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    Nanjing Well Pharma Tech Discloses Q1 Environmental Testing Data Report

    27 May 2024

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    Nanjing Well 's Second Quarter Environmental Protection Outsourcing Testing Report

    25 Sep 2023

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    Nanjing Well Biotechnology high—end biological products medical excipients industrialization device project

    21 Apr 2023

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    Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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    About

    Nanjing Well Pharmaceutical Group was established in 2000 & is committed to R&D & manufacture of pharmaceutical materials, base oils of advanced synthetic lubricants, etc. The group has 10 subsidiaries, which are distributed in Nanjing, Yangzhou, & other cities in China. Nanjing Well Pharmaceutical Technology is a wholly-owned subsidiary of the Group, & it is a new R&D & manufacturing center for pharmaceutical excipients & APIs. It is located in Nanjing Jiangbei New Material Science & Technology Park with 200+ employees & has 15 synthetic production lines which can achieve an annual output of >20,000 tons of pharmaceutical excipients & APIs.

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    Nanjing Well PharmaceuticalChina Flag
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    No.99, Changfenghe West Road, Chemical industrial Park, Nanjing, 210047
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    +86 02583172922
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    mj@wellnj.com
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    Product List 2024

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    MPLA & QS-21

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    DATA COMPILATION #PharmaFlow

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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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    NEWS #PharmaBuzz

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    Nanjing Well Pharma Tech Discloses Q1 Environmental Testing Data Report
    Nanjing Well Pharma Tech Discloses Q1 Environmental Testing Data Report

    27 May 2024

    // PRESS RELEASE

    http://www.wellnj.com/cms/gongsidongtai/391.html

    PRESS RELEASE
    27 May 2024
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    Nanjing Well 's Second Quarter Environmental Protection Outsourcing Testing Report
    Nanjing Well 's Second Quarter Environmental Protection Outsourcing Testing Report

    25 Sep 2023

    // PRESS RELEASE

    http://www.wellnj.com/cms/gongsidongtai/236.html

    PRESS RELEASE
    25 Sep 2023
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    Nanjing Well Biotechnology high—end biological products medical excipients industrialization device project
    Nanjing Well Biotechnology high—end biological products medical excipients industrialization device project

    21 Apr 2023

    // PRESS RELEASE

    http://www.wellnj.com/shownews.asp?id=322

    PRESS RELEASE
    21 Apr 2023
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    Analysis of general changes in the 20,000 tons of pharmaceutical excipients project of Nanjing well Pharmaceutical Technology
    Analysis of general changes in the 20,000 tons of pharmaceutical excipients project of Nanjing well Pharmaceutical Technology

    08 Jul 2022

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    http://www.wellnj.com/shownews.asp?id=308

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    08 Jul 2022
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    Polysorbate 80 (II) has successfully completed CEP certification and DMF filing
    Polysorbate 80 (II) has successfully completed CEP certification and DMF filing

    27 Apr 2022

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    http://www.wellnj.com/shownews.asp?id=304

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    27 Apr 2022
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    The special job fair for production and scientific research was successfully heId—the 2020 Recruitment Fair of Chengxian College of Southeast University
    The special job fair for production and scientific research was successfully heId—the 2020 Recruitment Fair of Chengxian College of Southeast University

    20 May 2020

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    http://www.wellnj.com/shownews.asp?id=288

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    20 May 2020
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    Excipients

    Discover the DDS // excipients from this company

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    01

    Polysorbate 80

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35699

    Submission : 2021-04-14

    Status : Active

    Type : IV

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-419 - Rev 00

    Issue Date : 2022-04-01

    Type :

    Substance Number :

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Polysorbate 20

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36565

    Submission : 2022-07-05

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Listed Products

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    01

    Brand Name : Benzyl Alcohol

    China
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet

    Grade : Parenteral, Oral, Topical

    Nanjing Well Pharmaceutical

    Application : Parenteral, Solubilizers, Topical

    Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.

    Pharmacopoeia Ref : ChP/USP/EP/JP

    Technical Specs : NA

    Ingredient(s) : Benzyl Alcohol

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    Nanjing Well Benzyl Alcohol
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    02

    Brand Name : Castor Oil

    China
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Nanjing Well Pharmaceutical

    Application : Parenteral

    Excipient Details : Castor oil is used as an oily solvent in parenteral dosage forms.

