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    Pfanstiehl Launches Pure Glycine Injectable Grade Excipient

    25 Jan 2025

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    Pfanstiehl Launches Low-Endotoxin Glucose for Biologics

    28 Nov 2024

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    Pfanstiehl Launches Succinic Acid Excipient Grade

    11 Oct 2024

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    Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    Pfanstiehl is a leader in high-purity, low endotoxin, low metals parenteral-grade excipient manufacturing for biologic formulations. The company’s expertise includes isolation, purification, custom synthesis, and scale-up development to support injectable products. Pfanstiehl supplies injectable grade excipients from gram-scale to multi-ton quantities and is trusted by leading pharmaceutical companies worldwide for consistent purity, low endotoxin levels, and minimal trace metals in injectable formulations. 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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    VLOG #PharmaReel

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    ReelPharmaYour Biologic Therapeutic Stabilization, Protection & Delivery PartnerYour Biologic Therapeutic Stabilization, Protection & Delivery Partner

    Your Biologic Therapeutic Stabilization, Protection & Delivery Partner
    Your Biologic Therapeutic Stabilization, Protection & Delivery Partner

    reelYour Biologic Therapeutic Stabilization, Protection & Delivery Partner

    This PharmaReel highlights Pfanstiehl's portfolio, featuring highest-purity, low-endotoxin injectable-grade excipients, generic APIs and intermediates, HPAPIs, and modified carbohydrates. The company provides API custom synthesis and ADC linker manufacturing services, all backed by USFDA certification.

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    Excipient Market Overview: Evonik launches high-purity excipients; India mandates disclosures from March 2026

    Excipient Market Overview: Evonik launches high-purity excipients; India mandates disclosures from March 2026

