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    Company profile for Symed Labs

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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    xyz-pharma-m-2024-10-07

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    With Fermion, start the journey of your innovative API.

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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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    xyz-pharma-m-2024-10-07

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    EVENTS

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    About

    Symed Labs Ltd is a leading Hyderabad based manufacturer of Active Pharmaceutical Ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services. We are more than 300 employees strong and our core competence is in the application of strong process chemistry to manufacturing in a regulatory environment. For the past 15 years, Symed has been at the forefront of facilitati...
    Symed Labs Ltd is a leading Hyderabad based manufacturer of Active Pharmaceutical Ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services. We are more than 300 employees strong and our core competence is in the application of strong process chemistry to manufacturing in a regulatory environment. For the past 15 years, Symed has been at the forefront of facilitating and accelerating drug development (and GMP manufacturing) of APIs. The company's technical and scientific teams provide reliable solutions and services to the global pharmaceutical industry.

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    CONTACT DETAILS

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    #8-2-293/174/3, Beside BN Reddy Colony, Road No.14, Banjara Hills, Hyderabad-5...
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    +91 40 23635000
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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  

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    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    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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    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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    NEWS #PharmaBuzz

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    Linezolid : Symed Labs, Hetero USA vs. Amneal Pharmaceuticals
    Linezolid : Symed Labs, Hetero USA vs. Amneal Pharmaceuticals

    15 Sep 2018

    // PATENT LITIGATION

    https://insight.rpxcorp.com/litigation_documents/13058146

    PATENT LITIGATION
    15 Sep 2018
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    Linezolid : Symed Labs & Hetero USA v. Amneal Pharmaceuticals
    Linezolid : Symed Labs & Hetero USA v. Amneal Pharmaceuticals

    06 Sep 2018

    // PATENT LITIGATION

    https://www.pharmacompass.com/pdf/news/linezolid-symed-labs-hetero-usa-v-amneal-pharmaceuticals-1536300881.pdf

    PATENT LITIGATION
    06 Sep 2018
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    ALL APIs

    read-moreClick the button for full data set
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    01

    Brimonidine Tartrate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Brimonidine Tartrate

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22230

    Submission : 2008-12-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2018-124 - Rev 00

    Issue Date : 2020-05-14

    Type : Chemical

    Substance Number : 2760

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-10-07

    Valid Till : 2022-09-08

    Written Confirmation Number : WC-0072

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66022-0110

    Start Marketing Date : 2013-08-23

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Product
    Web Link

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    Market
    Place

    02

    Deferasirox

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

    Antibody Engineering
    Not Confirmed
    arrow

    Deferasirox

    India

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

    arrow
    Antibody Engineering
    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 : 2019-12-30

    Pay. Date : 2019-12-16

    DMF Number : 31877

    Submission : 2019-11-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-038 - Rev 00

    Issue Date : 2023-07-07

    Type : Chemical

    Substance Number : 2933

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-09-12

    Valid Till : 2022-09-11

    Written Confirmation Number : WC-0451

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66022-0301

    Start Marketing Date : 2017-05-18

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Hydroxyzine Dihydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Hydroxyzine Dihydrochloride

    India

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

    arrow
    Antibody Engineering
    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 : 2016-11-18

    Pay. Date : 2016-10-24

    DMF Number : 19596

    Submission : 2006-07-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-186 - Rev 00

    Issue Date : 2021-07-12

    Type : Chemical

    Substance Number : 916

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-09-12

    Valid Till : 2022-09-11

    Written Confirmation Number : WC-0451

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66022-0104

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Ketorolac Trometamol

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

    Antibody Engineering
    Not Confirmed
    arrow

    Ketorolac Trometamol

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-03

    Pay. Date : 2013-03-04

    DMF Number : 26870

    Submission : 2013-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-046 - Rev 00

    Issue Date : 2021-06-04

    Type : Chemical

    Substance Number : 1755

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-10-07

    Valid Till : 2022-09-08

    Written Confirmation Number : WC-0072

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66022-0117

    Start Marketing Date : 1992-11-09

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : IMCD Korea Co., Ltd.

