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    DKSH Receives Global ISO Certifications for its Supply Chain

    18 Feb 2025

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    DKSH Annual Report 2024

    14 Feb 2025

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    Southern RNA: Revolutionizing Biotech With Advanced RNA Products

    11 Dec 2024

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    About

    DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering growth for businesses in Asia and beyond for over 155 years. DKSH operates in 36 markets, is listed on the SIX Swiss Exchange, employs 33,100 specialists, and generated net sales of CHF 11.1 billion in 2021. It is the leading global distributor of innovative pharma ingredients for pharmaceutical synthesis and formulation. It offers a range of products, ranging from animal care products to packaging materials, intermediates to nutraceuticals, and APIs to excipients.

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    DKSHSwitzerland Flag
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    Switzerland
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    Wiesenstrasse 8, P.O. Box 888 Zurich, Zurich 8034, CH
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    +49 4037473411
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    himali.pawaskar@dksh.com
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    Product List 2024

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    Performance Materials Brochure 2024

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    DATA COMPILATION #PharmaFlow

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    FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

    FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

    Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim).  Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for biosimilars has propelled growth in contract manufacturing. Some of the leading contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over the recent years, regulatory agencies like the FDA and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015,  FDA has approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and Canadian markets, Amgen and Sandoz are tied in the first place with 13 approved biosimilars each. Samsung Biologics has nine approved biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11 drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 —  down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable biosimilars this year. Interchangeable biosimilars meet additional requirements and may be substituted for its reference product by a pharmacist without consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer drug denosumab (Prolia and Xgeva) in Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars for eye drug aflibercept (Eylea) in Opuviz and Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5 trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two percent of prescriptions, they account for 46 percent of all pharmaceutical spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4 billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US savings are projected to reach US$ 181 billion through 2027. Between 2026 and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop 19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April and May of this year, respectively.Opdivo (nivolumab), belonging to the same class of drugs, competes with Keytruda and is also set to lose patent protection in 2028. It hauled in US$ 10 billion in total global sales in 2023 for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between 2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith over 2 billion people worldwide unable to access life-saving medicines, biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira.  In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.
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    NEWS #PharmaBuzz

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    DKSH Receives Global ISO Certifications for its Supply Chain
    DKSH Receives Global ISO Certifications for its Supply Chain

    18 Feb 2025

    // PRESS RELEASE

    https://www.dksh.com/in-en/home/media/news?id=en-2e7209f9-0524-49bc-838b-1c66e51c1d67:1

    PRESS RELEASE
    18 Feb 2025
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    DKSH Annual Report 2024
    DKSH Annual Report 2024

    14 Feb 2025

    // PRESS RELEASE

    https://www.dksh.com/global-en/home/media/financial-reports

    PRESS RELEASE
    14 Feb 2025
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    Southern RNA: Revolutionizing Biotech With Advanced RNA Products
    Southern RNA: Revolutionizing Biotech With Advanced RNA Products

    11 Dec 2024

    // PRESS RELEASE

    https://www.dkshdiscover.com/en/articles/southern-rna-revolutionizing-biotechnology-with-cutting-edge-rna-products/southern-rna

    PRESS RELEASE
    11 Dec 2024
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    Future of Industrial Proteins: Tubermine® FV & GP from Potatoes
    Future of Industrial Proteins: Tubermine® FV & GP from Potatoes

    10 Dec 2024

    // PRESS RELEASE

    https://www.dkshdiscover.com/en/articles/the-future-of-industrial-proteins-tubermine-fv-and-gp-from-potatoes/industrial-proteins

    PRESS RELEASE
    10 Dec 2024
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    Transforming Wellness with DKSH's Nutraceutical Innovations
    Transforming Wellness with DKSH's Nutraceutical Innovations

    21 Nov 2024

    // PRESS RELEASE

    https://www.dkshdiscover.com/en/articles/transforming-wellness-with-dksh-s-nutraceutical-innovations/nutraceutical

