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    Company profile for Formosa Laboratories

    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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    About

    Formosa Laboratories Inc. founded in Taiwan since 1995 started with API business and has been serving customers worldwide. As an established API manufacturer receiving GMP inspections from regulatory authorities around the world, Formosa now provides CDMO service extending from APIs and ADCs (Antibody Drug Conjugates) to cytotoxic and non-cytotoxic injectables of aseptic liquid filling and lyophilization. Formosa Laboratories ...
    Formosa Laboratories Inc. founded in Taiwan since 1995 started with API business and has been serving customers worldwide. As an established API manufacturer receiving GMP inspections from regulatory authorities around the world, Formosa now provides CDMO service extending from APIs and ADCs (Antibody Drug Conjugates) to cytotoxic and non-cytotoxic injectables of aseptic liquid filling and lyophilization. Formosa Laboratories is able to offer full-service GMP manufacturing for drug substance, ADCs and drug product with its API and injectable facilities that accommodates small molecules, biologics and ADCs etc.

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    CONTACT DETAILS

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    Formosa LaboratoriesTaiwan Flag
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    Taiwan
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    No. 36, Hoping Street, Louchu, Taoyuan 338002
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

    Impressions: 5060

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 
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    Impressions: 2074

    https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

    #PharmaFlow by PHARMACOMPASS
    30 Jan 2025
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    NEWS #PharmaBuzz

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    Formosa Labs Q3 Earnings: NT$0.19 EPS Vs NT$0.95 Loss In 2023
    Formosa Labs Q3 Earnings: NT$0.19 EPS Vs NT$0.95 Loss In 2023

    18 Nov 2024

    // PRESS RELEASE

    https://simplywall.st/stocks/tw/pharmaceuticals-biotech/twse-4746/formosa-laboratories-shares/news/formosa-laboratories-third-quarter-2024-earnings-eps-nt019-v

    PRESS RELEASE
    18 Nov 2024
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    Formosa Labs Passes FDA Inspection For Breast Cancer Drug
    Formosa Labs Passes FDA Inspection For Breast Cancer Drug

    19 Sep 2024

    // PRESS RELEASE

    https://www.taiwan-healthcare.org/en/news-detail?id=0sk1c4ep3bulsje9

    PRESS RELEASE
    19 Sep 2024
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    Formosa Passes 1st FDA GMP Check For High-Potency Injectables
    Formosa Passes 1st FDA GMP Check For High-Potency Injectables

    16 Sep 2024

    // PRESS RELEASE

    https://www.formosalab.com/news-list-page608

    PRESS RELEASE
    16 Sep 2024
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    Formosa Pharma Licenses Clobetasol Ophthalmic Drug To Apotex
    Formosa Pharma Licenses Clobetasol Ophthalmic Drug To Apotex

    05 Sep 2024

    // PRESS RELEASE

    https://www.formosalab.com/news-list-page612

    PRESS RELEASE
    05 Sep 2024
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    Formosa Labs Completes Acquisition of Synchem
    Formosa Labs Completes Acquisition of Synchem

    04 Jun 2024

    // CONTRACT PHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2024-06-04/formosa-labs-completes-acquisition-of-synchem/

    CONTRACT PHARMA
    04 Jun 2024
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    Formosa Acquires Synchem, Expands North American CDMO Footprint
    Formosa Acquires Synchem, Expands North American CDMO Footprint

    03 Jun 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/formosa-laboratories-completes-the-acquisition-of-synchem-to-expand-north-american-cdmo-footprint-302160495.html

    PR NEWSWIRE
    03 Jun 2024
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    ALL APIs

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    01

    Calcitriol

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

    VMX
    Not Confirmed
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    Calcitriol

    Taiwan

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

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    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-27

    Pay. Date : 2012-12-03

    DMF Number : 18227

    Submission : 2005-03-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-150 - Rev 02

    Issue Date : 2024-12-18

    Type : Chemical

    Substance Number : 883

    Status : Valid

     JDMF arrow-down
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    Registration Number : 228MF10187

    Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan

    Initial Date of Registration : 2016-09-26

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0003

    Start Marketing Date : 2014-09-26

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hanmi Pharmaceutical Co., Ltd.

    Registration Date : 2022-01-12

    Registration Number : 20210412-209-J-577(1)

    Manufacturer Name : Formosa Laboratories, Inc.

