Warehouse Driver

Acyclovir ointment, atovaquone oral suspension, clindamycin palmitate hydrochloride for oral solution, and oxycodone hydrochloride tablets add diversity to product selection

Bridgewater, NJ (USA), August 13, 2014 – Amneal Pharmaceuticals’ fast-growing portfolio of approved generic drugs is expanding once again with the launch of four new medications.

Representing multiple therapeutic categories, these products accounted for $900 million annually in U.S. sales as of June 2014, according to IMS Health market data.

Acyclovir ointment, USP is available in 5% strength. Sold in 30-gram tubes, each gram of ointment contains 50 mg of acyclovir. The Amneal generic is an AB-rated therapeutic equivalent to Zovirax® Ointment 5%.

Atovaquone oral suspension, USP, the first-to-market generic, is available in 750 mg/5 mL strength. The bright yellow, citrus-flavored liquid comes packaged in 210 mL (8 fl. oz.) bottles. The Amneal medication is an AB-rated therapeutic equivalent to Mepron® Oral Suspension.

Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is available in 75 mg/5 mL reconstituted strength. Mixing the powder with water provides 100 mL of a clear, cherry-flavored solution. The Amneal product is an AA-rated therapeutic equivalent to Cleocin Pediatric®. Click here for full prescribing information.

Oxycodone hydrochloride tablets, USP (C-II) are available in 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg strength in 100-count bottles. The Amneal generic is AB-rated and therapeutically equivalent to Roxicodone®.

These four products are now shipping and available through wholesalers, distributors, and directly to the trade.

“Introducing these four products in the market aligns with our strategic focus on extending our generic offerings across all dosage forms,” said Chirag Patel, Co-CEO and Co-Chairman of Amneal. “Currently, we have 125 ANDAs filed with the U.S. FDA across numerous dosage forms, including transdermal, oral liquid, topical, injectable, oral solid, ophthalmic and otic. These new medications will further diversify our expansive portfolio.”

About Amneal Pharmaceuticals LLC

Amneal Pharmaceuticals LLC is a U.S.-based manufacturer of generic pharmaceuticals. Known as “Generic’s New Generation®”, Amneal prides itself on its unwavering commitment to quality, meaningful business relationships, and its innovative approach to maximizing value for all stakeholders. Extensive investment in R&D, an intelligently aggressive expansion strategy, and focus on vertical integration are key contributors to the company’s impressive growth over the past several years. Amneal is headquartered in Bridgewater, New Jersey with manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S. as well as abroad. For more information, visit www.amneal.com.

JERSEY CITY, N.J., May 21, 2014 — Co-CEO, chairman, and co-founder of one of the nation’s leading generic pharmaceutical companies, Chirag Patel, Class of ’89, will be honored with the Alumnus of Distinction Award at NJCU’s American Dream Gala to be held Thursday, June 5, 2014 in the Great Hall on Ellis Island, beginning at 7:00 p.m.

Coming to the U.S. as a young man from India, Mr. Patel never doubted that with hard work and imagination, he could be part of the American Dream.

In 2002, he and his brother Chintu started the Bridgewater-based companyAmneal Pharmaceuticals. With revenues of more than $450 million, Amneal is now the seventh largest generic pharmaceutical company in the U.S. by prescriptions dispensed.

In 2011, the Patel brothers were named theErnst & Young National Entrepreneur of the Year Life Sciences Award winners, one of the nation’s mostprestigious business awards for entrepreneurs.

“Chirag epitomizes the drive and determination we see from our students on a daily basis,” NJCU President Sue Henderson said. “We applaud his great success and his commitment to helping others achieve their own dreams.”

Mr. Patel will share center stage with two other luminaries: former Congressman Frank J. Guarini who will receive the NJCU Leadership Award for Lifetime Public Service; and Carlos Rodriguez, president and CEO of ADP, who will be honored with the NJCU Corporate Citizen Award.

The purpose of the American Dream Gala is to raise scholarship money for students planning to attend NJCU, a four-year state university with a student population of more than 8,400 undergraduate and graduate students. About 54 nations are represented in the student body. Eighty-five percent of the full-time undergraduates at NJCU receive some kind of need-based financial aid.

A deep backlog at the U.S. Food and Drug Administration is delaying approvals for thousands of generic drugs, including roughly 100 applications posted by a Long Island drugmaker.

The FDA is sorting through a long list of approval requests, with thousands of medications that could save health care providers millions of dollars – not to mention save lives – stuck in the regulatory pipeline. There were 3,400 applications awaiting review in October 2012, according to the FDA, and as of this month, the administration had only whittled that down to 2,700.

Even though those applications largely reflect variations on existing, more expensive drugs – generic versions that don’t even require clinical testing by the drugmakers themselves – they must sit in limbo until the FDA gets around to them.

That’s a bitter pill to swallow for Amneal Pharmaceuticals, which maintains Long Island operations in Hauppauge and Brookhaven.
“The majority (of our applications) are just sitting in the queue,” noted Candis Edwards, Amneal’s senior vice president of regulatory and clinical affairs. “They’re part of the backlog because of the FDA’s lack of resources.”

