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    Company profile for Divis Laboratories

    Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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    Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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    Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

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    Aspen API. More than just an API.

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    About

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 P...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

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    Divis Laboratories LimitedDivi Towers, 7-1-77/E/1/303,Dharam Karan Road, Ameer...
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    91 402 378 6322
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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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    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]
    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. 
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    Impressions: 421

    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
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    NEWS #PharmaBuzz

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    Divi's exits Nifty and gets 'buy' recommendation with highest target
    Divi's exits Nifty and gets 'buy' recommendation with highest target

    09 Oct 2024

    // CNBCTV18

    https://www.cnbctv18.com/market/divis-labs-exits-the-nifty-and-gets-a-buy-recommendation-with-its-highest-target-19489678.htm

    CNBCTV18
    09 Oct 2024
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    Divis Laboratories reports Q1 FY25 consolidated PAT at Rs. 430 Cr
    Divis Laboratories reports Q1 FY25 consolidated PAT at Rs. 430 Cr

    05 Aug 2024

    // ECONOMICSTIMES

    https://www.indianpharmapost.com/news/divis-laboratories-reports-q1-fy25-consolidated-pat-at-rs-430-cr-15974

    ECONOMICSTIMES
    05 Aug 2024
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    Granules India's Q1 profit nearly triples on strong demand
    Granules India's Q1 profit nearly triples on strong demand

    30 Jul 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/granules-indias-q1-profit-nearly-triples-strong-demand-2024-07-30/

    REUTERS
    30 Jul 2024
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    U.S. FDA Inspects Divi's Labs Facility In Visakhapatnam
    U.S. FDA Inspects Divi's Labs Facility In Visakhapatnam

    19 Jul 2024

    // NDTV PROFIT

    https://www.ndtvprofit.com/business/us-fda-inspects-divis-labs-facility-in-visakhapatnam

    NDTV PROFIT
    19 Jul 2024
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    Divi's Laboratories to expand capacity at an outlay of approx. Rs. 700 Cr
    Divi's Laboratories to expand capacity at an outlay of approx. Rs. 700 Cr

    25 Apr 2024

    // INDINPHARMAPOST

    https://www.indianpharmapost.com/news/divis-laboratories-to-expand-capacity-at-an-outlay-of-approx-rs-700-cr-15568

    INDINPHARMAPOST
    25 Apr 2024
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    Britannia most-loved, Divi’s Labs shunned by analysts in November
    Britannia most-loved, Divi’s Labs shunned by analysts in November

    02 Dec 2022

    // Shailaja Mohapatra MONEYCONTROL

    https://www.moneycontrol.com/news/business/britannia-most-loved-divis-labs-shunned-by-analysts-in-november-9633531.html

    Shailaja Mohapatra MONEYCONTROL
    02 Dec 2022
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    ALL APIs

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    01

    Dextromethorphan Hydrobromide

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

    Antibody Engineering
    Not Confirmed
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    Dextromethorphan Hydrobromide

    India

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

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    Antibody Engineering
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    • 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 : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-11-23

    DMF Number : 12356

    Submission : 1997-02-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-103 - Rev 06

    Issue Date : 2018-07-20

    Type : Chemical

    Substance Number : 20

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10567

    Registrant's Address : Divi Towers, 7-1-77/E/1/303, Dharam Karan Road, Ameerpet, Hyderabad-500 016, India

    Initial Date of Registration : 2005-09-09

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-16

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0031

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-003

    Start Marketing Date : 2002-01-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Johnson & Johnson Korea Sales Co., Ltd.

