News

Australia's TGA issues updated guidelines on drug supply chain releases

SINGAPORE--Australia's Therapeutic Goods Administration (TGA) has updated guidance on the release of medicine products from the last manufacturer in the supply chain responsible for certifying the quality before the products are released onto the Australian market.

China grants GMP-approved facility for Tianyin Pharmaceutical

SINGAPORE--The Qionglai Tianyin Facility of Tianyin Pharmaceutical received its Good Manufacturing Practice certificate from the China Food and Drug Administration this week, notching up an important certificate to be able to sell at home and abroad.

Manufacturing key to getting more effective flu jabs to market faster

With the effectiveness of this year's influenza vaccines so low as to have made most of this year's vaccinations pointless, the industry is searching for avenues to abbreviate the 6-month development and manufacturing process to deal better with the kinds of virus mutations that came into play this year.

Belgian company investing in Indian API plant

Indian drugmaker Dr. Datsons Labs has told the Bombay Stock Exchange it expects a $17 million investment from a Belgium-based nutraceutical maker which wants access to one of its API facilities. According to VCCircle, the structure of the deal was not disclosed in the filing but Dr. Datsons said Eubage Laboratory intends to invest in its manufacturing operations and also outlicense 20 of its products to the Indian drugmaker.

FDA finds more counterfeit Cialis, warns consumers

Earlier this month the FDA stopped a shipment of what it believed to be Cialis manufactured in Australia that it said contained improper ingredients. Cialis maker Eli Lilly, however, said the product appeared to be counterfeit. It made no Cialis in Australia. Now the FDA is saying it has found Cialis fakes being shipped in the mail and is warning consumers to beware.

Gulf Pharmaceutical commits to sterile injectable plant in Ethiopia

When Gulf Pharmaceutical decided to invest about $10 million to build a pharma manufacturing plant in Ethiopia some years back, it seemed like a big risk, a company executive recently acknowledged. With a solid dose plant doing well, the United Arab Emirates-based company is ready to invest 5 times that in a sterile injectable drug manufacturing plant.

U.K. expands Wockhardt ban

In 2013, U.K. and European regulators banned most products from a Wockhardt plant in India that was found faking data, but the U.K. allowed it to continue shipping a few that were required for essential medicines. This week, the U.K. stiffened the action to include all active ingredients from Wockhardt's plant in Chikalthana, a facility the FDA has also banned from shipping to the U.S.

Biologics manufacturing helps Lonza to early turnaround

Growth in areas like antibody drug conjugates helped Lonza's Pharma & Biotech segment turn in more than 15% growth for the year and, in turn, helped the entire company realize one of its recovery goals a full year ahead of schedule, the Swiss company said Wednesday.

UPDATED: Actavis recalling 2,000 bottles generic seizure drug

Actavis has another drug recall to deal with, this one involving nearly 65,000 bottles of the generic version of the seizure drug Neurontin that it manufactures at a plant in India. The voluntary recall follows one in November of a drug that was key to its acquisition last year of Forest Pharmaceuticals.

FDA raises issues with another Apotex plant

An Apotex plant in Brantford, Ontario, was cited in a November inspection for equipment that was not properly cleaned and was found to be contaminated, according to a report in The Star. The plant was also cited for not having password-protected computers that could prevent employees from altering or deleting testing data.

India makes move to reduce reliance on Chinese APIs

Authorities in Himachal Pradesh have responded to calls to reduce restrictions on bulk drug manufacturers to help relieve India's reliance on Chinese APIs.

Novartis Puerto Rico cut in consumer JV with GSK

When Novartis announced plans to hand off its consumer health operations to a joint venture with GlaxoSmithKline, the companies said they figured they could save a boatload of money in "synergies." It looks like a small part of that will come from closing a Novartis plant in Puerto Rico that makes consumer and veterinary products, shedding 270 jobs in the process.

India's Piramal says it will snatch up university CDMO for its injectables skills

India's Piramal Enterprises said it was on the cusp of buying a CDMO founded at the University of Kentucky. That comes weeks after Japan's Fujifilm Diosynth Biotechnologies bought half of a vaccine manufacturing specialist from the Texas A&M University System.

Boehringer Ingelheim picks up contract work for Sanofi mAbs

At Sanofi, 72% of its drugs under development are biologics and half of those are monoclonal antibodies (mAbs). But instead of building a new plant right now, the French drugmaker will lean on Boehringer Ingelheim for additional mAb capacity.

Boehringer mulls sale of generic plant as stateside shakeup continues

Boehringer Ingelheim is considering severing more of its ties to drug production in Ohio. The latest asset to go up for sale is Roxane Labs, a Columbus, Ohio-based generics business that also produces some of Boehringer's patent-protected drugs.

New FDA quality office to grade manufacturing operations

The FDA has shared details of plans for its Office of Pharmaceutical Quality. Staffers plan to group drug production operations by category and release an average quality grade for each bucket, allowing manufacturers to see if they are outperforming their peers.

Piramal lines up $40M investment in equipment and technology

Piramal Pharma Solutions is lining up a $40 million investment to ensure its facilities have the equipment and technologies to keep clients and regulators happy.

FDA links saline supply chain mixup to patient death

The saline shortage may have claimed a life. The FDA reported that one person has died and many more have taken ill after receiving simulated intravenous products that are intended for training use only.

Indian state hires FDA's online education provider to train inspectors

The Indian state of Gujarat has hit upon a way to bring its inspectors up to international standards: Hire the company that provides online training to the FDA. Officials at the Gujarat Food and Drug Control Authority will have access to training services from UL EduNeering, the company that has helped the FDA develop its educational program since 1999.

Hospira to close Clayton, NC, production plant

Hospira is making cuts to its manufacturing network. The Lake Forest, IL-based drugmaker plans to close its facility in Clayton, NC, in June at a cost of up to 250 jobs and $15 million in severance payments and other employee-related costs.