    PRESS RELEASE
    21 Nov 2024
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    DKSH Sets Strategic Priorities For Growth, Margin Expansion,M&A
    DKSH Sets Strategic Priorities For Growth, Margin Expansion,M&A

    18 Nov 2024

    // PRESS RELEASE

    https://www.dksh.com/in-en/home/media/news?id=en-32ff5513-3d7c-43b5-bcac-b651a811f493:1

    PRESS RELEASE
    18 Nov 2024
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    KEY PRODUCTS

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    Excipients

    Discover the DDS // excipients from this company

    Listed Products

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    01

    Brand Name : Blanose CMC 7LP EP

    Switzerland
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    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Cream / Lotion / Ointment, Syrup

    Grade : Oral, Topical

    DKSH

    Application : Rheology Modifiers, Thickeners and Stabilizers

    Excipient Details : Blanose CMC 7LP EP is used as thickening agent and a viscosity modifier in oral liquids and topical dosage forms.

    Pharmacopoeia Ref : EP

    Technical Specs : N/A

    Ingredient(s) : Sodium Carboxymethyl Cellulose Excipient

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    CPhI WW Frankfurt
    Booth #8.0P66

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    02

    Brand Name : BLANOSE CMC 7MF

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Suspension

    Grade : Oral

    DKSH

    Application : Rheology Modifiers, Thickeners and Stabilizers

    Excipient Details : Blanose CMC 7MF is used as a thickener and viscosity modifier in liquid formulations such as suspensions.

    Pharmacopoeia Ref : EP, USP/NF

    Technical Specs : N/A

    Ingredient(s) : Sodium Carboxymethyl Cellulose Excipient

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    BLANOSE CMC 7MF
    CPhI WW Frankfurt
    Booth #8.0P66

    Excipients Web Link

    Market Place

    03

    Brand Name : BORIC ACID

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Cream / Lotion / Ointment

    Grade : Topical

    DKSH

    Application : Topical

    Excipient Details : Boric acid is used as an antimicrobial preservative in topical formulations such as creams and ointments.

    Pharmacopoeia Ref : EP

    Technical Specs : 99.9 % Boric Acid (H3BO3)

    Ingredient(s) : Boric Acid Excipient

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    BORIC ACID
    CPhI WW Frankfurt
    Booth #8.0P66

    Excipients Web Link

    Market Place

    04

    Brand Name : CALCITEC PURO PH V/40S HT

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Capsule, Granule / Pellet, Tablet

    Grade : Oral

    DKSH

    Application : Fillers, Diluents & Binders

    Excipient Details : Calcitec Puro PHV/40S HT is used as filler and binder in oral solid dosage forms including tablets, capsules, granules, and pellets.

    Pharmacopoeia Ref : N/A

    Technical Specs : N/A

    Ingredient(s) : Calcium Carbonate Excipient

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    CALCITEC PURO PH V/40S HT
    CPhI WW Frankfurt
    Booth #8.0P66

    Excipients Web Link

    Market Place

    05

    Brand Name : CAPMUL 808G

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Cream / Lotion / Ointment, Solution

    Grade : Oral, Topical

    DKSH

    Application : Surfactant & Foaming Agents, Topical

    Excipient Details : Capmul 808G is used in topical formulations and as a surfactant in creams, lotions, and solutions.

    Pharmacopoeia Ref : EP, USP/NF

    Technical Specs : N/A

    Ingredient(s) : Glyceryl Monocaprylate Excipient

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    CAPMUL 808G
    CPhI WW Frankfurt
    Booth #8.0P66

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    06

    Brand Name : CAPTEX 300

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Capsule, Emulsion, Solution, Suspension, Tablet

    Grade : Parenteral, Oral, Topical

    DKSH

    Application : Fillers, Diluents & Binders, Lubricants & Glidants, Parenteral, Topical

    Excipient Details : Captex 300 is used in parenteral solutions and suspensions, topical emulsions, and as filler and lubricant in capsules and tablets.

