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    Company profile for Wavelength Pharmaceuticals

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    Pierre Luzeau on Seqens U.S. R&D Lab Investment

    02 Jun 2023

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    SK Capital Partners to acquire SEQENS and merge Wavelength Pharma

    26 Aug 2021

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    Wavelength Pharmaceuticals signs collaboration agreement with Tikun olam-Cannbit

    16 Aug 2021

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    We are on the same wavelength. A partner in tune with the results required to better support your needs. Find out why pharmaceutical industry leaders partner with Wavelength Pharmaceuticals to acquire best-in-class solutions. Wavelength, a standalone API company, offers differentiated solutions that support your market leadership position. We provide a strategic alliance that is “customized” to include the products and service you require to go to market, such as Active Pharmaceutical Ingredients (APIs), Finished Dosage Forms (FDFs), Dossiers, and co-development partnerships.

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    Wavelength PharmaceuticalsIsrael Flag
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    Israel
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    Ofer Park, Brosh building, 4th floor 94 Shlomo Shmeltzer Road, POB 3158, Petah...
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    generics@seqens.com
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    INTERVIEW #SpeakPharma

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    “We’ve quadrupled our production and added new customers during the pandemic”

    mic“We’ve quadrupled our production and added new customers during the pandemic”

    This week, Ilan Avni, Vice President, Business Development, Wavelength Pharmaceuticals is back on SpeakPharma. He talks about Wavelength’s imminent merger with SEQENS (slated to close later this year), the company’s performance during the pandemic and its various interesting technological capabilities, such as those in enzymatic chemistry, spray drying and particle engineering solutions. In particular, Avni talks about how the merger with SEQENS will make Wavelength a global leader in the API and CDMO space with 22 production sites and 10 R&D centers across the world. — A year back, we had discussed how Wavelength’s investments in its supply chain has helped the company during the pandemic. Where do things stand today? How has the market changed? Reflecting on the past year and the ongoing Covid-19 crisis, I can say with confidence that our many years of investment in supply chain assurance has paid off. Not only have we been able to reliably supply critical drugs to our customers during the global crisis, we were also able to quadruple our production and supply to many additional new customers and territories, where other players did not have the capability to deliver. Times are changing — more and more pharmaceutical manufacturers and governments are coming to the conclusion that reliable supply is a critical investment for long-term sustainable growth. — How is Wavelength’s merger with SEQENS (slated to close later this year) likely to benefit the company? Do you expect Wavelength’s global standing and market share in the API CDMO space to improve considerably? We are extremely excited about the upcoming merger with SEQENS. We share the same values, focus on quality, regulatory compliance, and exceptional customer service. The merger will create a global leader in the API and CDMO space with 22 production sites and 10 R&D centers across the world, and a backward-integrated leader offering a broader portfolio of generic APIs and intermediates as well as custom development and manufacturing services across a wide range of added complementary pharmaceutical technologies.    — Wavelength has some interesting technologies. What capabilities have you developed in enzymatic chemistry? And what is Wavelength’s strength in this field? Enzymatic chemistry is an incredibly powerful tool for organic synthesis. It increases conversion efficiency for significantly higher yields with fewer by-products, equating to faster and more cost-effective production. This is largely due to its superior enantio-, regio-, and stereoselectivity under milder conditions, compared to using conventional metal catalysts. We have recently completed validation of a new commercial scale enzymatic process for a leading high-volume type 2 diabetes product with results by far superior to any other process in the market. Our customers are getting ready for commercial launch, and we are confident our product is going to provide them with a game changing advantage in this highly competitive market.   We already have several additional products in our pipeline developed using enzymatic chemistry and I believe that with SEQENS’ expertise in developing new tailor-made enzymes and with Wavelength’s expertise in scaling up such processes, we are going to see many more of these products in the market in the very near future. — Tell us about Wavelength’s strength in spray drying. How have customers benefitted from your capabilities? Low aqueous solubility of APIs often translates into poor bioavailability that can be a cause of failure during drug development. As such, improved aqueous solubility is a primary objective of formulation development, especially for oral, inhaled, and topical drugs. The number of poorly soluble small molecule drugs has significantly increased over the years and the demand for spray drying capacity is on the rise. Production slots are booked well in advance, creating bottlenecks that threaten to prolong time-to-market. Wavelength has more than 30 years of proven track record in spray drying and we continue to invest in particle engineering technologies, including current and next-generation spray drying technologies to address solubility and bioavailability challenges for a broad range of therapeutics. We believe this is one of the advanced skills an experienced API CDMO should be able to offer to its customers, especially those looking to develop BCS Class 2 (low solubility and high permeability) and BCS Class 4 (low solubility and low permeability) drugs. — What additional particle engineering solutions have you developed and how is Wavelength using these technologies to solve drug design challenges? We have in-house expertise in various micronization techniques, both for high volume APIs as well as corticosteroids and other highly potent APIs up to OEB5 (OEL<1 μg/m3). Our unique micronization equipment can reduce particle size from 5mm to <5μm in a single pass using ultra-low energy technology with minimum mechanical or heat impact. Therefore, there is no impact on crystalline properties or increase in amorphous content, which is a huge advantage.  Wavelength has been supplying various inhalation grade APIs for dry powder inhalers and metered dose nasals for more than 20 years now and many of our customers have selected Wavelength for particle design expertise, although they have the same API produced in-house.   — Are there any new technologies you are looking to implement in the near future? Our CDMO business is expanding very rapidly. We continue to focus on complex chemistry and are moving into GMP production of oligonucleotides. We see more and more therapeutic oligonucleotides reaching the market, offering effective treatment to many unmet needs.  These are quite large and extremely complex molecules, though still considered “small molecules” from a regulatory perspective. Processes include multiple synthesis steps, protection, cleavage and de-protection, purification, ultrafiltration and lyophilization, which are very much aligned with our manufacturing track record and also a perfect match with our complex analytics expertise. We already have six novel oligonucleotides being tech transferred to commercial scale GMP production, so we are extremely excited about this new field and are looking forward to further expand production capacity to support our customers’ demand. .  