    Registration Date : 2023-06-26

    Registration Number : 20180727-209-J-32(3)

    Manufacturer Name : Divi's Laboratories Limited (Unit I)

    Manufacturer Address : Lingojigudem Village, Choutuppal Mandal Yadadri Bhuvanagiri District, Telangana 508252 India

     VMF Others AUDIT
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    02

    Levetiracetam

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

    Antibody Engineering
    Not Confirmed
    arrow

    Levetiracetam

    India

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

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    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 : 2012-12-26

    Pay. Date : 2012-11-23

    DMF Number : 16894

    Submission : 2003-10-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-079 - Rev 01

    Issue Date : 2020-12-04

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10067

    Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber ​​Hills, Gachibowli, Hyderabad-500 032, Telangana, India

    Initial Date of Registration : 2020-06-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-16

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0031

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-010

    Start Marketing Date : 2002-12-24

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Myungin Pharmaceutical Co., Ltd.

    Registration Date : 2022-05-31

    Registration Number : 20130205-183-I-233-02(3)

    Manufacturer Name : Divi's Laboratories Limited

    Manufacturer Address : Lingojigudem Village Choutuppal Mandal Yadadri-Bhuvanagiri District - 508 252, Telangana, INDIA

     VMF Others AUDIT
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    03

    Nabumetone

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

    Antibody Engineering
    Not Confirmed
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    Nabumetone

    India

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    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 : 2016-03-30

    Pay. Date : 2015-12-23

    DMF Number : 15364

    Submission : 2001-04-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-055 - Rev 06

    Issue Date : 2018-08-23

    Type : Chemical

    Substance Number : 1350

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10204

    Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers Cyber ​​Hills, Gachibowli Hyderabad - 500 032 Telangana, India.

    Initial Date of Registration : 2016-10-31

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-16

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0031

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-008

    Start Marketing Date : 2000-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Pavise Pharmaceutical Co., Ltd.

    Registration Date : 2019-12-23

    Registration Number : 20050831-2-C-58-02(12)

    Manufacturer Name : Divi's Laboratories Ltd.

    Manufacturer Address : Unit-1, Linggojigudem village Choutuppal Mandal Yadadri Bhuvanagiri District Telangana - 508252, India

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    04

    Carbidopa

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

    Antibody Engineering
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    Carbidopa

    India

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

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    Antibody Engineering
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-23

    Pay. Date : 2012-12-06

    DMF Number : 17846

    Submission : 2004-11-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-057 - Rev 05

    Issue Date : 2021-11-22

    Type : Chemical

    Substance Number : 755

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10125

    Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber ​​Hills, Gachibowli, Hyderabad-500 032, Telangana, India.

    Initial Date of Registration : 2013-07-02

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-06-17

    Valid Till : 2022-06-16

    Written Confirmation Number : WC-0030

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-014

    Start Marketing Date : 2004-03-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2020-03-12

    Registration Number : 20180816-211-J-254(2)

    Manufacturer Name : Divi's Laboratories Limited

    Manufacturer Address : Chippada Village Annavaram Post Bheemunipatnam Mandal Visakhapatnam District - 531 162 Andhra Pradesh, India

     VMF Others AUDIT
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    05

    Etilevodopa

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

    Antibody Engineering
    Not Confirmed
    arrow

    Etilevodopa

    India

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

    arrow
    Antibody Engineering
    Not Confirmed
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    • EDQM
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    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 : 2012-11-23

    Pay. Date : 2012-12-06

    DMF Number : 17874

    Submission : 2004-12-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-161 - Rev 04

    Issue Date : 2018-01-25

    Type : Chemical

    Substance Number : 38

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10235

    Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber ​​Hills, Gachibowli, Hyderabad-500 032, Telangana, India.

    Initial Date of Registration : 2015-09-24

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-06-17

    Valid Till : 2022-06-16

    Written Confirmation Number : WC-0030

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-013

    Start Marketing Date : 2004-03-17

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2020-03-12

    Registration Number : 20191021-209-J-458(2)

    Manufacturer Name : Divi's Laboratories Limited (Unit-2)

    Manufacturer Address : Chippada Village Annavaram Post Bheemunipatnam Mandal, Visakhapatnam District – 531162, Andhra Pradesh, India

     VMF Others AUDIT
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    06

    Lacosamide

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

    Antibody Engineering
    Not Confirmed
    arrow

    Lacosamide

    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 : 2021-10-11

    Pay. Date : 2021-07-19

    DMF Number : 35724

    Submission : 2021-03-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-437 - Rev 02

    Issue Date : 2023-07-27

    Type : Chemical

    Substance Number : 2992

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10100

    Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber ​​Hills, Gachibowli, Hyderabad-500 032, Telangana, India.