    Registration Date : 2021-05-14

    Registration Number : 20200227-61-C-384-14(1)

    Manufacturer Name : Symed Labs Limited(Unit II) @Symed Labs Limited(Unit VI)

    Manufacturer Address : Plot-25/B, Phase III, IDA Jeedimetla (V), Quthbullapur (M), Medchal-Malkajgiri District-500 055 Telangana State India@Sy. No. 744, 745, 750, 751, 752 & 753, Mandollagudem Village Choutuppal Mandal, Yadadri District, Telangana, India

     VMF Others AUDIT
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    Market
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    05

    Levocetirizine Dihydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Levocetirizine Dihydrochloride

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-06-02

    Pay. Date : 2017-04-27

    DMF Number : 22286

    Submission : 2008-12-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-050 - Rev 00

    Issue Date : 2024-08-26

    Type : Chemical

    Substance Number : 3115

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-10-07

    Valid Till : 2022-09-08

    Written Confirmation Number : WC-0072

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66022-0108

    Start Marketing Date : 2008-01-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    Market
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    06

    Meclizine Hydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Meclizine Hydrochloride

    India

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

    arrow
    Antibody Engineering
    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 : 2015-10-01

    Pay. Date : 2015-09-21

    DMF Number : 25418

    Submission : 2011-10-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-242 - Rev 00

    Issue Date : 2021-09-10

    Type : Chemical

    Substance Number : 622

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-10-07

    Valid Till : 2022-09-08

    Written Confirmation Number : WC-0072

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66022-0114

    Start Marketing Date : 1982-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    07

    Rivaroxaban

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

    Antibody Engineering
    Not Confirmed
    arrow

    Rivaroxaban

    India

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

    arrow
    Antibody Engineering
    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 : 2015-04-21

    Pay. Date : 2014-12-11

    DMF Number : 28807

    Submission : 2014-11-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-091 - Rev 01

    Issue Date : 2024-10-04

    Type : Chemical

    Substance Number : 2932

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-12-02

    Valid Till : 2022-08-08

    Written Confirmation Number : WC-0382

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66022-0203

    Start Marketing Date : 2011-07-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2020-07-07

    Registration Number : Thu21-11-ND

    Manufacturer Name : Symed Labs Ltd(Unit-I)

    Manufacturer Address : Sy. No. 353, Domadugu Village Gummadidala (Mandal), Sangreddy District Telangana State, India

     VMF Others AUDIT
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    Market
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    08

    Tizanidine HCl

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

    Antibody Engineering
    Not Confirmed
    arrow

    Tizanidine HCl

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-02-09

    Pay. Date : 2022-01-27

    DMF Number : 33900

    Submission : 2019-07-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-256 - Rev 00

    Issue Date : 2023-01-05

    Type : Chemical

    Substance Number : 2578

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2021-06-22

    Valid Till : 2022-08-08

    Written Confirmation Number : WC-0382A4

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 66022-0202

    Start Marketing Date : 1996-11-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Klasia Co., Ltd.

    Registration Date : 2021-10-19

    Registration Number : 20211019-209-J-1034

    Manufacturer Name : M/s.Symed Labs Ltd (Unit-Ⅰ)

    Manufacturer Address : Sy. No. 353, Domadugu Village Gummadidala (Mandal), Sangareddy (Dist.), Telangana State, India.

     VMF Others AUDIT
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    09

    Sertraline Hydrochloride

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

    Antibody Engineering
    Not Confirmed
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    Sertraline Hydrochloride

    India

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

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    Antibody Engineering
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-02-12

    Pay. Date : 2024-01-09

    DMF Number : 38163

    Submission : 2023-03-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-462 - Rev 00

    Issue Date : 2024-07-25

    Type : Chemical

    Substance Number : 1705

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Linezolid

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

    Antibody Engineering
    Not Confirmed
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    Linezolid

    India

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

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    Antibody Engineering
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-15