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    https://www.pharmacompass.com/speak-pharma/we-ve-quadrupled-our-production-and-added-new-customers-during-the-pandemic-speakpharma-with-wavelength-pharmaceuticals

    #SpeakPharma With Wavelength Pharmaceuticals
    26 Oct 2021
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    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    PharmaCompass is introducing a new regulatory update that tracks developments in Certificates of Suitability to the Monographs of the European Pharmacopoeia, referred to as CEPs. These certificates are a critical regulatory instrument in the global pharmaceutical supply chain.Also known as a Certification of Suitability (COS), CEPs are issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM), with or without inspection of the manufacturing site. A CEP must be renewed every five years from its original issue date to remain valid, regardless of any revisions made during the interim period. However, a CEP does not replace Good Manufacturing Practice certification.CEPs are recognized as a trusted reference for API quality, thereby simplifying global registration strategies. Apart from Europe, the CEP system is widely used by many regulatory authorities, including those in Canada, Australia, Brazil, Singapore and South Africa. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)CEP 2.0 enhances regulatory clarity, brings efficiency, global interoperability There are several types of CEPs, depending on the nature of the substance and evaluation. The most common type is the Chemical CEP, which confirms that a chemically synthesized API meets standards for purity and impurity control. Then there are Herbal CEPs for herbal substances and preparations.Another key category is the TSE CEP, which addresses risks associated with transmissible spongiform encephalopathies in animal-derived materials. In addition, there are Combined CEPs that may cover multiple aspects, such as chemical quality, TSE risk, and sterility. However, biological products such as vaccines and blood products fall outside the scope of the CEP framework.In 2023, the CEP system underwent a major transformation with the introduction of CEP 2.0, which marks a shift from a largely document-based system to a more structured, transparent, and digitally aligned model. This makes it easier for companies to manage compliance while improving trust among global regulators.While increasing data and compliance requirements for API manufacturers, CEP 2.0 enables better regulatory clarity, streamlined dossier integration, and stronger global acceptance. Overall, CEP 2.0 is designed to enhance regulatory clarity while making the system more efficient and globally interoperable. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Indian firms issued maximum CEPs; Sun Pharma and its subsidiaries, Jubilant Biosys top listIndia topped the charts for CEPs issued, both in terms of new CEPs and revisions in the first quarter (Q1) of 2026. Indian companies were issued 81 new CEPs in Q1 2026 (as against 40 in Q1 2025) and 203 revisions (as against 129 in Q1 2025). In comparison, Chinese companies were issued 42 new CEPs in Q1 2026 (against 25 in Q1 2025) and 53 revisions (against 67 in Q1 2025). Italy came a distant third, followed by Germany and Spain.India’s Sun Pharmaceuticals and its subsidiaries topped the list of companies with the maximum number of CEPs issued— while no new CEP was issued, 27 CEPs were revised in Q1 2026. At second place was Jubilant Biosys — 21 CEPs were revised in Q1 2026.In terms of products, the maximum CEPs were issued for amlodipine besylate (a calcium channel blocker used for treating hypertension), followed by sitagliptin phosphate (a type 2 diabetes medicine) and pregabalin (a drug used to treat neuropathic pain, fibromyalgia, seizures, and generalized anxiety disorder). Both amlodipine besylate and sitagliptin phosphate had not been issued new CEPs or revisions in Q1 2025. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)EDQM introduces new guidelines to accelerate CEP assessments The EDQM charges fees for various services related to CEPs that depend on the type of request or regulatory activity involved. In general, fees apply to handling CEP applications, revisions or renewals and for offering technical advice (where applicants seek scientific or regulatory guidance).In March 2026, the EDQM introduced two new guidelines aimed at accelerating CEP assessments. The first is a reliance-based assessment pathway, which allows regulators to leverage prior approvals from trusted authorities, such as those in the EU, UK, Australia, Canada, and the WHO pre-qualification program. The second is a fast-track assessment route designed to expedite reviews in situations such as medicine shortages and to support initiatives like the EU Critical Medicines Act.Timelines have been significantly compressed under these new pathways. Initial evaluations are completed within 46 working days, compared to up to 115 days under the standard procedure. Applicants are given 30 calendar days to respond to queries, after which regulators complete the final assessment within 23 working days.Another important regulatory update relates to electronic submissions. From April 1, 2026, the EDQM will reject non-compliant CEP applications at the point of submission. All applications must include a validated electronic Common Technical Document (eCTD) dossier along with a proper validation report, submitted in line with the updated Common European Submission Portal (CESP) guidelines. Taken together, these developments signal a more rigorous yet efficient CEP ecosystem. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Our viewThe shift to CEP 2.0 signals a move toward greater transparency, digitalization, and global regulatory alignment. Though enhanced disclosure and stricter e-submission requirements may increase the compliance burden, especially for smaller manufacturers, the long-term gains are expected to be significant. Going forward, companies that invest in data quality and regulatory readiness stand to gain from these changes.
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    #PharmaFlow by PHARMACOMPASS
    09 Apr 2026
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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
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    Pierre Luzeau on Seqens U.S. R&D Lab Investment
    Pierre Luzeau on Seqens U.S. R&D Lab Investment