    The global pharmaceutical excipients market continued to evolve in the third quarter (Q3) of 2025, supported by rising demand for functional excipients, growth in production of generics, and advances in drug delivery technologies. The global market for pharmaceutical excipients was estimated at US$ 9.8 billion to US$ 10.7 billion in 2024, and is projected to grow at a compound annual growth rate (CAGR) of 4.1 to 6.6 percent through 2030. At this pace, the market is expected to reach US$ 13.05 billion to US$ 14.86 billion by 2030. Europe retained the largest market share in 2024, followed by Asia-Pacific. Key drivers shaping the excipients market include the rising prevalence of chronic diseases, expansion of biologics and biosimilars, and increasing quality and regulatory expectations. Increased investments in facility expansions and ongoing reforms in clinical trial regulations are also facilitating market growth. The sector remains highly competitive and fragmented. Major excipient providers include BASF, Roquette, Gangwal Healthcare, DuPont, Evonik, Seqens, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Colorcon, Kewpie Corporation, ICE Pharma, Nanjing Well Pharmaceutical, Merck KGaA owned MilliporeSigma, Minakem, Ashland Global, Actylis and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)  Evonik in partnership with Ethris; Colorcon Ventures invests in Phytolon   The market saw strategic collaborations across the excipients and drug formulation ecosystem in Q3 2025. Evonik entered into a partnership with Ethris to strengthen its nucleic acid delivery platform. The collaboration integrates Ethris’ proprietary technology — its lipidoid nanoparticle platform, known as SNaP LNP — into Evonik’s CDMO offerings, enhancing the latter’s ability to support RNA-based therapeutics from concept to clinic. Colorcon Ventures, the investment arm of Colorcon, announced a strategic investment in Israel-based Phytolon. The biotechnology start-up uses precision fermentation to develop natural colorants. The investment underscores Colorcon’s commitment to next-generation coloring technologies that support cleaner-label formulations and innovation in oral solid dosage coatings.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Evonik launches MaxiPure Polysorbate 80; Asahi Kasei expands its portfolio The quarter saw continued innovation in high-purity and injectable-grade excipients. Evonik introduced MaxiPure Polysorbate 80, a high-purity injectable-grade surfactant designed for biologics and parenteral formulations. This excipient addresses key challenges such as protein stability, viral inactivation, and the solubilization of hydrophobic APIs, while meeting regulatory expectations across global markets. Asahi Kasei expanded its Sonanos portfolio of excipients with two new products — Sonanos PG (optimized for sustained release of biologics and peptides while supporting patient-friendly dosing)  and Sonanos DS (developed to enhance solubility of poorly water-soluble APIs). These additions reflect growing industry demand for dosage optimization, stability, and specialized delivery of complex molecules. Gangwal Healthcare operates EXCiPACT-certified GMP facilities and offers a broad range of functional excipients, including co-processed blends like ProBlend, Starlose, and Microlose. Its excipients, including Solvostar (sodium starch glycolate) and Sallyso (croscarmellose sodium), support enhanced tablet disintegration and drug release. The company also provides taste-masking agents such as SucreX (sucralose) and CutCal (neotame), supporting the development of patient-friendly oral dosage forms.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Colorcon, Gattefossé, Croda, Roquette, Clariant expand manufacturing capacities Manufacturing investments and facility expansions remained a key trend during Q3 2025. Colorcon inaugurated a new state-of-the-art, film coating manufacturing facility in Johor, Malaysia. The site incorporates energy-efficient systems and advanced production technologies to strengthen Colorcon’s functional-excipient supply network across Asia. Gattefossé opened a new lipid-based excipient facility in Texas (US), marking a strategic expansion of its North American manufacturing footprint. Croda International expanded its Leek, UK facility with a lipid system synthesis unit and enhanced R&D capabilities. The site will support the launch of Super Refined Poloxamer 188, a highly purified fast-dissolving granular excipient. Roquette announced the opening of a dedicated innovation center in São Paulo, Brazil, strengthening its engagement with regional drug developers. Clariant expanded its Daya Bay, China facility, adding a second spray tower dedicated to pharmaceutical excipient production. The upgraded site increases capacity for excipients used in laxatives and other formulations. BASF also strengthened its commitment to biopharma and pharmaceutical ingredients with a new GMP Solution Center in Michigan (US). The facility expands BASF’s network of poloxamer (a synthetic polymer) manufacturing sites. With state-of-the-art clean room packaging and high-sensitivity analytical testing, this new facility will enable close collaboration with BASF’s customers on customized chemistries for product development.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   India mandates excipient disclosure; new rules to apply from March 2026  India has made it mandatory to disclose excipient details from March 2026 under the country’s new Drugs (2nd Amendment) Rules, 2025. This applies to Schedule H2 medicines. The final notification expands earlier draft requirements by mandating qualitative excipient details in QR codes on product packaging. This should enhance transparency and support patient safety. Meanwhile, US pharmaceutical groups have responded to the US Food and Drug Administration’s draft guidance proposing simplified pathways for replacing color additives in drug products. Industry associations have supported draft guidance, noting that it reduces regulatory burden while maintaining product quality and consistency.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Our view While the fast-growing generics market is creating demand for cost-effective and versatile excipients, the market is also witnessing innovations tailored to the specialized needs of biologics and biosimilars. India is poised to become a key player in the global excipient market, supported by the rapid growth in its generic drug industry, expansion of its health infrastructure and increasing investments in R&D. The new excipient-disclosure rules, therefore, are likely to benefit the global excipient industry by improving transparency and strengthening quality ecosystems.
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    Impressions: 6067

    https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-evonik-launches-high-purity-excipients-india-mandates-disclosures-from-march-2026

    #PharmaFlow by PHARMACOMPASS
    20 Nov 2025
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    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 
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    Impressions: 3770

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

    #PharmaFlow by PHARMACOMPASS
    13 Nov 2025
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    Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

    Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

    The pharmaceutical excipients market saw significant strategic consolidations, technological developments, and regulatory adaptations in 2025. Globally, the pharmaceutical excipients sector is growing at a compound annual growth rate of 6.6 percent, and was valued at US$ 8.85 billion in 2024. It is projected to reach US$ 14.77 billion by 2032.This year, the sector is witnessing technological advancements, regulatory evolution, and strategic business realignments. North America continues to dominate the global excipients landscape, with a 39.8 percent market share. The Asia-Pacific region is the fastest-growing segment with a substantial 30.4 percent market share, driven by increasing investments in pharmaceutical manufacturing, growing demand for cost-effective drugs, and rising healthcare expenditure across developing economies.Major excipient providers include BASF, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, DuPont, Evonik, Seqens, Actylis, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Kewpie Corporation, Boai NKY Pharmaceuticals, ICE Pharma, Roquette, Nanjing Well Pharmaceutical, Minakem, Ashland Global, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Roquette restructures after buying IFF Pharma; Colorcon partners ASHA CelluloseIn May, Roquette completed its acquisition of IFF Pharma Solutions. Valued at up to US$ 2.85 billion in enterprise value, this transaction represents a major consolidation in the pharmaceutical excipients market. The acquisition significantly enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide. Roquette announced a comprehensive, new organizational structure following the acquisition, indicating the company’s commitment to integrate IFF Pharma Solutions’ capabilities seamlessly into its existing operations. This consolidation creates a more robust platform for addressing the growing demand for specialized excipients in complex drug formulations, particularly as the industry moves towards more personalized approaches to medicines.So far, the year has also witnessed some strategic alliances, such as Colorcon’s partnership with ASHA Cellulose. As part of the deal, Colorcon will become the exclusive representative for two ASHA products — ASHACEL and ASHAKOTE — throughout Europe, the Middle East, Africa, Northeast Asia and Southeast Asia.Brenntag Specialties has announced an exclusive distribution agreement with MEGGLE Excipients to expand market reach. This collaboration makes available a broad portfolio of over 30 high-quality lactose-based excipients for various applications in the pharmaceutical industries across the Netherlands, Belgium, Norway, Finland, and Sweden.The portfolio’s versatility offers optimal solutions for a wide range of pharmaceutical applications, including tableting through both granulation and direct compression, powder preparations, and dry powder inhalation. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)WHO, FDA drive new standards with GMP guidelines; Pfanstiehl launches injectable-grade glycineIn March, the World Health Organization had put out a publication titled “Good Manufacturing Practices for Excipients used in Pharmaceutical Products.” WHO’s excipient GMP guideline emphasizes modern quality management principles, comprehensive risk assessment protocols, and supplier qualification procedures for excipients across all stages of production, storage, and distribution.Meanwhile, the US Food and Drug Administration (FDA) has proposed amendments to the Food, Drug, and Cosmetic Act as part of its FY 2025 legislative proposals, specifically targeting supply chain transparency for high-risk excipients. The FDA proposal would require certain excipients designated as high-risk to carry labeling that identifies the original manufacturer’s name and address. This initiative addresses what FDA has identified as a lack of transparency in excipient supply chains.In April, IFF Pharma Solutions launched Low Nitrite METHOCEL hydroxypropyl methylcellulose (HPMC). This innovative product is specifically designed to reduce the risk of nitrosamine formation in finished pharmaceutical dosages, addressing one of the most pressing concerns in contemporary pharmaceutical manufacturing.Pfanstiehl, a global leader in high-purity excipient manufacturing, announced the launch of its High Purity Low Endotoxin Low Metals (HPLE-LM) injectable-grade glycine. This multi-compendial glycine is specifically engineered for use in biologics, vaccines, and the downstream purification of monoclonal antibodies (mAbs). Manufactured under ICH-Q7 cGMP regulations at Pfanstiehl’s advanced facility in Waukegan, Illinois, the product meets stringent global pharmacopeial standards. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Shin-Etsu Chemical invests in Japan, Germany to expand cellulose productionIn March, Shin-Etsu Chemical announced investments in pharmaceutical cellulose business operations in Japan and Europe, thereby showing significant commitment to market expansion. The company is making substantial investments at two key bases: the subsidiary SE Tylose GmbH in Germany, and the Naoetsu Plant in Joetsu, Japan. In Germany, a new production facility for the pharmaceutical excipient L-HPC will be built adjacent to the existing facility, creating a dual base with the Naoetsu Plant. The excipients market in 2025 has seen innovation in functional applications. Research on BENEO’s Palatinose as a bedtime drink shows that it improves aspects of sleep and represents an innovative approach to excipient functionality. Palatinose is a naturally sourced, smart carbohydrate that provides full carbohydrate energy in a more balanced way, thanks to its low-glycemic profile.Gangwal Healthcare, with its EXCiPACT-certified GMP facilities and a robust portfolio of co-processed excipients like ProBlend, Starlose, and Microlose, is actively contributing to the pharmaceutical industry’s demand for functional excipients. The company also offers cellulose-based excipients such as Solvostar (Sodium Starch Glycolate) and Sallyso (Croscarmellose Sodium), designed to improve tablet disintegration and drug release profiles in oral solid dosage forms.Evonik announced a partnership with South Korea–based CDMO ST Pharm to expand its RNA and nucleic acid delivery services. This collaboration enables Evonik to integrate customized nucleic acids from ST Pharm seamlessly with its lipid and lipid nanoparticle (LNP) development and fill-and-finish services. This streamlined approach means that pharmaceutical companies can reduce complexity and increase speed-to-market for nucleic acid therapeutics. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Our viewThe pharmaceutical excipients market in 2025 is being shaped by several key trends including the development of multifunctional excipients that can simultaneously improve solubility, bioavailability, and control drug release in increasingly complex formulations.Moreover, the expanding generic medicines market is creating demand for cost-effective, versatile excipients. The growing importance of biologics and biosimilars is driving innovation in specialized excipients designed to maintain the stability and efficacy of these complex therapeutic products throughout their lifecycle. And nanotechnology continues to enable advanced nano-excipients for enhanced drug delivery and efficacy.In addition to these trends, we also notice a shift towards natural and plant-based excipients that is driven by sustainability concerns and potential biocompatibility benefits. 
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    #PharmaFlow by PHARMACOMPASS
    29 May 2025
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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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    Impressions: 15723