    Pharmacopoeia Ref : EP, USP/NF, JP, US FDA

    Technical Specs : LOW C6

    Ingredient(s) : Glyceryl Tricaprylate Excipient

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    CAPTEX 300
    CPhI WW Frankfurt
    Booth #8.0P66

    Excipients Web Link

    Market Place

    07

    Brand Name : CAPTEX 355

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Capsule, Emulsion, Tablet

    Grade : Oral, Topical

    DKSH

    Application : Fillers, Diluents & Binders, Lubricants & Glidants, Topical

    Excipient Details : Captex 355 is used in topical emulsions and as a lubricant and filler in capsules and tablets.

    Pharmacopoeia Ref : EP, USP/NF, JP, US FDA

    Technical Specs : N/A

    Ingredient(s) : Glyceryl Tricaprylate Excipient

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    CAPTEX 355
    CPhI WW Frankfurt
    Booth #8.0P66

    Excipients Web Link

    Market Place

    08

    Brand Name : CAPTEX 355 INJ

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Solution, Suspension

    Grade : Parenteral

    DKSH

    Application : Parenteral

    Excipient Details : Captex 355 INJ is used in parenteral solutions and suspensions.

    Pharmacopoeia Ref : EP, USP/NF, JP, US FDA

    Technical Specs : INJ Grade

    Ingredient(s) : Glyceryl Tricaprylate Excipient

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    CAPTEX 355 INJ
    CPhI WW Frankfurt
    Booth #8.0P66

    Excipients Web Link

    Market Place

    09

    Brand Name : CAPTEX 8000

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Capsule, Emulsion, Solution, Suspension, Tablet

    Grade : Parenteral, Oral, Topical

    DKSH

    Application : Fillers, Diluents & Binders, Lubricants & Glidants, Parenteral, Topical

    Excipient Details : Captex 8000 is used in parenteral solutions and suspensions, topical emulsions, and as filler and lubricant in capsules and tablets.

    Pharmacopoeia Ref : JP, US FDA

    Technical Specs : N/A

    Ingredient(s) : Glyceryl Tricaprylate Excipient

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    CAPTEX 8000
    CPhI WW Frankfurt
    Booth #8.0P66

    Excipients Web Link

    Market Place

    10

    Brand Name : CAPTEX INJ 8000

    Switzerland
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Capsule, Emulsion, Solution, Suspension, Tablet

    Grade : Parenteral, Oral, Topical

    DKSH

    Application : Fillers, Diluents & Binders, Lubricants & Glidants, Parenteral, Topical

    Excipient Details : Captex INJ 8000 is used in topical emulsions, parenteral suspensions and solutions, and as a lubricant and filler in tablets and capsules.

    Pharmacopoeia Ref : JP, US FDA

    Technical Specs : N/A

    Ingredient(s) : Glyceryl Tricaprylate Excipient

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    CAPTEX INJ 8000
    CPhI WW Frankfurt
    Booth #8.0P66

    Excipients Web Link

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    Excipients by Ingredients

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
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    CPhI WW Frankfurt
    Booth #8.0P66

    District Decision : No Action Indicated

    Inspection End Date : 2011-10-06

    DKSH

    City : Mt Arlington

    State : NJ

    Country/Area : US

    Zip : 07856-1312

    District : NWJ

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-10-06

    DKSH Company Banner

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    02

    FDA Audited

    USA
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    CPhI WW Frankfurt
    Booth #8.0P66

    District Decision : No Action Indicated

    Inspection End Date : 2011-10-06

    DKSH

    City : Mt Arlington

    State : NJ

    Country/Area : US

    Zip : 07856-1312

    District : NWJ

    Center : CFSAN

    Project Area : Colors and Cosmetics Technology

    District Decision : No Action Indicated

    Inspection End Date : 2011-10-06

    DKSH Company Banner

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    03

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #8.0P66

    District Decision : No Action Indicated

    Inspection End Date : 2011-10-06

    DKSH

    City : Mt Arlington

    State : NJ

    Country/Area : US

    Zip : 07856-1312

    District : NWJ

    Center : CFSAN

    Project Area : Foodborne Biological Hazards

    District Decision : No Action Indicated

    Inspection End Date : 2011-10-06

    DKSH Company Banner

    Product
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    Stock Recap
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