Sr Director of Quality Management

Authorized Generic offers brand product plus patient savings

Bridgewater, New Jersey (USA), November 20, 2014 – Amneal Pharmaceuticals LLC (www.amneal.com) today announced the launch of Lopreeza™ (estradiol/norethindrone acetate) tablets in 0.5 mg/0.1 mg and 1 mg/0.5 mg strengths. Amneal’s product is the first Authorized Generic of the brand, Activella®, containing the identical formulation of estradiol/norethindrone acetate.

“With an Authorized Generic like Lopreeza™, pharmacists are able to provide their patients with the same brand products at a lower cost,” states Amneal Co-CEO Chirag Patel. “Consistency is critical in this therapeutic category. Women currently taking Activella® can now enjoy continuity of therapy by remaining on the brand product while benefiting from the generic savings.”

Both strengths of Lopreeza™ are now shipping. The tablets are sold in 28-count dialpack dispensers and available through wholesalers, distributors and directly to the trade.
Annual U.S. sales of estradiol/norethindrone acetate tablets were $116 million as of August 2014, according to IMS Health.
Click here for full prescribing information.

 

Chintu and Chirag Patel honored for commitment to local philanthropy

Hauppauge, NY (USA), October 27, 2014 – Amneal Pharmaceuticals LLC, one of the largest U.S. manufacturers of generic drugs, is proud to be the recipient of the 2014 Long Island Cares Corporate Honoree Award. Brothers Chintu and Chirag Patel, Co-CEOs and Co-Chairmen, will accept the award on behalf of the company at a cocktail reception and formal dinner on Wednesday, November 5 at the Crest Hollow Country Club in Woodbury, New York.

“We deeply appreciate this recognition for Amneal’s community efforts from Long Island Cares,” said Chintu Patel. Chirag added, “We truly believe in sharing the benefits of our success by giving back to the areas in which we do business.”

The Patels have remained true to their values – a focus on quality across all company operations, respect for the highest standards and ethics and total commitment to customers, business partners and employees – while treating their colleagues and staff like family. They are dedicated to both their successful, growing enterprise and to supporting many charitable causes in the community.

Active in the HIA-LI since 2010, Chintu and Chirag have supported Long Island Cares through numerous food drives and participation in the annual golf classic and awards dinner as well as the Long Island Association, Make-a-Wish Foundation, Habitat for Humanity, the educational non-profit KaBOOM!, Toys for Tots, New York Blood Center, American Cancer Society breast cancer walks and a Hurricane Sandy clothing and food drive.

Amneal was founded in 2002 by Chintu and Chirag with support from their father, Kanu Patel. The company operates nine state-of-the-art manufacturing plants in New York, New Jersey and India and employs over 2,600 worldwide. Amneal is investing more than $400 million in research and development and capital improvements, including a major expansion at the Brookhaven, New York production facility.

The generics maker has won numerous industry awards for product and service excellence as well as outstanding business growth. Earlier this month Amneal received the global “Company of the Year” Award at the Global Generics & Biosimilars Awards 2014 in Paris, France in recognition of its rapid growth in North America.

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.

 

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Amneal Senior Vice President of Regulatory/Clinical Affairs Candis Edwards will be a featured speaker at the Generic Pharmaceutical Association’s Fall Technical Conference in North Bethesda, MD being held October 27-29.  Ms. Edwards will address industry concerns regarding the Controlled Correspondence process utilized by the Office of Generics Drugs to provide information on a specific element of generic drug product development at the Pre-Conference Breakout Session on Monday, October 27.

The GPhA Fall Technical Conference attracts over 700 attendees and allows the generic industry to stay abreast of the latest regulatory, legal and technical developments as well as FDA’s progress on ANDA reviews and other important issues for FDA and industry stakeholders.

Leading generics maker is recognized for exceptional growth

Bridgewater, NJ (USA), October 21, 2014 – Amneal Pharmaceuticals LLC is pleased to announce that the company has won the “Company of the Year” Award from Generics bulletin, a newsletter which provides commercial and regulatory information for the global generics and biosimilars industries. Presented on October 7 at the Global Generics & Biosimilars Awards 2014 held in Paris, France, the award recognizes Amneal’s rapid growth in North America.

Amneal is the 7th largest U.S. generics manufacturer based on prescriptions dispensed, according to IMS Health. The company’s 76 FDA-approved generic medications and robust pipeline of 264 products filed with the U.S. FDA or in development cover a broad range of therapeutic categories. In addition to high-volume commodity medicines, Amneal’s portfolio contains many high-barrier-to-entry and difficult-to-formulate products and spans almost the entire range of dosage forms in the market.

To produce the highest quality generic medications for its customers and accelerate its incredible growth, Amneal is making major investments in research and development, infrastructure, and human capital. The company will spend more than $400 million on R&D and capital improvements to its nine manufacturing plants in the U.S. and India over the next two years. Amneal has also invested considerable resources in human capital as well as product development and now employs over 2,600 worldwide.

In addition to its U.S. operations, Amneal is expanding internationally by establishing front-end marketing and distribution capabilities in UK, Spain, Germany, the Nordic countries, Switzerland, and Australia. The company is also pursuing acquisitions and evaluating strategic partners in Japan, Southeast Asia, and Latin America.

