FALL 2017

 

 

 

 

 

 

 

FEATURE

 

WHAT IS SERIALIZATION? 

 

 

A few years ago Congress passed The Drug Quality and Security Act (DQSA), in an effort to provide electronic traceability for prescription drugs. The Act will help to enhance the FDA's ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. This requirement for electronic traceability has required CMO's to implement new serialization systems to track drugs down to the unit dose level. Now, several years after the Act has passed, many CMO's do not have the systems in place to support serialization of products. The lack of implementation amongst manufactures was so widespread that in June the FDA decided to delay the requirement of serialization until November of 2018.

 

Pharma Tech Industries has successfully implemented serialization and will be shipping its first lots of serialized products by the end of October. Pharma Tech has partnered with Adents to provide both the pilot and supervisor software systems for Pharma Tech's production line and site level serialization system. Using a remote carton printing operation, Pharma Tech is able to serialize from the pallet level down to the individual dispensed unit level. Adents software systems integrate with our customers' serialization systems to create a solution that is fully compliant with the FDA serialization requirements. By the beginning of Q1 2018 Pharma Tech will be shipping serialized finished goods for two RX product lines.

 

 

GROWING MARKET OPPORTUNITY - NUTRITIONALS

In June of this year, Pharma Tech became a voting member of the Council For Responsible Nutrition ("CRN").  CRN is the leading trade association for the dietary supplement and functional food industry.

 

CRN is a highly-respected, trusted source of information on dietary supplements and functional food issues for federal, state and local lawmakers. Serving as a strong voice for its member companies, CRN advocates for reasonable solutions that enable the industry to innovate and grow while also serving the interests of consumers who want access to a variety of high quality, beneficial and safe dietary supplements. With more than 170 million Americans taking dietary supplements every year, dietary supplements are mainstream products that help promote health and wellness.

 

According to the 2016 CRN Consumer Survey on Dietary Supplements, more than 170 million Americans take dietary supplements.  People 55 and older are the largest group of users of dietary supplements with 74% of survey responders acknowledging their use of dietary supplements.  Surprisingly, two other age groups 18-35 and 35-54 year olds also report usage of 70%.

 

Economically, the dietary supplement industry has been creating good paying jobs for decades. Dietary supplement manufacturers and ingredient suppliers operate in all 50 states. According to an independent analysis funded by CRN and conducted by John Dunham and Associates, the industry is a major economic engine successfully employing more than 750,000 Americans and generating $5.75 billion in state and local taxes-money that helps build and supply schools, police and fire departments, roadways and other projects-and $9.2 billion in federal taxes. In the United States, the dietary supplement industry's overall economic impact in 2016 is $122 billion and it continues to grow. Much of this growth has been driven by an increase in consumer demand for health and wellness products.

 

You may wonder why Pharma Tech has chosen to join CRN.  Since 2013, Pharma Tech has been making dietary supplement and medical food products for its customers.  Dietary supplements are regulated products that are governed by the Food and Drug Administration.  Our customers have come to Pharma Tech because of our compliance with Food and Drug regulations and our track record of making quality OTC and Rx pharmaceutical products.  As the dietary supplement market has grown and has drawn more regulatory attention, Pharma Tech has been able to differentiate itself from food manufacturers, who in the past were the primary manufacturers of dietary supplement products.

 

On September 12, Pharma Tech attended its first CRN director's meeting in Washington, DC.  Pharma Tech believes that it can, through its involvement with the CRN, influence and guide the quality and regulatory requirements for dietary supplements.  Additionally, Pharma Tech is a proven expert in the manufacture of powder and solid dose products.  Together, Pharma Tech believes that it can produce high quality, affordable products for the millions of consumers who use dietary supplements daily.

PHARMA TECH EXHIBITS AT CONTRACT PHARMA SHOW

 

 

In September, Pharma Tech attended and exhibited at the Contract Pharma Trade Show in New Brunswick, NJ and was one of about 70 other CMO's participating.  The Pharma Tech team benefited through meeting new potential partners as well as reconnecting with current partners.  This event also proved to be a valuable networking opportunity with other CMO's to discuss the ever changing dynamics in the industry.  Pharma Tech looks forward to building on some of these new relationships and opportunities in the coming months.

 

 

 

 

We make products that fulfill promises

 

Pharma Tech Industries, 297 Prince Avenue, Suite 11, Athens, GA 30601