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    Viwit Pharm’s Generics Gadobutrol Receives Approval in US

    11 Jun 2026

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    Viwit Pharm’s Generics Lidocaine HCl Receives Approval in US

    19 Mar 2026

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    Viwit Pharm's Generic Prochlorperazine Edisylate Receives Approval In US

    28 Sep 2021

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    Viwit Pharmaceuticals is a global provider of APIs, specialty generics, borane compounds, and CDMO services.

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    Viwit Pharmaceuticals is a pharmaceutical company specializing in research, development, and manufacturing of APIs, pharmaceutical intermediates, and specialty chemicals. It offers a diverse portfolio of APIs across multiple therapeutic segments and provides custom synthesis and contract manufacturing services. With a focus on quality, regulatory compliance, and process innovation, Viwit Pharmaceuticals serves pharmaceutical companies worldwide through its advanced manufacturing and R&D capabilities. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    Prostaglandin market to cross US$ 1.27 bn by 2035; Liquidia’s Yutrepia okayed for pulmonary hypertension

    Prostaglandin market to cross US$ 1.27 bn by 2035; Liquidia’s Yutrepia okayed for pulmonary hypertension

    Prostaglandins are natural fatty acid compounds produced by the human body. They are made from a type of fat known as arachidonic acid and act like messengers, controlling many functions such as inflammation, blood flow, muscle contraction, and fluid drainage in the eye. Prostaglandin APIs are synthetic (lab-made) versions of natural prostaglandins that are used to create medicines. Prostaglandin-based medicines are used in obstetrics and gynecology, gastroenterology, urology, and cosmetics, and their use is also being explored in certain cardiovascular and respiratory conditions. One of the largest and most important uses of prostaglandin APIs is in ophthalmology (eye care), where they are used as first-line therapy for open-angle glaucoma (a chronic, progressive eye disease) and ocular hypertension (a condition where pressure inside the eye is consistently higher than normal). In ophthalmic applications, these drugs usually serve as prodrugs – inactive in the formulation but converted into their active form after entering the eye.According to estimates, the global prostaglandin market is valued at US$ 0.63 billion in 2025 and is poised to grow from US$ 0.68 billion in 2026 to US$ 1.27 billion by 2035, growing at a CAGR of 7.1 percent between 2026 and 2035.Prostaglandin API manufacturing is a highly specialised field, with only a few experienced manufacturers. Companies such as EUROAPI, Cayman Pharma, Chirogate International, Kyowa Pharma Chemical, Everlight Chemical, and Yonsung Fine Chemicals are key players with strong capabilities in complex chemistry.FDA allows Glaukos’ iDose TR to be re-administered for treating eye diseases; approves Liquidia’s Yutrepia The prostaglandin market continues to see steady regulatory activity and innovations. In ophthalmology, Glaukos Corporation’s iDose TR received a labelling supplement from the US Food and Drug Administration (FDA) that allows for re-administration of the medication indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The intracameral implant was originally approved in December 2023 for single use. This update was supported by long-term safety data demonstrating good tolerability in patients with OAG and OHT. Similarly, Santen Pharmaceutical secured manufacturing and marketing approval in Japan for Setaneo (sepetaprost) ophthalmic solution 0.002% in August 2025 for the treatment of glaucoma and OHT. In April 2025, Santen also received approval in China for Tapcom (tafluprost + timolol maleate), a preservative-free fixed-dose combination therapy that lowers intraocular pressure (IOP) in patients with OAG and OHT.Beyond ophthalmology, prostaglandin APIs are also driving advancements in respiratory care. Liquidia Corporation received FDA approval in May 2025 for Yutrepia (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). While PAH is a serious and progressive disease where blood pressure in the lung arteries rises, causing them to narrow and harden, PH-ILD is a serious complication in which high blood pressure develops in the lung arteries due to lung scarring. Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary technology.