Delivering In Detail
While clients’ quality, cost and speed demands must be met; today’s regulatory environment emphasizes the importance of partnering with a contract manufacturer that can help a company confidently go to market.
Every company, regardless of size, has one goal: to be bigger. To grow its product lines, its market share, its customer base and, ultimately, its sales.
Contract manufacturers are in a unique position because they, too, must grow, but expansion in equipment, ingredient availability and knowledge, testing capabilities, marketing assistance, etc., is needed to anticipate and accommodate customers’ ambitions.
While cost, speed, flexibility and quality remain top priorities of companies seeking a contract manufacturer, in today’s increased regulatory environment, those concerns have to be tempered— the right partner will deliver on all those fronts, but more importantly will provide the documentation and substantiation necessary to go to market.
“Our clients want quality products at low prices delivered within short lead times. While one of our first priorities is unparalleled customer service, given the regulatory landscape, lead times are often much longer than clients would prefer,” said Shabbir Akand, director of marketing with NHK Laboratories, a fullservice contract manufacturer and packager of dietary supplements based in Santa Fe Springs, CA. Its client base ranges from relatively large, publicly held companies to small, sole proprietorships that approach the company because they need private label dietary supplement supply chain solutions.
Akand explained that while smaller firms are increasingly more sophisticated, he’s observed that larger clients typically understand the operating cycle of a contract manufacturer. “Moreover, larger firms typically conduct a fair amount of due diligence, which often includes physical plant audits and execution of legal contracts. Accordingly, these larger firms typically approach us well in advance of their required delivery date.
“As a quality-conscious and forwardthinking contract manufacturer, we have made multi-million dollar investments in plant automation, laboratory equipment, training and world-class personnel to improve process efficiency.”
Ed Kinon, marketing manager with Pacific Nutritional Inc. (PNI, Vancouver, WA), shared that the regulatory environment has been a considerable equalizer for the industry. “Due to current government regulations, both small and large clients need the same information and service,” he said. “The only real difference is that larger companies have larger volume needs.”
GMP Demands
The most common requests coming to PNI pertain to product development assistance and quality control processes but one question that is increasingly asked involves Food and Drug Administration (FDA) good manufacturing practices (GMP) compliance. “We alleviate the concern by providing the NPA’s GMP certification,” said Kinon. “By demonstrating our processes and documentation methods, we assure our clients’ products are in complete compliance with regulations.”
Companies of all sizes seek out Bridgeport, CT-based AnMar International’s granulation, blending and trituration of vitamins, amino acids and herb extracts. As John Blanco, the company’s president, pointed out, today’s customers, regardless of size, shares similarities.
“[Companies] are similar in that they all want expected delivery times met and consistent quality of products supplied with manufacturing protocol and validation of the process methods,” said Blanco.
AnMar establishes a protocol that takes into consideration the customer specification, testing needs as well as a manufacturing protocol for each customer’s product(s). Third-party testing is done at accredited laboratories to assure clients that the products meet their specifications. But Blanco said there are two major concerns that the company has worked to alleviate for its clients: content of the ingredient that is granulated/ diluted, and microbial contamination.
“In the first case, AnMar adds a two percent overage to ensure conformity that product meets specifications, plus identity of raw material and finished product, with final assay,” he explained. “In terms of microbial contamination, we have established standard operating procedures that conform to GMP requirements and personnel are trained in procedures relevant to their tasks. This ensures the quality, safety and purity of our products. We also provide results of microbial testing of our products.”
Regulatory compliance is part-andparcel of NHK’s corporate mission and culture, said Akand. “We were one of the first firms to receive NNFA’s GMP certification in 2001, and we were the first firm to receive NSF’s GMP 9000 certification,” he said. “We continue to be certified by NPA and NSF GMP, and we are still ISO 9001:2011, in addition to being halal and organic certified. All of these credentials translate to proof of a company-wide commitment to quality control systems and procedures.”
Sabinsa (East Windsor, NJ) has a regulatory department in place, especially for its international clients. “The paperwork to send finished dosage forms abroad is almost a complete dossier with regard to the ingredients that have been used and the manufacturing process itself. We also provide documentation on all certifications that the plant has,” said Shaheen Majeed, the company’s marketing director. “With our U. S. clients, we have in-house legal ability to vet some of the disclaimers and we try to be pretty conservative. Marketing companies do often push those boundaries, however, in today’s world, we realize both the marketing company and the manufacturer are responsible.”
Testing
Jay Kaufman, president of Paragon Laboratories (Torrance, CA), a contact manufacturer that has more than 40 years of experience manufacturing and packaging dietary supplements, expressed that with the advent of GMPs, his company has been prepared to meet the testing demands of its clients.
