PharmaceuticalOutsourcingQ42020 - 34

ROUNDTABLE

in favor of manufacturers that are geographically closer and can

Although drug product manufacturing in Europe is still well

guarantee supply in critical situations.1

established, the end of the 1990s and 2000s saw much of the

As a result, several countries are implementing new processes to

industry's API production relocated to India and China. Over last

onshore API production in an effort to secure their supply chains.

years, multiple shortages of key pharmaceuticals have already been

Namely, there is talk of new legislation in the USA which would

recorded, but the current coronavirus pandemic has highlighted

mandate the production of APIs on America's shores - a costly move

certain vulnerabilities in this model - fragmented supply chains with

for the industry. The so-called " Buy American " order exempts the

limited ability to react to changes.

import of certain drugs if they are already in abundant supply or

Many existing manufacturing facilities across Europe require

if procuring them in the U.S. would increase the cost by more than

extensive modernization to comply with increasingly stringent

25%, something that the pharma industry hasn't exactly welcomed.2

safety and quality requirements. The temptation to move

On the opposite side of the world, India relied on China for around

production - and invest outside of Europe - to low-cost countries

70% of the APIs that it uses in pharmaceutical manufacturing.

where construction and equipment is cheaper, is understandable.

In response, the Indian government set aside $1.2 billion for

However, there are benefits to retaining production in Europe.

the pharmaceutical industry and announced the creation of a
production-linked incentive scheme for the manufacturing of
critical drugs and APIs to shift the country's reliance on the supply
of APIs from China.3
As result of such an increase in the use of APIs on the horizon, we are
already witnessing greater investment in local manufacturing sites
for API production whereby manufacturers must achieve effective,
validated containment and sterile transfer, a challenge in the
modern pharmaceutical manufacturing environment. This results in
a need for manufacturers to invest in the appropriate equipment,

One reason for localization is to create more skilled jobs within each
country and reduce the trade balance deficit. This does, however,
raise some questions, for example, which pharmaceutical companies
are willing to give up low-cost supply? How will such a move affect
the cost of the finished drug product? Will the industry be able to
ensure that plant capacity is available for each new product in each
of the countries where there is high demand to ensure a good, listed
price? Ultimately, there is an argument that this model raises the
complexity of supply chains.

especially if containment and aseptic processing are required.

Although better quality control could also support the argument

During material transfer, effective engineering controls are crucial

for relocating drug production to Europe, many Chinese and Indian

as employee safety is the primary focus, however companies also

suppliers now pass FDA inspections without observations. And what

aim for minimal disruption to the manufacturing process.

about reliability of supply? There's nothing to suggest the industry
would have been more reactive to the tensions on the supply of

Jean-Fran├žois Hilaire, Executive Vice President -

pharmaceuticals due to the COVID-19 pandemic, if production

Strategy and Global Integration, Recipharm
Pharmaceutical supply chains need constant monitoring and

facilities were all based in Europe.

improvement to ensure operations are optimized, globally.

There are some clear reasons why Europe is an excellent choice for

More than ever, with the COVID-19 pandemic, and the resulting

API and drug product development and manufacturing including

pressure it has placed on certain parts of the pharmaceutical

access to highly skilled scientists, substantial funds, and tax break

supply chain, Europe's reliance on APIs and intermediates which

benefits granted by government or European institutions for

are manufactured outside of Europe is under the spotlight. Several

research. It would, therefore, be sensible for products discovered

European governments are now trying to convince companies to

and developed in Europe to remain in this market, particularly as

consider the relocation of API and pharmaceutical production in

the economic model of emerging countries is evolving, resulting in

Europe if not in their home country.

higher supply pricing.

1.	

http://www.samedanltd.com/magazine/15/issue/325/article/5315 2.	

2.	

https://www.pharmamanufacturing.com/articles/2020/bring-it-home/?utm_campaign=PHMDD_2020_Enews_Campaign&utm_medium=email&_
hsmi=95385714&_hsenc=p2ANqtz-_H01YMS3P5TZ05ktlKYk9MeTxua4XulipzNNQPvRP53ojS9daQO91ikrMgAU1e2Nd3Us4JJq-PXstKGk-EQSpkY_bw7A&utm_
content=95385714&utm_source=hs_email

3.	

https://www.thepharmaletter.com/article/indian-government-moves-on-apis-as-chinese-supplies-are-returning
Pharmaceutical Outsourcing |

34

| October/November/December 2020


http://www.samedanltd.com/magazine/15/issue/325/article/5315 https://www.pharmamanufacturing.com/articles/2020/bring-it-home/?utm_campaign=PHMDD_2020_Enews_Campaign&utm_medium=email&_ hsmi=95385714&_hsenc=p2ANqtz-_H01YMS3P5TZ05ktlKYk9MeTxua4XulipzNNQPvRP53ojS9daQO91ikrMgAU1e2Nd3Us4JJq-PXstKGk-EQSpkY_bw7A&utm_content=95385714&utm_source=hs_email https://www.thepharmaletter.com/article/indian-government-moves-on-apis-as-chinese-supplies-are-returning

PharmaceuticalOutsourcingQ42020

Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Roundtable
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4
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https://www.nxtbook.com/comparenetworks/PharmaceuticalOutsourcing/PharmaceuticalOutsourcing2021CompanyFocus
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