“We are deeply honored to be recognized as ‘Company of the Year’,” said Amneal Co-CEO and Co-Chairman Chirag Patel.   “This award lets us know we’re doing all the right things to run a successful, growing enterprise while remaining true to our values – dedication to quality across all operations, maintaining our high standards and ethics and total commitment to our customers, partners and employees.”

 

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.

Newly-leased space in Glasgow will nearly double size of current operations

Bridgewater, New Jersey (USA), September 23, 2014 – Amneal Pharmaceuticals LLC, one of the largest generic drug suppliers in the U.S., has signed a lease for a second location in Glasgow, Kentucky that will nearly double the size of its national sales and distribution center.

Tony Hodges, Vice President for Global Logistics, discussed Amneal’s latest growth plans in the state at a Glasgow-Barren County Chamber of Commerce breakfast on September 12. The company was honored as the 2014 Industry of the Year, chosen by Chamber members, during the event.

Amneal acquired the lease at 40 Aberdeen Drive in the former Carhartt Building from Aphena Pharma Solutions, a medication packaging firm and Amneal supplier, which announced it will cease operations in Glasgow at the end of the month. The building will be refurbished to create a 120,000 sq. ft. warehouse and 6000 sq. ft. of offices to support logistics. When the expansion is complete, the company’s Glasgow operations will occupy a total of 221,000 sq. ft.

Glasgow-Fig1---Space

Since 2007, Amneal’s Kentucky sales and distribution capabilities have grown dramatically (see Figure 1). Upon acquiring Akyma Pharmaceuticals that year, the company moved into its 3000 sq. ft. offices at 104 Hippocrates Way and 30,000 sq. ft. warehouse in nearby Fountain Run. In 2010 Amneal consolidated distribution logistics and sales operations in-state rather than relocating these critical functions near its headquarters and manufacturing plants in metro New York by leasing a much-larger 115,000 sq. ft. facility at 118 Beaver Trail.

Amneal has invested over $6.6 million in Glasgow and created jobs for 80 Kentuckians to date, exceeding this year’s goal. Figure 2 shows actual employment growth from 2008-2014.

Glasgow-Fig2---Employees

Once the Aberdeen Drive expansion is complete, the generic maker will employ over 90 local residents.

For its earlier project, Amneal secured multi-year tax incentives through the Kentucky Economic Development Finance Authority (KEDFA) and the Kentucky Business Investment (KBI) program. The company also obtained an economic development loan from the Glasgow/Barren County Industrial Development Economic Authority, forgivable if agreed-upon headcount growth commitments are met. The KEDFA/KBI grant and Glasgow/Barren County loan were key factors in Amneal’s decision to remain and expand in Kentucky.

Although the financial incentives Amneal has received over the past several years are important, the company is also reaffirming its commitment to Glasgow due to its people.

“From our first opportunity to get to know Akyma’s employees prior to acquiring that business, we have been impressed with the work ethic, integrity, common sense, commitment to success and positive attitude of Kentucky’s citizens,” said Jim Luce, Amneal’s Executive Vice President-Sales & Marketing, who oversees the entire Kentucky operation. “The economic incentives definitely played a critical role in our decision to continue growing in Kentucky, though incentives and nice buildings aren’t worth anything without superb people. And finding all three in Glasgow, it was easy to commit our long term future here.”

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 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.

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Click here to download a PDF of the press release.

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.

Click here to download the full release in PDF format.

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.

Click here for full release.

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
    • Location
    • Department
    • Summary:

      Set up and execute policies designed to economically assure that Amneal remains compliant with GMP regulations, that its products meet the highest standards of quality, and that customer service goals are met

      Details »
    • Summary:

      To process and analyze customer chargebacks on a daily basis and to provide customer response regarding any chargeback discrepancies.  Utilizing a background in finance, credit or accounting, we are looking for a candidate who can work through a variety of duties and maintain accuracy and professional service to our customers.

      Details »
    • Summary:

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

      Details »
    • 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 . . .

      Details »
    • Summary:

      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.

      Details »
    • 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.

      Details »
    • 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.

      Details »
    • Summary:

      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.

      Details »
    • Summary:

      Responsible for ensuring proper functioning of machinery, equipments and utilities and overseeing the following programs: validation, calibration, PM, BM, Pest Control, Environmental & Safety, parts procurement and management, permits maintenance, sanitization, engineering SOPs implementation and training

      Details »
    • Summary:

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

      Details »
    • Summary:

      Maintains and repairs facilities and all types of utility equipment.

      Details »
    • Summary:

      The Scientist I will support the team of scientists and contribute the formulation development of the drug products intended for regulatory registration.

      Details »
    • Summary:

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

      Details »
    • Summary:

      Reporting to the Vice President of HR, the HR Specialist will assist with the development of policies and programs to attract, retain and promote a diverse work force for the organization. In addition, will assist with the development of policies and programs to attract, retain and promote a diverse work force for the organization.

      Details »
    • Summary:

      HRIS Clerk for the Human Resources department of our office located in Hauppauge, NY.  This position is responsible for the maintenance of the company’s human resource information system.

      Details »
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