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DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 22 News #PharmaBuzz

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Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
22 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

20 All APIs, 14 USDMF, 1 CEP/COS, 1 NDC API, 6 Listed APIs

20 All APIs
14 USDMF
1 CEP/COS
1 NDC API
6 Listed APIs

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

EXCIPIENTS

15 All Excipients, 15 USDMF, 60 Listed Products

excipientPortfolio
15 All Excipients
15 USDMF
60 Listed Products

EXCIPIENTS BY INGREDIENTS

Benzalkonium chloride excipient, polyethylene glycol, Toluene Excipient, Sodium Citrate Dihydrate Excipient, Maltitol Excipient, 2-Phenoxyethanol Excipient, CALCIUM CHLORIDE DIHYDRATE Excipient, Glycerol Excipient, Polysorbate 80, Phenylethyl Alcohol Excipient, Sodium Chloride Excipient, Cetrimonium Bromide Excipient, Benzenesulfonic acid excipient, Xylitol Excipient, Polysorbate 20, Heptane, Potassium Phosphate Monobasic Excipient, Benzyl Alcohol, Maltodextrin Excipient, Choline Chloride Excipient, Creatinine excipient, Thimerosal Excipient, Propylene Glycol, Hydrochloric Acid Excipient, Benzyl Benzoate Excipient, Potassium Chloride Excipient, Sodium Hypochlorite Excipient, Cyclohexane Excipient, POTASSIUM DIHYDROGEN PHOSPHATE Excipient, L Lactic Acid, Formaldehyde Excipient, Sorbitan Trioleate, Monothioglycerol Excipient, Acetone Excipient, Sodium Hydroxide Excipient, Squalane Excipient, Diethanolamine Excipient, Sodium Saccharin Excipient, Benzethonium Chloride Exc, Calcium Saccharate, Urea, Zinc Stearate Excipient, Ethylenediamine Excipient, Benzyl Alcohol Excipient, Sodium Tartrate excipient, COD Liver Oil Excipient, Sucrose

excipientsByIngredients
Benzalkonium chloride excipient
polyethylene glycol
Toluene Excipient
Sodium Citrate Dihydrate Excipient
Maltitol Excipient
2-Phenoxyethanol Excipient
CALCIUM CHLORIDE DIHYDRATE Excipient
Glycerol Excipient
Polysorbate 80
Phenylethyl Alcohol Excipient
Sodium Chloride Excipient
Cetrimonium Bromide Excipient
Benzenesulfonic acid excipient
Xylitol Excipient
Polysorbate 20
Heptane
Potassium Phosphate Monobasic Excipient
Benzyl Alcohol
Maltodextrin Excipient
Choline Chloride Excipient
Creatinine excipient
Thimerosal Excipient
Propylene Glycol
Hydrochloric Acid Excipient
Benzyl Benzoate Excipient
Potassium Chloride Excipient
Sodium Hypochlorite Excipient
Cyclohexane Excipient
POTASSIUM DIHYDROGEN PHOSPHATE Excipient
L Lactic Acid
Formaldehyde Excipient
Sorbitan Trioleate
Monothioglycerol Excipient
Acetone Excipient
Sodium Hydroxide Excipient
Squalane Excipient
Diethanolamine Excipient
Sodium Saccharin Excipient
Benzethonium Chloride Exc
Calcium Saccharate
Urea
Zinc Stearate Excipient
Ethylenediamine Excipient
Benzyl Alcohol Excipient
Sodium Tartrate excipient
COD Liver Oil Excipient
Sucrose

EXCIPIENTS BY APPLICATIONS

Topical, Parenteral, Controlled & Modified Release, Solubilizers, Taste Masking, Fillers, Diluents & Binders, Coating Systems & Additives, Film Formers & Plasticizers, Lubricants & Glidants, Thickeners and Stabilizers

excipientsByApplications
Topical
Parenteral
Controlled & Modified Release
Solubilizers
Taste Masking
Fillers, Diluents & Binders
Coating Systems & Additives
Film Formers & Plasticizers
Lubricants & Glidants
Thickeners and Stabilizers

INSPECTIONS & REGISTRATIONS

17 FDA

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17 FDA

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About

Actylis is a leading manufacturer and supplier of critical raw materials and performance ingredients serving the Life Sciences, Specialty Chemicals, and Agriscience industries. Actylis was created in September 2022 from the merger of eight experienced specialty manufacturing companies and three sourcing firms, integrated into a single entity. The companies forming Actylis include Aceto, A&C, A&C Bio Buffer, Cascade Chemistry, ...