    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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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    24 Oct 2024
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    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   
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    Pfanstiehl Launches Pure Glycine Injectable Grade Excipient
    Pfanstiehl Launches Pure Glycine Injectable Grade Excipient

    25 Jan 2025

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    https://pfanstiehl.com/wp-content/uploads/2025/01/Glycine-GMP-Excipient-High-Purity-Low-Endotoxin-Low-Metals-Press-Release-012125.pdf

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    25 Jan 2025
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    Pfanstiehl Launches Low-Endotoxin Glucose for Biologics
    Pfanstiehl Launches Low-Endotoxin Glucose for Biologics

    28 Nov 2024

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    https://pfanstiehl.com/wp-content/uploads/2025/01/Glucose-Dextrose-Press-Release-JTM-102524.pdf

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    28 Nov 2024
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    Pfanstiehl Launches Succinic Acid Excipient Grade
    Pfanstiehl Launches Succinic Acid Excipient Grade

    11 Oct 2024

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    11 Oct 2024
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    Pfanstiehl Launches Parenteral Grade Histidine For Biopharma
    Pfanstiehl Launches Parenteral Grade Histidine For Biopharma

    25 Jun 2020

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    https://www.pharmaexcipients.com/wp-content/uploads/2020/07/Histidine-Pfanstiehl.pdf

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    25 Jun 2020
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    Pfanstiehl Unveils Parenteral Sodium Succinate For Formulations
    Pfanstiehl Unveils Parenteral Sodium Succinate For Formulations

    04 Sep 2018

    // PHARMAC BR

    https://www.pharmaceutical-business-review.com/contractors/pfanstiehl/news/pfanstiehl-launches-parenteral-grade-sodium-succinate/

    PHARMAC BR
    04 Sep 2018
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    Pfanstiehl Launches New cGMP-Produced, Parenteral Grade Arginine
    Pfanstiehl Launches New cGMP-Produced, Parenteral Grade Arginine

    20 Jul 2018

    // PHARMA BR

    https://www.pharmaceutical-technology.com/contractors/excipients/pfanstiehl/pressreleases/pfanstiehl-launches-new-cgmp-produced-parenteral-grade-arginine/

    PHARMA BR
    20 Jul 2018
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    Excipients

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    01

    Brand Name : D-Galactose

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    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral, Thickeners and Stabilizers

    Excipient Details : D-galactose is used as a stabilizer and cell metabolism modulator in the optimization of protein therapeutics bioproduction.