    Pharmacopoeia Ref : USP/EP/JP

    Technical Specs : NA

    Ingredient(s) : Castor Oil Excipient

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    Nanjing Well Castor Oil
    ELCC
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    Excipients Web Link

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    03

    Brand Name : Crotamiton

    China
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Cream / Lotion / Ointment

    Grade : Topical

    Nanjing Well Pharmaceutical

    Application : Film Formers & Plasticizers, Thickeners and Stabilizers

    Excipient Details : Crotamiton is used as an ointment base, viscosity increasing agent and a plasticizer in various pharmaceutical topical dosage forms.

    Pharmacopoeia Ref : ChP/USP/EP

    Technical Specs : NA

    Ingredient(s) : Crotamiton Excipient

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    Crotamiton
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    04

    Brand Name : Dimethyl Dioctadecyl Ammo...

    China
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    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Nanjing Well Pharmaceutical

    Application : Parenteral

    Excipient Details : Dimethyl dioctadecyl ammonium bromide (DDAB) is used as vaccine adjuvants CAF01.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Dimethyl Dioctadecyl Ammonium Bromide DDAB

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    Dimethyl Dioctadecyl Ammonium Bromide
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    05

    Brand Name : Egg Yolk Lecithin

    China
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Emulsion, Injectable / Parenteral

    Grade : Parenteral

    Nanjing Well Pharmaceutical

    Application : Emulsifying Agents, Parenteral, Solubilizers

    Excipient Details : Egg yolk lecithin is used as an emulsifier, solubilizer & liposome membrane material in fat emulsions, lipid microspheres, mixed micelles & liposomes.

    Pharmacopoeia Ref : ChP/USP/EP

    Technical Specs : NA

    Ingredient(s) : Egg Yolk Lecithin

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    06

    Brand Name : Glyceryl Dioleate

    China
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Nanjing Well Pharmaceutical

    Application : Parenteral

    Excipient Details : Glyceryl dioleate is used as modified release materials for common and complex injections.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Glyceryl Dioleate

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    Glyceryl Dioleate
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    07

    Brand Name : Lactose Monohydrate

    China
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Nanjing Well Pharmaceutical

    Application : Parenteral

    Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.

    Pharmacopoeia Ref : ChP/USP/EP/JP

    Technical Specs : NA

    Ingredient(s) : Lactose Monohydrate

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    Nanjing Well Lactose Monohydrate
    ELCC
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    08

    Brand Name : Laurel Sorbitan (Span 20)

    China
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Tablet

    Grade : Oral, Topical

    Nanjing Well Pharmaceutical

    Application : Emulsifying Agents, Solubilizers, Thickeners and Stabilizers, Topical

    Excipient Details : Laurel sorbitan (Span 20) is used as stabilizer, emulsifier & solubilizer in oral & topical formulations such as tablets, creams, lotions, gels, etc.

    Pharmacopoeia Ref : ChP/USP/EP

    Technical Specs : NA

    Ingredient(s) : Laurel Sorbitan

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    Laurel Sorbitan (Span 20)
    ELCC
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    Excipients Web Link

    Market Place

    09

    Brand Name : MPLA

    China
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Nanjing Well Pharmaceutical

    Application : Parenteral

    Excipient Details : MPLA is a highly specific TLR4 agonist that activates the innate immune response, induces the production of cytokines, and activate specific T cells.

    Pharmacopoeia Ref : NA

    Technical Specs : Water content, microbial limits, residual solvents meet the requirements for vaccine use; Sealed & s...

    Ingredient(s) : Monophosphoryl Lipid A

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    MPLA
    ELCC
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    Excipients Web Link

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    10

    Brand Name : Octyldodecanol

    China
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    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Cream / Lotion / Ointment

    Grade : Topical

    Nanjing Well Pharmaceutical

    Application : Topical

    Excipient Details : Octyldodecanol is used as a solvent in topical dosage forms.

    Pharmacopoeia Ref : USP/EP

    Technical Specs : NA

    Ingredient(s) : Octyldodecanol

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    Octyldodecanol
    ELCC
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    Excipients Web Link

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