    Initial Date of Registration : 2024-07-17

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2021-04-01

    Valid Till : 2022-06-16

    Written Confirmation Number : WC-0030A3

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-062

    Start Marketing Date : 2020-09-21

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Parmarine Co., Ltd.

    Registration Date : 2021-08-20

    Registration Number : Number 97-1-ND

    Manufacturer Name : Divi's Laboratories Ltd.

    Manufacturer Address : Unit-2, 531162, Chippada Village, Annavaram, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh, INDIA

     VMF Others AUDIT
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    Market
    Place

    07

    Mesalazine

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

    Antibody Engineering
    Not Confirmed
    arrow

    Mesalazine

    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 : 2016-04-08

    Pay. Date : 2015-12-02

    DMF Number : 29998

    Submission : 2015-11-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-050 - Rev 01

    Issue Date : 2022-11-08

    Type : Chemical

    Substance Number : 1699

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10004

    Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber ​​Hills, Gachibowli, Hyderabad-500 032, Telangana, India.

    Initial Date of Registration : 2019-01-10

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-06-17

    Valid Till : 2022-06-16

    Written Confirmation Number : WC-0030

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-060

    Start Marketing Date : 2015-03-02

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Parmarine Co., Ltd.

    Registration Date : 2020-07-21

    Registration Number : 20200721-211-J-697

    Manufacturer Name : Divi`s Laboratories Limited

    Manufacturer Address : Chippada Village Annavaram Post Bheemunipatnam Mandal Visakhapatnam District – 531162 Andhra Pradesh India

     VMF Others AUDIT
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    Place

    08

    Valsartan

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

    Antibody Engineering
    Not Confirmed
    arrow

    Valsartan

    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 : 2013-03-28

    Pay. Date : 2013-03-13

    DMF Number : 24797

    Submission : 2011-03-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-338 - Rev 01

    Issue Date : 2020-05-25

    Type : Chemical

    Substance Number : 2423

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10044

    Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber ​​Hills, Gachibowli, Hyderabad-500 032, Telangana, India.

    Initial Date of Registration : 2020-04-14

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-06-17

    Valid Till : 2022-06-16

    Written Confirmation Number : WC-0030

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-050

    Start Marketing Date : 2010-01-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2021-05-04

    Registration Number : 20141014-135-H-249-40(2)

    Manufacturer Name : Divis Laboratories Limited

    Manufacturer Address : Unit-2, Annavaram (PO), Chippada (V), Bhimunipatnam (M), Visakhapatnam District, India

     VMF Others AUDIT
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    Place

    09

    Diltiazem Hydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Diltiazem Hydrochloride

    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 : 2013-03-15

    Pay. Date : 2013-02-27

    DMF Number : 15267

    Submission : 2001-01-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-156 - Rev 10

    Issue Date : 2020-02-24

    Type : Chemical

    Substance Number : 1004

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-16

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0031

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-005

    Start Marketing Date : 1997-10-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Parmarine Co., Ltd.

    Registration Date : 2020-08-06

    Registration Number : 20200806-209-J-505

    Manufacturer Name : Divi's Laboratories Limited (Unit-I)

    Manufacturer Address : Lingojigudem Village Choutuppal Mandal Yadadri Bhuvanagiri District Telangana - 508252 India

     VMF Others AUDIT
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    Place

    10

    Naproxen

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

    Antibody Engineering
    Not Confirmed
    arrow

    Naproxen

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-07-24

    Pay. Date : 2015-07-17

    DMF Number : 13866

    Submission : 1998-11-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-042 - Rev 08

    Issue Date : 2018-02-28

    Type : Chemical

    Substance Number : 731

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-16

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0031

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-001

    Start Marketing Date : 1999-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Parmarine Co., Ltd.