    Manufacturer Address : No. 36 & 36-1 Hoping Street, Louchu Country, Taoyuan 33842, Taiwan

     VMF Others AUDIT
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    02

    Temozolomide

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

    VMX
    Not Confirmed
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    Temozolomide

    Taiwan

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-25

    Pay. Date : 2012-12-03

    DMF Number : 23158

    Submission : 2009-10-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-245 - Rev 01

    Issue Date : 2024-04-26

    Type : Chemical

    Substance Number : 2780

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10143

    Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan

    Initial Date of Registration : 2016-08-03

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0015

    Start Marketing Date : 2006-12-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Alvogen Korea Co., Ltd.

    Registration Date : 2015-08-11

    Registration Number : Number 1367-1-ND

    Manufacturer Name : Formosa Laboratories, Inc. Louchu Plant@[Starting Material Manufacturing Plant]Azide Chemical Co., Ltd._x000D_ _x000D_

    Manufacturer Address : No. 36 & 36-1 Hoping Street, Louchu Country, Taoyuan 33842, Taiwan@Norland Shizhuang Town, Rugao City, Juangsu Province, China

     VMF Others AUDIT
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    03

    Calcifediol

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

    VMX
    Not Confirmed
    arrow

    Calcifediol

    Taiwan

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

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    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33640

    Submission : 2019-05-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-163 - Rev 02

    Issue Date : 2024-08-27

    Type : Chemical

    Substance Number : 1295

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0065

    Start Marketing Date : 2019-09-06

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Calcipotriol

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

    VMX
    Not Confirmed
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    Calcipotriol

    Taiwan

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

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    VMX
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-15

    Pay. Date : 2013-03-01

    DMF Number : 19415

    Submission : 2006-05-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-187 - Rev 00

    Issue Date : 2016-09-09

    Type : Chemical

    Substance Number : 2284

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0005

    Start Marketing Date : 2006-03-31

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Calcipotriol

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

    VMX
    Not Confirmed
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    Calcipotriol

    Taiwan

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-23

    Pay. Date : 2013-09-26

    DMF Number : 23267

    Submission : 2009-11-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-243 - Rev 01

    Issue Date : 2018-06-29

    Type : Chemical

    Substance Number : 2011

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0005

    Start Marketing Date : 2006-03-31

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Leflunomide

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

    VMX
    Not Confirmed
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    Leflunomide

    Taiwan

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-07

    Pay. Date : 2016-08-04

    DMF Number : 16038

    Submission : 2002-06-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-035 - Rev 01

    Issue Date : 2018-02-09

    Type : Chemical

    Substance Number : 2330

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0001

    Start Marketing Date : 2014-01-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    07

    Levonorgestrel

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

    VMX
    Not Confirmed
    arrow

    Levonorgestrel

    Taiwan

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

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    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-27

    Pay. Date : 2012-12-03

    DMF Number : 21634

    Submission : 2008-05-20

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10159

    Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan

    Initial Date of Registration : 2016-08-10

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0018

    Start Marketing Date : 2013-02-22

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Linezolid

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

    VMX
    Not Confirmed
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    Linezolid

    Taiwan

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

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    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-10

    Pay. Date : 2013-03-01

    DMF Number : 25700

    Submission : 2012-01-09

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 302MF10099

    Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan

    Initial Date of Registration : 2020-08-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0047

    Start Marketing Date : 2014-12-02

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Montelukast Sodium

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

    VMX
    Not Confirmed
    arrow

    Montelukast Sodium

    Taiwan

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-22

    Pay. Date : 2012-12-03

    DMF Number : 21702

    Submission : 2008-06-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-278 - Rev 00

    Issue Date : 2021-07-23

    Type : Chemical

    Substance Number : 2583

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0016

    Start Marketing Date : 2006-12-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Apraclonidine Hydrochloride

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

    VMX
    Not Confirmed
    arrow

    Apraclonidine Hydrochloride

    Taiwan

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

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    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16768

    Submission : 2003-08-18

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Contact Formosa Laboratories, Inc and get a quotation

    Formosa Laboratories, Inc is a supplier offers 62 products (APIs, Excipients or Intermediates).

    Find a price of Calcitriol bulk with DMF, CEP, JDMF offered by Formosa Laboratories, Inc

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