menu
    • menu

    Company profile for GLAND PHARMA LIMITED

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

    Virtual Booth

    Contact Supplier

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

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2024-10-07

    Virtual Booth

    Contact Supplier

    With Fermion, start the journey of your innovative API.

    Virtual Booth

    Contact Supplier

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

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2024-10-07

    Virtual Booth

    Contact Supplier

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

    Update your Virtual Booth on PharmaCompass, ask us

    About

    A globally renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his time. Since inception, Gland Pharma stands testimony to the founder’s exemplary commitment to Quality, having emerged as a global player with presence in about 90 countries in five continents. We have a wide range of injectables, including vial...
    A globally renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his time. Since inception, Gland Pharma stands testimony to the founder’s exemplary commitment to Quality, having emerged as a global player with presence in about 90 countries in five continents. We have a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions and ophthalmic solutions.

    List your booth number for exhibitions, ask us

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    GLAND PHARMA LIMITEDindia-flag Flag
    Country
    Country
    India
    Address
    Address
    6-3-865/1/2, Greenland Apartments Ameerpet, Hyderabad - 500016
    Telephone
    Telephone
    +91-40-66621010
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://glandpharma.com/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

    Upload your Marketing & Sales content on your company Virtual Booth, click HERE.

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    Default Event

    DCAT Week

    Not Confirmed

    envelop Contact Supplier

    DCAT Week

    Post an Enquiry

    Meeting

    Digital content

    Create Content with PharmaCompass, ask us

    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: 4587

    subscribeSubscribe

    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
    Share info Share

    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 400

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-bora-polpharma-make-acquisitions-evonik-euroapi-porton-announce-technological-expansions

    #PharmaFlow by PHARMACOMPASS
    19 Dec 2024
    Share Share

    NEWS #PharmaBuzz

    read-more
    read-more
    Gland Pharma Jumps 5% On FDA Nod For Vitamin-K Drug
    Gland Pharma Jumps 5% On FDA Nod For Vitamin-K Drug

    12 Dec 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/news/gland-pharma-jumps-5-after-usfda-nod-for-vitamin-k-deficiency-drug-124121200167_1.html

    BUSINESS STD
    12 Dec 2024
    Share Share
    Gland Pharma`s Generics Phytonadione Receives Approval in US
    Gland Pharma`s Generics Phytonadione Receives Approval in US

    10 Dec 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217386

    FDA
    10 Dec 2024
    Share Share
    Gland Pharma secures FDA approval for Latanoprost Solution
    Gland Pharma secures FDA approval for Latanoprost Solution

    03 Dec 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/gland-pharma-secures-us-fda-approval-for-latanoprost-ophthalmic-solution/

    EXPRESSPHARMA
    03 Dec 2024
    Share Share
    Gland Pharma Ltd spurts 1.67%, rises for third straight session
    Gland Pharma Ltd spurts 1.67%, rises for third straight session

    03 Dec 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/gland-pharma-ltd-spurts-1-67-rises-for-third-straight-session-124120300466_1.html

    BUSINESS STD
    03 Dec 2024
    Share Share
    Gland Pharma Share Up 3% On December 3; Details Here
    Gland Pharma Share Up 3% On December 3; Details Here

    03 Dec 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/news/here-s-why-gland-pharma-share-was-up-3-on-december-3-details-here-124120300369_1.html

    BUSINESS STD
    03 Dec 2024
    Share Share
    Volumes soar at Gl& Pharma Ltd counter
    Volumes soar at Gl& Pharma Ltd counter

    05 Nov 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/volumes-soar-at-gland-pharma-ltd-counter-124110500844_1.html

    BUSINESS STD
    05 Nov 2024
    Share Share

    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Atracurium Besylate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Atracurium Besylate

    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 Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21189

    Submission : 2007-12-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-272 - Rev 00

    Issue Date : 2015-12-18

    Type : Chemical

    Substance Number : 1970

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-03-05

    Valid Till : 2022-03-04

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Rocuronium Bromide

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

    Antibody Engineering
    Not Confirmed
    arrow

    Rocuronium Bromide

    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 : 2024-07-10

    Pay. Date : 2024-07-08

    DMF Number : 20833

    Submission : 2007-09-05

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2008-033 - Rev 01

    Issue Date : 2015-09-29

    Type : Chemical

    Substance Number : 1764

    Status : Withdrawn by Holder

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Argatroban

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

    Antibody Engineering
    Not Confirmed
    arrow

    Argatroban

    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 : 2013-07-12

    Pay. Date : 2013-03-26

    DMF Number : 25400

    Submission : 2011-10-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Betamethasone Acetate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Betamethasone Acetate

    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30716

    Submission : 2016-08-01

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Caspofungin

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

    Antibody Engineering
    Not Confirmed
    arrow

    Caspofungin

    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31893

    Submission : 2017-07-21

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Dexmedetomidine Hydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Dexmedetomidine 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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23232

    Submission : 2009-10-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Fresenius Kabi Korea Co., Ltd.