    Registration Date : 2023-11-30

    Registration Number : 20231130-143-I-666-13

    Manufacturer Name : Divi's Laboratories Ltd.

    Manufacturer Address : Unit-2, 531162, Chippada Village, Annavaram, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh, INDIA

     VMF Others AUDIT
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    USDMF

    read-more
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    01

    5-phenylhydantoin

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    02

    Bupropion Hydrochloride Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    03

    Capecitabine

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Capecitabine

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Divis Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-04-28

    Pay. Date : 2014-04-21

    DMF Number : 22157

    Submission : 2008-10-27

    Status : Active

    Type : II

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    04

    Carbidopa Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Carbidopa Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    Divis Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-23

    Pay. Date : 2012-12-06

    DMF Number : 17846

    Submission : 2004-11-20

    Status : Active

    Type : II

    blank

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    05

    Desloratadine

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    06

    Dextromethorphan Base Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    07

    Dextromethorphan Hydrobromide Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    Diltiazem Hydrochloride Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    09

    Fosphenytoin Sodium Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    10

    Gabapentin Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Gabapentin Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Divis Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-12-16

    Pay. Date : 2015-12-10

    DMF Number : 19000

    Submission : 2005-12-04

    Status : Active

    Type : II

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    LISTED APIs

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    Alectinib Hydrochloride

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    Market
    Place

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    01

    Alectinib Hydrochloride

    India
    Antibody Engineering
    Not Confirmed
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    Alectinib Hydrochloride

    India
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    Antibody Engineering
    Not Confirmed
    • fda
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

    About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big ...

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    Apixaban

    Product
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    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    02

    Apixaban

    India
    Antibody Engineering
    Not Confirmed
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    Apixaban

    India
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

    About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big ...

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    Astaxanthin

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    Place

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    03

    Astaxanthin

    India
    Antibody Engineering
    Not Confirmed
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    Astaxanthin

    India
    arrow
    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

    About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big ...

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    Beta Carotene

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    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    04

    Beta Carotene

    India
    Antibody Engineering
    Not Confirmed
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    Beta Carotene

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

    About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big ...

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    Brivaracetam

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    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    05

    Brivaracetam

    India
    Antibody Engineering
    Not Confirmed
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    Brivaracetam

    India
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

    About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big ...

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    Bupropion Hydrochloride

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    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    06

    Bupropion Hydrochloride

    India
    Antibody Engineering
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

    About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big ...

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    Canagliflozin

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    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    07

    Canagliflozin

    India
    Antibody Engineering
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    Canagliflozin

    India
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

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    Canthaxanthin

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    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    08

    Canthaxanthin

    India
    Antibody Engineering
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    India
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

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    Capecitabine

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    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    09

    Capecitabine

    India
    Antibody Engineering
    Not Confirmed
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    Capecitabine

    India
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

    About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big ...

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    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 man...
    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    10

    Carbidopa

    India
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    Divis Laboratories

    Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.

    About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big ...

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    Pharma, Lab & Chemical Expo
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    FDA Audited

    USA
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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-07-30

    Divis Laboratories

    City : Nalgonda District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-07-30

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    FDA Audited

    USA
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    FDA Audited

    USA
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-20

    Divis Laboratories

    City : Nalgonda District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-20

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    WHO-GMP

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    WHO GMP Certified

    Switzerland
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    Divis Laboratories

    Name and address of WHO GMP certified Manufacturer : DIVI'S LABORATORIES LIMITED UNIT-II, UNIT-II, Chippada Village, Visakhapatnam Dist.

    Country : India

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    WHO GMP Certified

    Switzerland
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    Divis Laboratories

    Name and address of WHO GMP certified Manufacturer : DIVI'S LABORATORIES LIMITED UNIT-II, Chippada Village, Annavaram (Post), Bheemunipatnam (M), Visakhapatnam Dist.

    Country : India

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    Contact Divis Laboratories and get a quotation

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