Issue link: http://osercommunicationsgroup.uberflip.com/i/562595
C h a i n D r u g s t o r e D a i l y Tu e s d a y, A u g u s t 2 5 , 2 0 1 5 6 6 LNK: A FOCUS ON QUALITY For LNK International Inc., which spe- cializes in manufacture of private label over-the-counter pharmaceuticals and contract manufacturing, a focus on quali- ty is in the company's DNA. "Quality will always keep your product on the shelf," said Joseph Mollica, Chief Executive Officer and Founder of LNK. Many firms say they are committed to delivering quality products, but LNK officials say that at their company, it is embedded in their corporate fabric. For LNK President, Pankaj "PK" Chudgar, the ability to oversee all areas of the manufacturing process and the packaging process means that quality standards are built into each step. More than 15 percent of LNK's staff is dedicat- ed to quality control and quality assur- ance. "I think that most would agree that a solid quality program costs a fraction of what a recall will cost," said Chudgar. Historically, LNK has focused on producing only high quality products. For example, LNK decided to keep the com- pany focused on over-the-counter phar- maceuticals. This approach has allowed the company to concentrate on what it knows best and does very well for over 35 years. LNK specializes in over the count- er pharmaceutical products, specifically solid-dose analgesics, cough/cold/aller- gy/sinus and gastrointestinal products, and offers more than 140 pharmaceutical formulas in these areas. In answer to its customers' repeated requests to enter the liquid market because of a void of quality liquid sup- pliers, LNK has entered into liquids and semi-solid dosage forms, now offering the industry the same quality and reliabil- ity it has come to know from LNK. As a prime manufacturer, LNK con- trols every step of the production process, from the acquisition of raw materials through the manufacturing and distribu- tion of finished products. By controlling all aspects of production, LNK is able to control the quality and keep costs low. LNK produces 99 percent of the products in its facilities in Hauppauge, N.Y. Working directly with the manufac- turer is a real advantage for LNK cus- tomers that seek to create a brand, because it allows them to be certain that the products will be of uncompromised quality. As a prime manufacturer, LNK can maintain the integrity of its cus- tomers' products. Working with a prime manufacturer also creates significant advantages for the retailer or national brand client, as the flexibility exists at the manufacturing level to adjust to certain market conditions at a moments notice. "At LNK, quality is taken very seri- ously, as it is the foundation for everything we do. Our client's relationship with their customers is taken seriously and quality is the key," said Doug Bausch, Vice President of Sales and Marketing. "As a private brand and contract manufacturer, the repu- tation of our customer is on the line every- day as well as our own reputation." The payoff from this strategy of remaining prime and maintaining a com- mitment to quality is the fact that LNK is one of the largest private label manufac- turers of O-T-C solid dosage products in the United States. The company has grown steadily over the past 35 years due to the trust that it has earned from its national and inter- national customers, as well as from the increased awareness and satisfaction consumers have regarding the quality of private label brands LNK manufactures. LNK continues to invest in FDA fil- ings and state of the art manufacturing equipment resulting in the manufacture of new quality formulas and products. For more information, visit www.lnk intl.com, call 631.435.3500 or email dbausch@lnkintl.com. MUCH SHELIST: SOPHISTICATED HEALTH CARE LAW SERVICES An interview with Ned Milenkovich, PharmD, Juris Doctor, Principal with Much Shelist CDD: Tell our readers about Much Shelist. NM: We are a highly sophisticated team of health care attorneys with a particular emphasis on drug and pharmacy law. While Much Shelist is an established full- service law firm founded in 1970, when my team of healthcare lawyers joined, we brought added experience and understand- ing in the health care legal space. We understand the laws and regulations that healthcare enterprises face in all aspects of their businesses and uphold a standard of providing high-quality, exceptional and pragmatic legal advice. In addition, Much Shelist has nearly 100 attorneys who prac- tice in many other areas of the law, includ- ing labor and employment, intellectual property, complex litigation and corporate transactions, just to name a few. CDD: What kind of legal challenges do health care enterprises face? NM: Today's health care enterprises face a number of legal challenges, including regulatory compliance issues, private party litigation, payor contract issues, transactional matters (such as mergers and acquisitions), and defending against both federal and state government inves- tigations. With our understanding of legal issues in general, and drug and pharmacy law specifically, we are ready to provide trusted advice in all of these areas. CDD: Who in the health care industry will benefit most from Much Shelist's services? NM: Our firm has strong general health care experience as well as an in-depth understanding of drug and pharmacy law, and we represent all entities along the supply chain. We