    Pay. Date : 2013-03-01

    DMF Number : 20269

    Submission : 2007-02-15

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-10-07

    Valid Till : 2022-09-08

    Written Confirmation Number : WC-0072

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66022-0103

    Start Marketing Date : 2000-04-18

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2021-03-10

    Registration Number : 20210310-209-J-868

    Manufacturer Name : Symed Labs Limited (Unit II)

    Manufacturer Address : Plot-25/B, Phase III, IDA Jeedimetla (V), Quthbullapur (M), Medchal-Malkajgiri District-500 055 Telangana State India

     VMF Others AUDIT
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    Inspections and registrations

    Upload your audits for free, ask us

    FDA

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    01

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
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    FDA Audited

    USA
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    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-10-22

    Symed Labs

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-10-22

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    02

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-03-28

    Symed Labs

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-03-28

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    03

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
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    FDA Audited

    USA
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    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-06-05

    Symed Labs

    City : Gummadidala

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-06-05

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    04

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-11-06

    Symed Labs

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-11-06

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    05

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-12-08

    Symed Labs

    City : Chityala

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-12-08

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    06

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-04

    Symed Labs

    City : Gummadidala

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-04

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    07

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-11

    Symed Labs

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-11

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    EDQM

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    01

    GMP Certified

    EU
    Antibody Engineering
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    GMP Certified

    EU
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    Antibody Engineering
    Not Confirmed

    Symed Labs

    Type : GMP Certificates

    Number : OGYI/9814-6...

    EudraGMDP Key : 11685

    Country : India

    Issue Date :

    Post Code : 500055

    NCA Ref : IN-A-SYME02

    City : Hyderabad

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    02

    GMP Certified

    EU
    Antibody Engineering
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Antibody Engineering
    Not Confirmed

    Symed Labs

    Type : GMP Certificates

    Number : OGYÉI/5122...

    EudraGMDP Key : 53716

    Country : India

    Issue Date : 2019-04-29

    Post Code : 500055

    NCA Ref : IN-A-SYME-01

    City : Hyderabad

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    03

    GMP Certified

    EU
    Antibody Engineering
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Antibody Engineering
    Not Confirmed

    Symed Labs

    Type : GMP Certificates

    Number : OGYÉI/9721...

    EudraGMDP Key : 50319

    Country : India

    Issue Date : 2018-10-01

    Post Code : 502313

    NCA Ref : IN-A-SYME02

    City : Gummadidala Mandal, San...

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    04

    GMP Certified

    EU
    Antibody Engineering
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Antibody Engineering
    Not Confirmed

    Symed Labs

    Type : GMP Certificates

    Number : OGYI/26154-...

    EudraGMDP Key : 36282

    Country : India

    Issue Date : 2016-07-15

    Post Code : 500055

    NCA Ref : IN-A-SYME-01

    City : Hyderabad

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    GDUFA

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    01

    GDUFA fees paid

    USA
    Antibody Engineering
    Not Confirmed
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    GDUFA fees paid

    USA
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    Paid in : 2019

    Symed Labs

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Symed Labs Limited (Unit-I)

    Business Address : Survey No.353, Domadugu (Vil...

    FEI Number : 3007164063

    Country : India

    Paid in : 2019

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    02

    GDUFA fees paid

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    GDUFA fees paid

    USA
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Paid in : 2019

    Symed Labs

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : SYMED LABS LIMITED (Unit-II)

    Business Address : Plot-25/B, Phase - III, I.D....

    FEI Number : 3005522065

    Country : India

    Paid in : 2019

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    03

    GDUFA fees paid

    USA
    Antibody Engineering
    Not Confirmed
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    GDUFA fees paid

    USA
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    Paid in : 2019

    Symed Labs

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : SYMED LABS LIMITED (Unit-IV)

    Business Address : Survey.No 163, 163/A & 164/A...

    FEI Number : 3012725393

    Country : India

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact Symed Labs and get a quotation

    Symed Labs is a supplier offers 88 products (APIs, Excipients or Intermediates).

    Find a price of Brimonidine Tartrate bulk with DMF, CEP offered by Symed Labs

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