans API plant of India's Megafine Pharma

The FDA last week added Megafine Pharma's plant in Lakhamapur, Maharashtra, in India to its import alert list, banning all of its drug products from entering the U.S.

Recipharm shelling out $105M for Indian sterile injectables CMO

Contract player Recipharm has been on a buying spree that now takes it into India to expand its reach in sterile injectables, one of the hot areas these days for both drugmakers and contractors.

TxCell, whose plant was closed for mold issues, intends to use CMOs exclusively

TxCell claimed it would have its manufacturing operations cleaned up and back online this year after French regulators shut it down for mold contamination. The French biotech now says it has changed its mind about that. It is pretty sure it will just turn over all manufacturing to contractors, which will mean canning the more than two dozen employees that work at its facility.

Hovione adding a formulation plant in Portugal

Portugal's Hovione is in expansion mode. After saying last month that it would add to its plant in New Jersey, the contract manufacturer now says it has acquired a formulation plant in Portugal.

Regeneron doubles down on plant project in Ireland

A couple of years ago, U.S.-based Regeneron said it would turn a former Dell computer plant in Ireland into its production operation outside of the U.S. But with the company booming, what started as a $300 million project needing 300 workers has morphed into a $650 million project that will require 500.

Myanmar offers incentives to lure its drug distributors into production

Myanmar has only a few companies making drugs for the country, leaving it to import more than 80% of its meds. Now the government is offering incentives to private distributors to coax them to move into production.

Medline recalls 500-mg acetaminophen labeled as 325 mg

Just months after a labeling issue led Reckitt Benckiser to recall 1.5 million bottles of cold meds with acetaminophen in them, Medline is having to do the same thing. In this case, bottles are marked with the wrong strength, which creates the danger that consumers could take too much acetaminophen and suffer liver damage.

Valeant's Bausch + Lomb plant getting $150M in investments, up to 200 jobs

Valeant Pharmaceuticals has been pumping out a lot of products at its Bausch + Lomb plant in South Carolina, reaching the 4 billion bottle mark this week. The company marked the occasion by announcing plans to invest in expansions that will add as many as 200 jobs over 5 years.

Chinese company intends to build plant to produce Ebola vax

A lot of companies, large and small, have jumped into a race to produce vaccines and treatments against the Ebola virus after an epidemic that began in 2014 killed 11,000 people in West Africa. Now a Chinese company says it will build a plant for production of a vaccine being tested by China's military.

GSK selling its drug distribution biz in Romania

GlaxoSmithKline, which has been chipping away at its supply chain in Romania with plans to close a plant there, will now unload its Romanian drug distribution business as well.

Ajinomoto Althea adding ADC, HPAPI manufacturing with new California plant

The Japanese conglomerate Ajinomoto gave its biologics manufacturing a shot in the arm several years ago when it bought San Diego-based CDMO Althea Technologies. Now it is building on that play with plans to add a facility capable of handling highly active materials such as antibody drug conjugates (ADCs).

Pests again figure into issues in FDA warning letter to Indian API maker

The FDA spanked an Indian API maker last month in a warning letter for having pigeons flying around its facility, as well as not adequately testing its products. Today yet another API maker got written up for pest problems. This time, in addition to birds in the facility, a lizard was seen crawling around in a storage warehouse. Oh, and there were also problems with testing drugs.

FDA issues Form 483 to compounder AmerisourceBergen is buying for $2.6B

The FDA issued a warning letter last year to PharMEDium Healthcare Holdings, the large compounding pharmacy operation that AmerisourceBergen said last week it would buy for $2.6 billion. But it turns out that FDA inspectors were back at the compounder's Cleveland center more recently and found that some problems with sanitation have yet to be resolved, while noting new issues.

CPhI report predicts growth in outsourcing for sterile injectables

In the latest installment of CPhI annual reports, Vivek Sharma, CEO of Piramal Pharma Solutions, predicts that there will be a 10% annual growth in the outsourcing of sterile injectables over the next 5 years and that U.S. producers will continue to be favored for that work, followed by CMOs in Western Europe.

Cipla's new U.S. plant received Form 483 just ahead of deal

Last month India's Cipla announced it had struck a $550 million deal to buy its first U.S. property, InvaGen Pharmaceuticals, getting a 350,000-square-foot manufacturing facility and portfolio of drugs. What it left out of the announcement is that its first U.S. manufacturing operation came with some FDA concerns. The facility received a Form 483 this spring for that plant, which the FDA did not post until two weeks after the deal was disclosed.