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Nicox’s drug scores phase 3 win in glaucoma, OHT; United seeks expanded approval for Tyvaso to treat pulmonary fibrosisInnovation in prostaglandins is increasingly focused on enhanced efficacy and sustained drug delivery. French ophthalmology company Nicox has reported positive phase 3 results for its ophthalmic solution NCX 470, demonstrating consistent lowering of intraocular pressure in OAG and OHT. Nicox is likely to submit a new drug application for NCX 470 sometime soon, with a potential approval and launch expected in 2027.Meanwhile, US-based SpyGlass Pharma is advancing sustained-release innovation through intraocular lens (IOL)-based and ring-based drug delivery systems. Its Bimatoprost Drug Pad–Intraocular Lens (BIM-IOL) system (currently in phase 3 trials) integrates drug delivery with cataract surgery to enable sustained therapy for up to three years. The company is also developing a preclinical Bimatoprost Drug Ring System (BIM-DRS) designed for similarly extended drug release. In respiratory indications, Insmedis progressing treprostinil palmitil inhalation powder through phase 3 trials for PH-ILD, as well as for idiopathic pulmonary fibrosis and PAH.Additionally, United Therapeutics is expanding the clinical scope of Tyvaso DPI (treprostinil). Following its global approval in 2022 for PAH, the therapy is now under regulatory review in the US and Canada for progressive pulmonary fibrosis and idiopathic pulmonary fibrosis.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Glaukos sets up new R&D facility in Alabama, Inke acquires Pharmanoid to strengthen presence in prostaglandins Several players are expanding capacities due to rising demand across ophthalmology. Glaukos Corporation is setting up a new research, development, and manufacturing facility in Huntsville, Alabama. The planned 200,000 square-foot site, to be built on a 25-acre campus in Cummings Research Park, envisages an investment of over US$ 80 million. Expected to be completed by 2030, the facility is designed to augment the company’s existing infrastructure and support long-term growth, particularly in ophthalmic therapies including sustained-release drug delivery systems.EUROAPIis undertaking a significant capacity expansion at its Budapest site. The company has committed €50 million (US$ 54.8 million) to install a new state-of-the-art production plant focused on prostaglandins. The project aims to debottleneck existing operations and introduce new multi-purpose manufacturing equipment, ultimately more than doubling the site’s prostaglandin production capacity by 2027. The expansion will also strengthen EUROAPI’s highly potent API (HPAPI) capabilities.Alongside capacity additions by established players, the market is also witnessing consolidation and capability expansion through acquisitions. For instance, Essential Pharma acquired Ventavis (iloprost trometamol) from Bayer AG, including rights to the accompanying Breelib nebuliser delivery technology. Ventavis, a prostacyclin analogue, is a well-established treatment for adult patients with primary pulmonary hypertension.Inke strengthened its presence in ophthalmology-focused high-potency APIs (HPAPIs), including prostaglandins, through the acquisition of Pharmanoid in December 2025. Backed by regulatory approvals across 25+ countries, Pharmanoid enhances Inke’s capabilities in complex API production and supports its ambition to build a leading European platform for advanced API development and manufacturing. The Barcelona facility is capable of producing and handling APIs across all potency levels while adhering to SafeBridge Scale OEB4 (Occupational Exposure Band 4) containment protocols, a classification for high-potency substances requiring strict controls to limit occupational exposure.With more than two decades of experience, Inke is recognized for innovating and manufacturing high-quality APIs, delivering expertise, safety, and excellence across inhalation, CNS, and ophthalmic therapies, while supporting pharmaceutical companies worldwide. The ophthalmic API commercial portfolio includes bimatoprost, latanoprost, tafluprost, and travoprost, while the next-generation prostaglandin analog pipeline includes bimatoprost grenod and latanoprostene bunod.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Our viewInnovation is guiding the prostaglandins market towards long-acting, sustained-release formulations and novel delivery systems. These innovations are driving steady growth in prostaglandins, while capacity expansions are strengthening capabilities in complex and highly potent APIs. Overall, this remains a niche but important market to watch. 
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    14 May 2026
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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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    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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    Viwit Pharm’s Generics Gadobutrol Receives Approval in US
    Viwit Pharm’s Generics Gadobutrol Receives Approval in US

    11 Jun 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219287

    FDA
    11 Jun 2026
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    Viwit Pharm’s Generics Lidocaine HCl Receives Approval in US
    Viwit Pharm’s Generics Lidocaine HCl Receives Approval in US

    19 Mar 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220071

    FDA
    19 Mar 2026
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    Viwit Pharm's Generic Prochlorperazine Edisylate Receives Approval In US
    Viwit Pharm's Generic Prochlorperazine Edisylate Receives Approval In US

    28 Sep 2021

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213626

    FDA
    28 Sep 2021
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