International Pharmaceutical
Supply Chains Include Active Pharmaceutical
Ingredient (API) Manufacturers, Pharmaceutical
Intermediate Manufacturers, and Pharmaceutical
Excipient Manufacturers All of Which Can Cause
Adulterated and Dangerous Pharmaceuticals if
Pharmaceutical Supply Chain Fraud Occurs by
International Pharmaceutical Supply Chain Fraud
Whistleblower Reward Lawyer, International Adulterated Drug
Whistleblower Lawyer, and International Pharmaceutical
Executive Whistleblower Reward Lawyer Jason S. Coomer
Pharmaceutical
suppliers of raw materials to the pharmaceutical
industry include suppliers of active
pharmaceutical ingredients (APIs),
intermediates, and excipients. It
is the United States Food and Drug Administration's
expectation that current good manufacturing
practices (CGMP) be used for the manufacturing,
processing, packing, or holding (i.e., storage) of
active pharmaceutical ingredients (APIs),
intermediates, and excipients. Further, the
FDA recommends that laboratory controls should
include the establishment of scientifically sound
and appropriate specifications, standards, sampling
plans, and test procedures to ensure that raw
materials, intermediates, APIs, and containers
conform to established standards of quality and
purity.
Traditional West European
and North American API Manufactures have been
Replaced by Indian API Manufacturers and Chine API
Manufacturers
The active pharmaceutical
ingredient (API) market is very competitive with
many producers with many API manufacturers
specializing and targeting their manufacturing based
on joint venture contracts, large pharmaceutical
company demand, governmental procurement contracts,
regional resources and availability of supplies, and
other logistical and profit driven factors. Driven
by profits and lower costs, API manufacturing has
slowly been shifting from the historical leaders in
Western countries to newer firms in India and China.
The overall API market was valued
at $101.08 billion in 2010, and is expected to grow
at a CAGR of 7.9% from 2011 to 2016. In 2005,
the total world API market was $76B and growing at
an average annual rate of 8.2%. The market share held by Indian
API manufacturers in the global API merchant market
(generic APIs and branded/innovator APIs) was 6.5%
in 2005, 12.0% in 2010, and is expected to increase
to 22.0% by 2015. India is
expected to be the fastest growing API supplier
during the next five years and will keep its
position above China.
The market share held by Chinese
companies in the global API merchant market (generic
APIs and branded/innovative APIs) has risen from
14.2% in 2005 to 19% in 2010. Although China remains the largest
API supplier on a global basis, growth rates from
2005–2010 of Chinese API suppliers were less than
those of Indian suppliers. China’s share of the
Western European generic API merchant market fell
from 39.2% in 2005 to 35% in 2010. China’s share of
the US generic API merchant market increased
slightly from 11.5% to 12.9% in 2010. While Italy still remains the
world market leader in APIs destined to sectors such
as cardiovascular or the central nervous system,
China leads in anti-infective APIs.
As a generalization, Chinese
firms have tended to focus on the earlier raw
materials stage whereas Indian firms have tended to
focus more on the final API manufacturing stage. In
many cases, a Chinese firm will make the raw
material for a pharmaceutical product and then sell
it to an Indian firm who will then convert the raw
material into an API. Then, either the same firm,
another Indian firm, a global Multinational
Corporation (MNC) or a final formulator in a
developing country will convert the API into a final
formulation product ready for the market. However,
the situation is rapidly evolving as both China and
India gain new manufacturing skills. Not
surprisingly, while many Western API firms have been
winding down and/or consolidating their
manufacturing capacity, many firms in India and
China have been increasing capacity to meet the
growing demand.
Traditional West European
and North American Excipient Manufacturers have been
Replaced by Indian Excipient Manufacturers and Chine
Exipient Manufacturers
Pharmaceutical
excipients play an important role in pharmaceutical
formulations by adding functionality or by
facilitating the processing of a drug product.
Recent trends in the pharmaceutical excipient
manufacturer industry include: geographic expansion
and select investment in emerging markets. The global market for excipients
totaled $4.9 billion in 2011. That value is
projected to reach more than $6.7 billion in 2016
after increasing at a five-year compound annual
growth rate (CAGR) of 6.5%. The global
excipients market can be broken down by material
type into three segments – organic, inorganic, and
USP (U.S. pharmaceutical) water. The
segment made up of organic excipients held a value
of nearly $4.6 billion in 2011, and is expected to
grow at a CAGR of 6.6% to reach a value of nearly
$6.3 billion in 2016. The segment made up of
inorganic excipients, worth $268 million in 2011,
should be worth $350 million in 2016, a CAGR of
5.5%. The USP water excipients segment totaled $92
million in 2011, and in 2016 that value should reach
$114 million, a CAGR of 4.4%.
Increased globalization and
strategies for securing the supply chain are
important issues for excipient producers. The
International Pharmaceutical Excipients Council (IPEC)
expanded into China in July 2008 with the formation
of IPEC–China.
Regulations for
Pharmaceutical Ingredients and Raw Materials
Regulation for pharmaceutical
ingredients and raw materials can be complicated and
can change depending on where the pharmaceutical
ingredients are coming from and where they are being
sold. As such, an international producer from
China or India that manufactures an API or excipient
that sells it to a final formulator in the United
States can be subject to the regulatory authorities
in China and the United States. The API or
excipient manufacturer should be required to produce
the product to the quality standards enforced by the
Chinese authorities as well as will be required to
meet USFDA standards as well.
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pharmaceutical supply chain and other health care
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pharmaceutical ingredients, adulterated medicine,
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