Genco adds two scalable warehouses for healthcare manufacturers
PITTSBURGH — Genco, a FedEx company, introduced Tuesday its multi-tenant warehouse solution in the U.S. and Canada aimed at meeting healthcare manufacturers’s evolving needs. The multi-tenant solution allows multiple manufacturers to operate alongside one another in a single warehouse, using a designated space with a shared technology platform.
“Due to increasing margin pressures within the healthcare industry, manufacturers … are hyper-focused on streamlining their supply chain and enhancing overall efficiency in order to stay competitive,” Genco VP healthcare Kevin J. McPherson said. “We can better help healthcare customers, of all sizes, with their logistics challenges by offering this more flexible solution. It allows our customers to focus less on their supply chain and more on developing innovative products and services that improve the cost, quality and availability of patient care.”
The two new multi-tenant facilities are located in Memphis, Tenn. and Milton, Ontario, Canada. The Tennessee location has 1.1 million square feet of space and is located near the global FedEx Super Hub, and the Ontario location has 400,000 square feet with allocation close to the FedEx Express Canada Hub in Toronto’s Pearson International Airport. Genco said the facilities would be properly licensed to support kitting and relabeling activities.
“In today’s healthcare environment of rapid change, manufacturers need a solution that allows their supply chain costs to adapt to changing business needs,” McPherson said. “At GENCO, we understand that our customers are faced with challenges to reduce costs, maintain flexibility and improve efficiency. We’re committed to advancing our solutions and keeping an open dialogue to help our customers deliver the best patient outcomes.”
ANI launches benztropine mesylate tablets
BAUDETTE, Minn. — ANI Pharmaceuticals has launched its benztropine mesylate tablets, the company announced Tuesday. The drug is the tenth commercial introduction the company has seen in 2016, according to CEO Arthur Przybyl.
ANI’s benztropine mesylate tablets will be available in 0.5-, 1-, and 2-mg dosage strengths. The product has a current market size of about $25 million, according to IMS Health data.
GPhA outlines key GDUFA II goals at public meeting
WASHINGTON — On Oct. 21, the Food and Drug Administration held a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) II. At the meeting were various stakeholders, including the Generic Pharmaceutical Association’s SVP sciences and regulatory affairs, David Gaugh, who outlined the goals of GPhA and the FDA in negotiations over the second iteration of GDUFA.
In terms of generics access, Gaugh said the FDA will expedite the availability of generics by bringing more predictability to the process by offering eight-month priority review of critical products and 10-month review for standard products., with complex products supplying early data to be eligible for enhanced communications opportunities.
When it comes to transparency, Gaugh said that GDUFA II would enhance the FDA’s ability to protect American patients in a complex global supply environment by requiring identification of manufacturing facilities and by improving industry communication and feedback. Additionally, there will be increased transparency between companies seeking approval and the FDA through the use of information requests and discipline review letters. He also mentioned increased reporting and accountability, with such efforts as reporting requirements to enhance transparency and efficiency.
Additionally, under the five-year GDUFA II program, Gaugh said the industry would be providing the FDA with $2.6 billion in addition to the federal government’s budget authority funding to help ensure timely access to generics.
“To function most effectively, and to promote the goal of achieving first cycle approvals and approvals on the earliest legally eligible date, [the] industry focused during the negotiations on increasing transparency and communication during the review process,” Gaugh said. “Maximizing the effectiveness of the review process requires the cooperation of FDA and the generic drug industry, both of which will benefit from sharing their knowledge and concerns throughout the review. The fewer review cycles to approval, the sooner patients and payers can experience the benefits of generic competition.”
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