Amneal’s last generic-drug approval came in July, when the FDA approved the company’s Metaxalone tablets, a generic takeoff of King Pharmaceuticals’ muscle relaxant Skelaxin…

Read full article here.

Bridgewater, NJ (USA), January 9, 2014 – Amneal Pharmaceuticals LLC is pleased to announce that Rochelle Fuhrmann has joined the fast-growing generics manufacturer as Chief Financial Officer.

Ms. Fuhrmann was most recently Senior Vice President, Finance at Warner Chilcott plc. She was responsible for the oversight and direction of the finance and accounting functions including corporate accounting, financial planning and analysis, tax, treasury, risk management, and internal audit as well as investor relations. She joined Warner Chilcott in June 2006 and held positions of increasing responsibility before her promotion to Senior Vice President in January 2011.

“Rochelle’s strong leadership abilities, robust financial background, and broad industry experience bring tremendous value to Amneal as we expand our global reach in both generic and specialty pharmaceuticals,” said Chirag Patel, co-CEO and Chairman of Amneal. “We welcome her strategic vision and proactive approach and are delighted that she has joined the Amneal family.”

Prior to Warner Chilcott, Ms. Fuhrmann held various positions in finance, corporate accounting, and investor relations at AT&T Inc. She began her career at Coopers & Lybrand LLC (now PriceWaterhouseCoopers) in Boston. She holds a B.S. degree in accounting from the University of Rhode Island.

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    • Title/Position
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    • Summary:

      This position will be responsible for the movement of product between the Glasgow facilities as well as deliveries to customers in and around Kentucky and Tennessee. This position will also assist in the warehouse and other areas as needed.

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    • Summary:

      Research and development operator and technician, assist in the manufacturing of R&D trial and exhibit batches.

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    • Summary:

      This position supports Operations Department objectives by keeping production equipment operating efficiently. Performs repairs and maintenance on machines and equipment. Typically performs work in one or more of the maintenance trades: machine and equipment repair, electrical, sheet metal fabrication. , Conducts routine, periodic, of special inspections to determine repair and maintenance work necessary to prevent breakdowns of machinery and equipment. Uses hand and power tools. Tests, inspects, troubleshoots, and repairs machines and equipment. Uses blueprints, sketches, layouts, wiring diagrams, drawings, and specification. The ability to work with both Management and Production Supervision to achieve the Companies production goals. To assure that all maintenance jobs are completed in a timely, safe and responsible manner.

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    • Summary:

      The Business analyst is a dual role working between the business and IT. They reside on the business side supporting the functional groups using the Revenue Management Software. The primary focus of this role is to support the business, trouble shoot, escalate issues and act as a liaison to IT ensuring that processes and solutions that involve contract administration, commercial rebates and government pricing are working as configured.

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      Responsible for setting up coating machine, operating and tending machines to coat product.

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    • Summary:

      Make sure IPQA process followed properly. Check and ensure that Compression Operations are performed as per SOP. Check tablets parameters hourly in compression from every machines. Check the data entered in PBR by operators to avoid errors. Check RPM of all running machines to optimize production out put. Reduce equipment cleaning time . . .

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    • Summary:

      The Setup Mechanic is primarily responsible for coordinating and performing routine changeovers of Amneal’s GMP process manufacturing equipment in order to maintain critical production schedules.

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      This position will be reporting in to Legal while supporting and being an integral member of the Sales and Pricing departments, this individual will draft and review contracts for sale of products, including all product amendments and volume rebates under the supervision of Sales, Pricing and Legal. Responsible for company compliance with contract terms.

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    • Summary:

      Handle customer complaints (quality/technical and adverse events, product/technical and medical inquiries) through telephone, fax, emails, and mails in a manner compliant with cGMP, FDA regulations and guidance, company’s Standard Operating Procedures (SOPs) and practices.

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    • Summary:

      Reporting directly to the CEO, the Executive Assistant provides administrative support in a one-on-one working relationship and serves as the primary point of contact for internal and external constituencies on all matters pertaining to the Office of the CEO.

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      In charge of electrical work in the installation, alteration, maintenance, and repair of electrical systems, equipment and fixtures in accordance with standard practices of the electrical code.

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      The Maintenance Mechanic keeps the  facility up and running and helps prevent breakdowns of critical utilities. In addition, this positions supervises the janitorial work.

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    • Summary:

      The Government Pricing Analyst is responsible for the monthly calculation of AMP and for variance analysis, trending and outlier reviews.

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    • Summary:

      Inspect, modify, repair and install HVAC equipment. Conduct regular preventive maintenance for HVAC. Repair & rebuild compressors. Carry out facility repair, maintenance and construction activities. Train and guide coworkers and work as a team. Follow company’s SOPs. Install HVAC systems, exhaust fans, dust collectors and other mechanical systems. . .

      Details »
    • Summary:

      Inspect, modify, repair and install HVAC equipment. Conduct regular preventive maintenance for HVAC. Repair & rebuild compressors. Carry out facility repair, maintenance and construction activities. Train and guide coworkers and work as a team. Follow company’s SOPs. Install HVAC systems, exhaust fans, dust collectors and other mechanical systems. . .

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      Responsible for proper operation of company forklifts, loading and offloading of trucks and visual inspection of trucks and freight.

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