“Our clients are all very quality conscious.We are here to help meet their supply chain needs and protect their brand equity,” he said. “Since the implementation of GMP’s for dietary supplements, there is higher demand for testing of finished product and raw materials over that which existed in previous years. We help meet the customer needs by working closely with them to clearly establish the finished product specifications and price points they are looking to have met. We then use either existing methods and/or sometimes develop new tests in order to confirm that those specifications are being met.”
Paragon is GMP certified from both NSF and NPA, and offers a full in-house laboratory that has in-house microbiological capabilities and is staffed with PhD-level scientists. “Our operation stands out because of our high level of technical expertise, multiple certifications and organic capabilities,” said Kaufman, adding that the company offers unique packaging capabilities beyond bottles, such as packets, pouches, blister cards and stick packs.
NHK houses four state-of-the-art laboratories, which are equipped with myriad analytical instrumentation capable of quantitative and qualitative testing, including various types of chromatography and microbiology. “Our laboratory includes several highly trained scientists and technicians, many of whom have multiple graduate degrees in the fields of nutrition, biochemistry and chemical engineering,” said Akand. “If, however, a product requires testing that is unavailable internally, we work with some of the leading third-party laboratory firms in the country.”
Sabinsa offers in-house testing for analytical, chemical and microbiological, which Majeed pointed out offers a prime advantage. “We do not need to send out for any of these, and so not only are those costs are saved, but we know the results will be accurate,” he said. “Plus, we do have stability chambers in place, both real time and accelerated, for testing of the finished goods. We plan on increasing the number of chambers in the years to come.”
Wielding Ingredients
As a supplier of many of the natural extracts that are used in the dietary supplement industry, most companies come to Sabinsa for many of the intermediate steps before taking the material to the final encapsulation/tableting phase. “These may include blending a couple of our ingredients together; milling to certain particle sizes and helping them granulate their ingredients for ease of handling when it come to tableting,” said Majeed. “No one knows better than we do as to how to blend, mill, granulate and eventually encapsulate and tablet our ingredients. Most marketing companies are not aware of, and most contract manufacturing companies often do not disclose, special handling needs for individual products until after problems have already surfaced.”
Sabinsa just introduced an innovative selection of Integrated Nutritional Composites™ (INC): bi-layered, multirelease nutritional compositions targeting specific health maintenance needs. Carefully formulated, these compositions deliver stable dosage forms of actives that may not otherwise be compatible, or are difficult to formulate. These ready-made formulations, many of which include Sabinsa’s sciencebased, patented ingredients, are available in high demand categories such as weight management, heart health and joint support, according to Majeed, adding that the company can also work with customers to develop unique formulas.
In addition to offering an established stable of patented and branded ingredients, Sabinsa can also help perform a clinical study using these ingredients through ClinWorld. “Independently setup in Mumbai, India, ClinWorld has access to doctors, patient beds and research centers for human clinical trials,” explained Majeed. “Imagine a scenario where you have a unique formula, backed with patented and branded ingredients and a clinical study on that formula … we can make that happen.”
NHK works with proprietary ingredient suppliers regularly, according to Akand, and the company is often aware of new research results before the general public. “We utilize this lawfully obtained intelligence to improve our clients’ market position by recommending formulations that leverage and capitalize on the latest research studies,” he said. “Our manufacturing capabilities also include specialty tablet sizes, shapes and colors, which are often critical to brand identity. We also work with several local label printers and specialty contract packagers that can help our clients establish a recognizable shelfpresence.”
Going to Market
Randal Optimal Nutrients (Santa Rosa, CA) has been a private label and custom manufacturer of dietary supplements to the health food industry since 1947. Lauren Clardy, vice president of marketing and business development, noted there have been increased requests for GMP certified/approved products and services, but what her company hears requested more often from clients is for hands-on assistance bringing a product to market and making it stand out.
“Key concerns are assistance with marketing, positioning and formula development as well as design and label assistance,” said Clardy, adding that the company offers a GMP certified facility, digital printing, advanced formulation and marketing expertise, as well as the ability to respond quickly to trends in the market.
“Randall offers a suite of value added services to help our clients get to market from formulation assistance, marketing, branding, design services, marketing collateral, technical and regulatory assistance, fulfillment and international shipping,” she said. “Our design service team is ‘second to none’ and we feel one of the best in the industry.”
As a company that typically caters to small- to mid-sized companies, one of Randall’s strengths is its small run size, as well as the fact that it carries over 400 stock formulas for private label. “This separates us from the many contract manufacturers that don’t have private label items in stock or have a very limited selection,” said Clardy, adding that the company’s manufacturing facility follows strict cGMPs and maintains full quality control from “seed to shelf” to ensure clients’ products meet or exceed specifications.
“We have experience with multi-level and direct marketers, retail stores, wholesale and global distribution for vitamin and mineral cutting-edge formulas, herbal supplements, botanicals, sports nutrition products and nutraceuticals,” she concluded. “From concept to finished product, Randal’s’ technical and marketing staff can help make a product a success.”