    Registration Date : 2021-03-12

    Registration Number : Su181-5-ND

    Manufacturer Name : Gland Pharm Limited

    Manufacturer Address : Sy.No.143 to 148, 150 & 151, Near Gandimaisamma Cross Roads, DP Pally, Dundigal post, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, Hyderabad - 500 043, Telangana, India

     VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Foscarnet Sodium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Foscarnet Sodium

    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 : 2016-01-08

    Pay. Date : 2015-09-28

    DMF Number : 29814

    Submission : 2015-09-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Indomethacin Sodium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Indomethacin Sodium

    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25401

    Submission : 2011-10-31

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Levothyroxine Sodium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Levothyroxine Sodium

    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 : 2015-09-25

    Pay. Date : 2015-08-17

    DMF Number : 29550

    Submission : 2015-07-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Paliperidone Palmitate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Paliperidone Palmitate

    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 : 2018-01-12

    Pay. Date : 2017-10-26

    DMF Number : 32041

    Submission : 2017-10-13

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2025-03-04

    Written Confirmation Number : WC-0427A3-4

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Excipients

    Click here to find the perfect excipient manufacturers by their capabilities

    Inspections and registrations

    Upload your audits for free, ask us

    FDA

    read-more
    read-more

    01

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-01-07

    GLAND PHARMA LIMITED

    City : Ranga Reddy, Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-01-07

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    02

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-09-07

    GLAND PHARMA LIMITED

    City : Ranga Reddy, Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-09-07

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    03

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-08-01

    GLAND PHARMA LIMITED

    City : Malur

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-08-01

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    04

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-08-05

    GLAND PHARMA LIMITED

    City : Visakhapatnam

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-08-05

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    05

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-03-17

    GLAND PHARMA LIMITED

    City : Ranga Reddy, Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-03-17

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    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 : 2017-02-03

    GLAND PHARMA LIMITED

    City : Ranga Reddy, Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-02-03

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    ABOUT THIS PAGE

    Contact GLAND PHARMA LIMITED and get a quotation

    GLAND PHARMA LIMITED is a supplier offers 70 products (APIs, Excipients or Intermediates).

    Find a price of Atracurium Besylate bulk with DMF, CEP offered by GLAND PHARMA LIMITED

    Find a price of Rocuronium Bromide bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Argatroban bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Betamethasone Acetate bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Caspofungin bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Dexmedetomidine Hydrochloride bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Doxycycline Hyclate bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Foscarnet Sodium bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Fosphenytoin Sodium bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Glatiramer Acetate bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Indomethacin Sodium bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Isoproterenol Hydrochloride bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Levothyroxine Sodium bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Neostigmine Methylsulfate bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Paliperidone Palmitate bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Plerixafor bulk with DMF, WC offered by GLAND PHARMA LIMITED

    Find a price of Cisatracurium Besylate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Dalteparin sodium bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Dexmedetomidine Hydrochloride bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Dexrazoxane bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Enoxaparin Sodium bulk with CEP offered by GLAND PHARMA LIMITED

    Find a price of Heparin Sodium bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Iron Dextran bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Iron Sucrose bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Regadenoson Monohydrate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Tigecycline bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Ziprasidone Mesylate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Acetazolamide bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Argatroban bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Aripiprazole bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Aripiprazole Lauroxil bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Atracurium Besylate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Chlorothiazide bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Copper Sulfate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Cysteamine Hydrochloride bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Dantrolene bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Diphenhydramine Hydrochloride bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Edaravone bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Epinephrine bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Ertapenem Sodium bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Erythromycin Lactobionate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Etomidate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Fluphenazine Decanoate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Fomepizole bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Fosaprepitant bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Fulvestrant bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Indomethacin Sodium bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Ketamine Hydrochloride bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Lacosamide bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Levocarnitine bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Linezolid bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Manganese Sulfate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Metaraminol Bitartrate bulk with WC offered by GLAND PHARMA LIMITED

    Find a price of Netarsudil Mesylate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Nicardipine Hydrochloride bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Procainamide Hydrochloride bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Protamine Sulfate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Selenious Acid bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Sodium Phenylacetate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Sugammadex Sodium bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Tirofiban bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Zinc Sulfate Heptahydrate bulk with DMF offered by GLAND PHARMA LIMITED

    Find a price of Argatroban Monohydrate bulk offered by GLAND PHARMA LIMITED

    Find a price of Dexmedetomidine Hydrochloride bulk offered by GLAND PHARMA LIMITED

    Find a price of Cangrelor bulk offered by GLAND PHARMA LIMITED

    Find a price of Isavuconazonium Sulfate bulk offered by GLAND PHARMA LIMITED

    Find a price of Oxytocin bulk offered by GLAND PHARMA LIMITED

    Find a price of Polymyxin B Sulfate bulk offered by GLAND PHARMA LIMITED

    Find a price of Sodium Phenyl Acetate bulk offered by GLAND PHARMA LIMITED

    Find a price of Sulfobutylether-β-Cydodextrin (SBECD) bulk offered by GLAND PHARMA LIMITED

    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search