Wavelength Pharmaceuticals DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

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

02 Jun 2023

// CONTRACT PHARMA

SK Capital Partners completes acquisition of SEQENS and merges Wavelength Pharma

17 Dec 2021

// PRESS RELEASE

SK Capital Partners to acquire SEQENS and merge Wavelength Pharma

26 Aug 2021

// PRESS RELEASE

DATA COMPILATION
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DIGITAL CONTENT

2 Interview #SpeakPharma, 1 Data Compilation #PharmaFlow, 32 News #PharmaBuzz

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2 Interview #SpeakPharma
1 Data Compilation #PharmaFlow
32 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

4 All APIs, 3 USDMF, 1 VMF

4 All APIs
3 USDMF
1 VMF

INSPECTIONS & REGISTRATIONS

1 EDQM, 2 GDUFA

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2 GDUFA

About

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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16-18 July, 2025

MITEC, Kuala Lumpur, Malaysia
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14-18 July, 2025

Philadelphia, PA
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08-10 September, 2025

Parsippany NJ, Hilton

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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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+972 35773880

generics@seqens.com

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https://www.seqens.com/

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INTERVIEW #SpeakPharma

“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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DATA COMPILATION #PharmaFlow

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.