    Pharmacopoeia Ref : NF, EP

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : Galactose

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    Pfanstiehl Galactose
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    02

    Brand Name : D-Mannitol

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    Dosage Form : Injectable / Parenteral, Tablet

    Grade : Parenteral, Oral

    Pfanstiehl

    Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

    Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.

    Pharmacopoeia Ref : USP, EP, BP, JP, ChP

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : Mannitol

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    Pfanstiehl Mannitol
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    03

    Brand Name : L-Arginine

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    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral, Thickeners and Stabilizers

    Excipient Details : L-Arginine is used as a cryoprotective agent and solution additive to stabilize proteins. It is used in injectable biologic & vaccine formulations.

    Pharmacopoeia Ref : USP, EP, JP, ChP

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : L-Arginine Excipient

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    L-Arginine
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    04

    Brand Name : L-Glutamine

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    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral

    Excipient Details : L-glutamine is used as a supplement in cell culture media, protein purification, tissue engineering, and recombinant protein production.

    Pharmacopoeia Ref : USP, JP, ChP

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : L-Glutamine Excipient

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    Pfanstiehl L-Glutamine
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    05

    Brand Name : L-Histidine

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    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral

    Excipient Details : Histidine is used in biotherapeutic formulations and protects monoclonal antibodies in both the liquid and lyophilized state.

    Pharmacopoeia Ref : USP, EP, BP, JP, ChP

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : L-Histidine Excipient

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    Pfanstiehl L-Histidine
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    06

    Brand Name : L-Methionine

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    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral

    Excipient Details : L-methionine is used as a supplement in cell culture media, in protein purification processes, and in the production of recombinant proteins.

    Pharmacopoeia Ref : USP, EP, BP, JP, ChP

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : DL-Methionine Excipient

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    Pfanstiehl L-Methionine
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    07

    Brand Name : Maltose Monohydrate

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    Dosage Form : Injectable / Parenteral, Solution

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral, Thickeners and Stabilizers

    Excipient Details : Maltose is used as a stabilizer in infusion & blood fractionation, biologic injectable & vaccine. It prevents protein aggregation in IVIG solutions.

    Pharmacopoeia Ref : USP, NF, JP, ChP

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : Maltose Monohydrate Excipient

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    Maltose Monohydrate
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    08

    Brand Name : Mannose

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    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral

    Excipient Details : Mannose is used to optimize protein therapeutics bioproduction and as a key component to ensure consistency of therapeutic glycosylation and potency.

    Pharmacopoeia Ref : N/A

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : D-Mannose

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    Pfanstiehl Mannose
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    09

    Brand Name : Sodium Gluconate

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    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral

    Excipient Details : Sodium gluconate is used as a buffering agent in large volume parenteral formulations.

    Pharmacopoeia Ref : USP

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : Sodium Gluconate Excipient

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    Pfanstiehl Sodium Gluconate
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    10

    Brand Name : Sodium Succinate

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    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Pfanstiehl

    Application : Parenteral

    Excipient Details : Sodium succinate hexahydrate is used as a buffering agent in biopharmaceutical parenteral formulations including vaccines.

    Pharmacopoeia Ref : USP, NF, JPE

    Technical Specs : Low Endotoxin, Low Metals

    Ingredient(s) : Sodium Succinate Excipient

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    Pfanstiehl Sodium Succinate
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    Pfanstiehl is a supplier offers 19 products (APIs, Excipients or Intermediates).

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