CPhI North America CPhI North America

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20-22 May, 2025

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22-24 April, 2025

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22-25 April, 2025

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CONTACT DETAILS

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U.S.A

Address

4 Tri Harbor Court Port Washington, NY 11050

Telephone

+1 5166276000

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Website

https://actylis.com/

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INTERVIEW #SpeakPharma

[Sponsored by another company]

“Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets

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VLOG #PharmaReel

[Sponsored by another company]

Leading Global Biotechnology and Biomaterial Company

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

How Trump’s tariffs on imported drugs can hurt supply chains, consumers and industry

Ever since Donald Trump has moved into the White House for a second term, there has been turmoil across the world. One of the issues that has been of concern is ‘tariffs’. Trump is keen to reduce United States’ trade deficit through import tariffs.Since the mid-1990s, the US has been importing drugs from across the world largely tariff-free, and its drug imports have risen consistently. In 2024, the US imported US$ 213 billion worth of medicines, which was more than two and a half times the total of its drug imports ten years back.Until recently, it seemed like the administration would spare the pharmaceutical sector. But at a fundraiser dinner held for the Republican Party last week, Trump said: “We're going to be announcing very shortly a major tariff on pharmaceuticals”. The pharma tariffs, he said, would be “at a level that you haven’t really seen before”.The US is the largest consumer of pharmaceuticals globally, accounting for 45 percent of global sales. Given the nature of the global pharma industry, ‘major tariffs’ would have far-reaching impact. PharmaCompass studies the likely impact of tariffs on drug imports into the US, and whether they would serve the purpose they intend to.Cost of import tariffs, setting up domestic capacities will be borne by US consumersThe Trump administration has two key objectives behind implementing drug import tariffs. One, it wants to secure US drug supply chains by onshoring drug production. Two, it wants to create more manufacturing jobs in the US. Will tariffs be successful in achieving these objectives?Importers generally pay the tax and pass it on to the consumer. Bernstein analyst Courtney Breen estimates that in the worst-case scenario, tariffs could result in an extra US$ 53 billion in costs paid for pharmaceutical imports. According to economist Ernie Tedeschi, “costs for prescription drugs would rise by an average of around US$ 600 per year per household” in the US. Not all of that would be ‘out-of-pocket’, and families may “end up paying higher insurance premiums [and] higher co-pays”.Many drugmakers may want to avoid that cost, and shift manufacturing to the US. Though American drugmakers Eli Lilly and Johnson & Johnson have announced mega investments in the US, it’s difficult to say if other drugmakers will find it viable to set up capacities. Having said that, just this week Novartis announced a US$ 23 billion investment in the US.Overall, resources are expensive in the US. Due to heavy reliance on imports, the country does not have industrial plants needed for large-scale production. Factors like labor regulations, high cost of living, mandatory benefits etc, have made the workforce quite expensive. It’s puzzling how any drugmaker will overcome these challenges and create manufacturing jobs. Even if they do, the high costs of manufacturing will translate into costlier drugs.According to a recent report undertaken by RAND, prescription drug prices in the US are on an average 2.78 times those seen in 33 other nations. With tariffs, that gap will widen further.Drug supply chains are complex; moving capacities to US costly, time-consumingAccording to the US Food and Drug Administration (FDA), as of August 2019, only 28 percent of the facilities producing APIs for the US market were located domestically. The remaining 72 percent were overseas, with nearly half of its generics coming from India.The US is also highly dependent on drug imports for critical therapies. In 2024, the European Union supplied US$ 127 billion worth of high-value branded medicines to the US.The pharmaceutical supply chain is complex. There are a series of chemical steps involved in making any drug, with each step often being performed in different locations.The supply chain is determined by a variety of factors, such as availability of cheap labour, tax rates, supply of raw materials etc. For instance, Ireland has a very low corporate tax rate. Therefore, it has emerged as a hub for the production of APIs used in blockbuster medicines, such as Lilly’s Zepbound and Merck’s Keytruda.Moving production to the US will take five to seven years per plant. Each plant will cost US$ 2 billion or more. And it will have to go through several checks to meet America’s high regulatory standards. It is a long, arduous and unnecessary exercise, when capacities, expertise and cheaper labor is already existing in other countries.Europe also plans to onshore, leading to turbulent shift in trade dynamicsLike the US, Europe too is heavily reliant on China and India, and is working towards reducing its dependence. Over the years, Europe has moved significant resources into the US, especially in R&D. American drugmakers like Pfizer and Johnson & Johnson, on the other hand, manufacture many of their drugs in Europe and export them back to the US. Tariffs, therefore, will impact European exports in a big way. Drugmakers confronted European Commission President Ursula von der Leyen soon after Trump spoke about the pharma tariffs. These drugmakers, led by Novo Nordisk’s CEO Lars Fruergaard Jørgensen, asked for a “rapid, radical policy change” so that R&D and manufacturing doesn’t get directed towards the US.According to these drugmakers, up to 85 per cent of capital investments (about €50.6 billion, or US$ 56 billion) and up to 50 per cent of R&D expenditures (about €52.6 billion or US$ 58 billion) are potentially at risk. These figures are taken from a total of €164.8 billion (US$ 182 billion) worth of pharmaceutical investment planned in the EU during 2025 to 2029.Tariffs will test low margins of generics, may put a pause on dealmakingTariffs will have a different impact on generics. According to a Brookings report, while tariffs will “provide a strong incentive for increasing US manufacturing of brand-name drugs”, it will not be incentive enough for older, off-patent generic drugs, which “represent over 90 percent of the volume but only a small share of spending”.It will be difficult for generic drugmakers to onshore due to high capital expenditures and low and uncertain returns on investment. In fact, tariff pressure will test the wafer-thin margins of generic drugmakers in both the US and overseas. This could lead to product discontinuations or drastic cost cutting, which in turn could erode product quality.In the end, as Arthur Wong, senior director of corporate ratings, healthcare, at S&P Global Ratings, puts it, all this chaos is going to “put a pause [on] or distract” from another key pharma function: dealmaking. The time for executing M&As was now. But we can’t expect dealmaking to return until the second half of 2025.