    02 Jun 2023

    // CONTRACT PHARMA

    https://www.contractpharma.com/contents/view_online-exclusives/2023-02-06/ceo-spotlight-pierre-luzeau-on-seqens-us-rd-lab-investment/

    CONTRACT PHARMA
    02 Jun 2023
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    SK Capital Partners to acquire SEQENS and merge Wavelength Pharma
    SK Capital Partners to acquire SEQENS and merge Wavelength Pharma

    26 Aug 2021

    // PRESS RELEASE

    https://www.wavelengthpharma.com/2021/08/26/sk-capital-partners-to-acquire-seqens-and-merge-wavelength-pharmaceuticals/

    PRESS RELEASE
    26 Aug 2021
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    Wavelength Pharmaceuticals signs collaboration agreement with Tikun olam-Cannbit
    Wavelength Pharmaceuticals signs collaboration agreement with Tikun olam-Cannbit

    16 Aug 2021

    // PRESS RELEASE

    https://www.wavelengthpharma.com/2021/08/16/wavelength-pharmaceuticals-signs-collaboration-agreement-tikun-olam-cannbit-development-manufacturing-marketing-pharma-grade-cgmp-cannabis-based-active-pharmaceutical-ingredients-api/

    PRESS RELEASE
    16 Aug 2021
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    Biocatalysis: An Indispensable Tool for API Synthesis
    Biocatalysis: An Indispensable Tool for API Synthesis

    07 Jun 2021

    // PRESS RELEASE

    https://www.wavelengthpharma.com/2021/06/09/biocatalysis-an-indispensable-tool-for-api-synthesis/

    PRESS RELEASE
    07 Jun 2021
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    Israeli API maker Wavelength buys up majority stake in Indian firm making drug
    Israeli API maker Wavelength buys up majority stake in Indian firm making drug

    19 Feb 2021

    // K.Blankenship ENDPTS

    https://endpts.com/israeli-api-maker-wavelength-buys-up-majority-stake-in-indian-firm-making-drug-starting-materials-and-intermediates/

    K.Blankenship ENDPTS
    19 Feb 2021
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    Wavelength Pharmaceuticals Further Strengthens Its Global Supply Chain with Acquisition of Vanamali Organics
    Wavelength Pharmaceuticals Further Strengthens Its Global Supply Chain with Acquisition of Vanamali Organics

    18 Feb 2021

    // PRESS RELEASE

    https://www.pharmacompass.com/pdf/news/wavelength-pharmaceuticals-further-strengthens-its-global-supply-chain-with-acquisition-of-vanamali-organics-1613647287.pdf

    PRESS RELEASE
    18 Feb 2021
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