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.
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
MARKET OPPORTUNITY - NUTRITIONALS
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.
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.
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%.
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.
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.
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
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.