represent manufactur- ers, wholesale distributors, third-party logistics providers, pharmacies and tech- nology companies. As trusted legal advi- sors, we provide top legal counseling and advice that our clients can depend on time and again. CDD: Can you tell us how your history in health care helps you bring optimal service to your clients? NM: Well, I am a pharmacist and an attor- ney and I understand health care, specifi- cally drug and pharmacy law. I practiced pharmacy for almost 10 years, having worked as a licensed pharmacist in hospi- tals as well as in the retail setting. I received my pharmacy degree from The Ohio State University, a Doctor of Pharmacy from the University of Illinois and a law degree from The John Marshall Law School. Currently, I am in my second term as vice-chair of the Illinois State Board of Pharmacy. I also write a monthly legal and regulatory column in the nation- al magazine "Drug Topics." I know how healthcare works in practice and the legal challenges that arise with managing and bringing healthcare services to market. CDD: Is there anything else you'd like to tell our readers? NM: Much Shelist is a full-service law firm with a nationally known drug and pharmacy law practice. We understand the legal challenges that clients face and we advocate on behalf of our clients every day. For more information, contact Ned Milenkovich, PharmD, JD at nmilenkovich@muchshelist.com or call 312.521.2482. PRODUCT CAPABILITIES DRIVE AMNEAL'S NEXT PHASE OF GROWTH Amneal Pharmaceuticals LLC is taking the next step on its path of phenomenal growth by aligning resources to maintain the supe- rior quality of its generic drugs even as it expands into new dosage forms and mar- kets. All 11 of the company's state-of-the- art manufacturing plants worldwide are certified to exacting U.S. FDA cGMP stan- dards. Five expansive U.S. and interna- tional research and development centers house Ph. D and M. D. level scientists with multi-disciplinary backgrounds in intellec- tual property, regulatory, clinical, medical affairs, process technology, engineering and other disciplines. In addition to a large, diversified portfolio of 82 approved generics, Amneal also counts 214 pipeline prod- ucts currently in development and 122 pending FDA approval. The company has established commercial capabilities with dedicated teams and operating units to develop, manufacture and market eight different dosage forms efficiently. Oral solids are Amneal's best-known medications in tablets, caplets, softgels and new oral thin films that include 83 products filed or in development with a US market value of $34 billion dollars, according to IMS Health. Abuse deter- rent systems are being developed to make dosage forms difficult to manipulate or abuse through crushing, drug extraction or exposure from intentional or acciden- tal overdose. Amneal understands the best meth- ods of handling dosage forms like oral liquids, that comprise of solutions and suspensions, and the $3.2 billion market in topicals, including solutions, oint- ments, gel and creams, to ensure quality in every product. The $4.2 billion transdermal market includes hydrogel and matrix patches and form-fill seals while inhalation forms such as Dry Powder Inhalers (DPIs) with multi-component, highly-sophisticated designs and Metered Dose Inhalers (MDIs) whose complex design requires precision engineering for pumps, meter- ing valves and dose counters, are impor- tant patient aids. Injectables for general purpose and oncologic therapies include products such as microspheres and pen devices that can help patients manage chronic conditions. Microspheres deliver a cus- tomized, sustained release of proteins, peptides and other medical components for extended treatment regimens while pen injection systems offer convenience and compliance support for patients as well as time and cost savings for health- care providers and payers. Intranasal dosage forms like sprays and solutions and otics, ophalmics and transucosals, along with other niche dosage forms, round out the complex system of dosage forms that Amneal Pharmaceuticals has experience working in. The unique products involve com- plex molecules and high-precision devices with difficult formulation, process and manufacturing requirements plus a complicated regulatory pathway. It is a high barrier-to-entry segment with numerous first-to-market "whitespace" opportunities where there is no generic penetration. With 21 of Amneal's injectable prod- ucts in the pipeline representing a market size of $12.6 billion dollars, the company plans to support its current portfolio and extensive pipeline of future products by investing more than $600 million in research and development as well as cap- ital expenditures over the next two years. When facility expansions are completed, finished products manufacturing space will exceed one million square feet with an output of approximately 30 billion units annually. Amneal's strategic decision to focus its business resources on each dosage form it supplies is just the latest example of how the company pursues "intelligent growth." This alignment results in strong commitment and execution in each cate- gory, as well as employees' ownership of success, to ensure the consistently superb product quality and outstanding service levels for which this generics industry leader is known. For more information, go to www.amneal.com or call 866.525.7270.