Issue link: https://www.e-digitaleditions.com/i/571156
In other news, an IPEC-Americas rep- resentative delivered a presentation and offered comments at the FDA's public meeting seeking input on the reautho- rization of the Generic Drug User Fee Amendments (GDUFA). Key issues included the review and qualification of novel excipients, improving the inactive ingredient database, and how to refer- ence families of related excipients in ANDAs. Hikma to acquire Roxane Labs LONDON, UK—Hikma Pharmaceu- ticals agreed to buy Roxane Laborato- ries, Columbus, OH, a specialty gener- ics manufacturer, for about $2.65 billion in cash and stock. The acquisition will broaden Hikma's manufacturing capa- bilities to include solids, liquids, nasal sprays, and powder inhalers. It also will establish Hikma as the sixth-largest US generics company. Roxane is a unit of Boehringer Ingelheim. Perrigo to acquire Naturwohl Pharma DUBLIN, Ireland—Perrigo agreed to acquire Naturwohl Pharma, which owns Yokebe, Germany's second- largest-selling dietary supplement brand. The move follows Mylan's bid made in April to acquire Perrigo for $32.7 billion. Briefly noted… The FDA approved Rexulti (brexpipra- zole) tablets to treat schizophrenia and serve as an adjunct to standard antide- pressants to treat major depression. The medication was developed by Otsuka Pharmaceutical America, Rockville, MD. Teva Pharmaceuticals, Tel Aviv, Israel, is the first applicant to receive FDA approval to market generic almotriptan malate 6.25- and 12.5-milligram tablets in the USA. Almotriptan, prescribed to treat acute migraines, was developed by Janssen Pharmaceuticals and sold under the brand name Axert. industry news Draft Guidances address dissolution testing, quality metrics SILVER SPRING, MD—The FDA issued the draft Guidance, "Dissolution Testing and Specification Criteria for Immediate-Release (IR) Solid Oral Dosage Forms Containing Biopharma- ceutics Classification System Class 1 and 3 Drugs." It provides recommenda- tions intended to simplify dissolution test methodology and facilitate reviews of NDAs, INDs, and ANDAs for IR tablets and capsules containing highly soluble APIs. The Agency also pub- lished a draft Guidance titled "Request for Quality Metrics" that outlines its plans to improve inspection outcomes and minimize drug shortages by requir- ing quality metrics information from manufacturers. FDA approves first 3D-printed drug product BLUE ASH, OH—Aprecia Pharmaceu- ticals received FDA approval for Spri- tam (levetiracetam), an adjunctive med- ication for seizure disorder, which the company manufactures using three- dimensional (3D) printing, also known as additive manufacturing. The tablet is made using the company's ZipDose technology to create a porous formula- tion that rapidly disintegrates with a sip of liquid. The technology delivers a drug load of up to 1,000 milligrams in a single dose and requires no measuring. It is the first drug product made via 3D printing to receive FDA approval. IPEC-Americas takes position on accelerated stability studies, GDUFA ARLINGTON, VA—IPEC-Americas released a position paper addressing the necessity of accelerated stability studies of excipients for which long-term sta- bility data is already available. The paper can be found at bit.ly/Excip- Stab15. markets Contract manufacturing market projected to reach $84 billion by 2020 BANGALORE, India—The global phar- maceutical contract manufacturing mar- ket, valued at $58 billion in 2014, is pro- jected to reach $84 billion by 2020, a 6.4 percent compound annual growth rate, according to a report by Mordor Intelli- gence. The expected growth is primarily attributed to pharmaceutical companies focusing on in-house R&D and outsourc- ing manufacturing and packaging of fin- ished products. The report examines mar- ket segments by dosage form and geographical region, identifies micro and macro factors that influence global and regional markets, and profiles the major companies according to their strategic initiatives and market shares. It costs $4,250, Report assesses pharmaceutical anti- counterfeiting technology DUBLIN, Ireland—Counterfeit drug products are a public health hazard and endanger safety, and a report from Research and Markets examines the key features of known and emerging anti- counterfeiting technologies. "Pharmaceu- tical Anti-Counterfeiting Technologies Market 2015-2025" offers a scenario- based future market outlook and exam- ines the challenges unique to the phar- maceutical industry. It also includes two case studies on serialization. The cost is $2,199. US pharma chemicals demand to approach $54 billion by 2019 CLEVELAND, OH—US demand for pharmaceutical chemicals is expected to increase 6.1 percent annually to $54 bil- lion in 2019, according to a report from the Fredonia Group. Sales to generic drug companies will factor prominently in nearly one-third of this total. The remainder comprises pharmaceutical chemicals produced in-house or con- tracted for use by manufacturers of pro- prietary drug products. The introduction of new therapies with better efficacy will drive the gains. In addition to growth due to new molecular entities, the growth in sales of proprietary pharmaceutical chemicals will benefit from prescription- to-OTC switches, which increase demand. The report, "Pharmaceutical Chemicals," costs $5,200. 8 September 2015 Tablets & Capsules