This week, SpeakPharma interviews Miquel Bachs, CEO of Inke, a company with over two decades of expertise in micronization and particle engineering, and a leader in providing high-quality, effective solutions in the global fight against chronic respiratory diseases such as COPD and asthma. In this insightful conversation, Bachs shares Inke’s strategic vision, technological innovations, and commitment to sustainability, offering a comprehensive look at how the company is shaping the future of respiratory health.
HIGHLIGHTS// Inke’s strategic vision/ technological innovations/ commitment to sustainability
Studies suggest that 13 percent of people over 40 years of age, the world over, have chronic obstructive pulmonary disease (COPD). Given the increasing prevalence of respiratory diseases, how does Inke position itself as a leader in the development and manufacturing of respiratory APIs?
Inke has established itself as a global leader in generic respiratory API development through our unique blend of technological innovation, expertise in micronization, and a comprehensive portfolio of inhalation therapies. With over 20 years of experience in micronization and particle engineering, our ability to customize APIs to meet specific client requirements has resulted in highly effective, high-quality products tailored for respiratory therapies.
The increasing prevalence of chronic respiratory diseases, such as COPD and asthma, has only underscored Inke’s pivotal role in supporting the pharmaceutical industry’s need for advanced treatments. We specialize in bronchodilators and other critical respiratory APIs that improve patient outcomes and meet the stringent regulatory requirements of global health authorities.
Our end-to-end approach, from early-stage API development to
commercial-scale production, ensures that we maintain the highest standards of
quality, safety, and efficacy.
As the market for respiratory APIs continues to evolve, Inke
remains committed to expanding its portfolio to address unmet therapeutic
needs. Beyond respiratory APIs, we are also prioritizing growth in CNS
treatments and building on our expertise in complex molecule synthesis. This
strategic focus allows us to provide an integrated solution that not only meets
current market demands but also anticipates future pharmaceutical trends.
HIGHLIGHTS// comprehensive portfolio of
inhalation therapies/ over 20 years of experience in micronization and particle
engineering/ specialize in bronchodilators and other critical respiratory APIs/
prioritizing growth in CNS treatments
In the field of micronization, what differentiates Inke’s approach from that of other manufacturers of respiratory APIs?
What sets Inke apart in micronization is our advanced particle
size reduction technology and our dedication to precision. Our facility is
equipped with various milling techniques such as Cone, Jet, and Pin mills,
allowing us to reduce particle size while stabilizing the amorphous content to
ensure consistent quality.
Our in-depth understanding of respiratory APIs, combined with our
ability to tailor solutions for each customer, results in APIs with improved
solubility, stability, and bioavailability, which are critical for the efficacy
of inhalation products. This, along with our exceptional quality standards and
a flawless audit track record, has positioned us as a key partner for major
players in the inhalation market.
HIGHLIGHTS// advanced particle size
reduction technology/ technological innovations/ tailor solutions/ improved
solubility, stability, and bioavailability
Developing complex APIs can
be challenging. How does Inke ensure a smooth and successful partnership throughout
the development and manufacturing process, including customization, ensuring
regulatory compliance and timely delivery?
At Inke, we are dedicated to fostering strong partnerships with
our clients through a collaborative approach that prioritizes open
communication and mutual understanding. Our commitment to quality and
personalized service sets us apart in the pharmaceutical landscape.
Our team takes the time to engage in comprehensive discussions to customize our solutions, ensuring alignment with client specifications across all batches and grades. This commitment to flexibility allows us to respond effectively to evolving requirements, solidifying Inke’s reputation as a reliable partner.
We understand that navigating regulatory landscapes can be
challenging. That's why our team is equipped to manage all aspects of the
regulatory process with meticulous attention to detail. From the submission of
Drug Master Files (DMFs) and Certificates of Suitability to crafting precise
responses to potential Deficiency Letters, we ensure compliance at every step.
Moreover, we offer extensive support in patent and intellectual property matters, providing technical assistance and guidance tailored to the specific requirements of each region. Our unwavering dedication to quality, coupled with our agile
response capabilities, enables us to deliver exceptional results while
maintaining transparency and trust. At Inke, we are committed to building
lasting relationships that drive success for both our clients and our
organization.
HIGHLIGHTS// ensuring alignment with
client specifications/ manage all aspects of the regulatory process/ support in
patent and intellectual property matters
Given Inke’s global presence, what are the key markets for growth and how does Inke plan to expand its market reach and strengthen its position in these regions?
Inke is strategically focused on expanding its footprint in the
European and US markets, where we continue to prioritize our efforts. The US
market remains pivotal for us, especially considering our successful FDA
inspections and ongoing regulatory compliance efforts that solidify our
reputation.
Japan is another significant market where we have established a robust presence, reflecting our commitment to high-quality manufacturing and innovation. Looking ahead, China represents a key growth opportunity for Inke. With 12 active DMFs registered, we are well-positioned to tap into this burgeoning market.
Our strategy involves leveraging our existing capabilities to
navigate regulatory landscapes and fostering strong partnerships within the
region, thereby enhancing our market reach and influence in the pharmaceutical
sector.
HIGHLIGHTS// expanding footprint in the European and US markets/ China represents a key growth opportunity for Inke
With Inke expanding into contract manufacturing organization (CMO) services, how does this new offering align with Inke’s broader strategic goals, and what advantages does it provide to pharmaceutical partners?
At Inke, the introduction of CMO services is a natural extension
of our core expertise in the development and manufacturing of high-quality
generic APIs. Our expansion into CMO is part of a strategic move to diversify
our service portfolio, allowing us to offer end-to-end solutions for our
clients.
The CMO service integrates seamlessly with our expertise in API
manufacturing, particularly in micronization, which has been a key
differentiator for Inke for over two decades. With our advanced particle
engineering capabilities, we can offer tailored solutions that meet specific
technical and regulatory requirements. Whether it is small-batch production or
scaling up to commercial quantities, we offer the flexibility to accommodate a
wide range of customer needs.
This adaptability, paired with our deep expertise in micronization, allows us to support evolving project needs, maintaining the highest standards of consistency, quality, and performance that define Inke’s footprint.
HIGHLIGHTS// CMO is part of a strategic
move to diversify our service portfolio/ deep expertise in micronization
What is Inke’s commitment to sustainability and corporate social responsibility and how is it integrating sustainable practices into its operations and product development?
At Inke, we recognize that integrating environmental, social, and
governance (ESG) principles into our operations is not just a responsibility
but a pathway to long-term success. Our ESG vision is centered around aligning
business growth with sustainable practices that positively impact our
communities and the environment.
We are dedicated to environmental responsibility, actively
implementing initiatives such as efficient wastewater treatment and water reuse
systems to minimize our ecological footprint. Our recent investments in energy
efficiency include the installation of a 135 kWp solar panel system, which
underscores our commitment to reducing emissions and resource consumption
across our manufacturing and research facilities.
Inke is also committed to fostering a diverse and inclusive
workforce. With a notable increase in our team members, particularly in
operations and quality assurance, we prioritize career development and the
well-being of our employees. By adhering to high regulatory standards, we
ensure our products meet stringent global requirements, enhancing our
transparency and compliance.
Through these initiatives, Inke aims to cultivate sustainable
practices that not only support our business objectives but also contribute
positively to the pharmaceutical industry and society at large.
HIGHLIGHTS// integrating ESG principles/ efficient wastewater treatment and water reuse systems/ installation of a 135 kWp solar panel system/ diverse and inclusive workforce
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