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    Company profile for Divis Laboratories

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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

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    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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    About

    Divis 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 Pi...
    Divis 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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    1-72/23(P)/DIVIS/303, Divi Towers, Cyber Hills, Gachibowli, Hyderabad, Telanga...
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Over 500 million syringes of our hyaluronic acid have been safely used worldwide”

    mic“Over 500 million syringes of our hyaluronic acid have been safely used worldwide”

    This week, SpeakPharma interviews Marie-Armelle Floc’h, Chief of Quality and Regulatory Affairs at HTL Biotechnology, a global leader in the development and the manufacturing of pharmaceutical-grade biopolymers headquartered in Javené, Brittany (France). Since 1992, HTL has pioneered the production of hyaluronic acid (HA) through proprietary biofermentation, achieving unmatched purity and consistency for applications in ophthalmology, dermatology and rheumatology. Floc’h highlights how HTL Biotechnology’s compelling portfolio of pharmaceutical-grade biopolymers is built on uncompromising quality standards. These standards have enabled the company to supply biopolymers for over 30 years without a single batch recall, firmly establishing its reputation for reliability and excellence. She also discusses the inauguration of HTL Biotechnology’s new sterile hyaluronic acid production unit — a major milestone that reinforces the company’s leadership in biopolymer manufacturing and enables the development of innovative formulations combining hyaluronic acid with thermo-sensitive active ingredients. This new capability opens the door to advanced biomedical applications where safety, stability and efficacy must be preserved without compromising the integrity of delicate molecules and which requires the highest quality standards. What distinguishes HTL Biotechnology’s biopolymer platforms in the market today? HTL Biotechnology has built its reputation on delivering pharmaceutical‑grade biopolymers (hyaluronic acid, polynucleotides and recombinant collagen) with unmatched purity and consistency. Since its founding in 1992, the company has focused on premium quality positioning. With more than 30 years of experience, HTL Biotechnology guarantees pharmaceutical-grade biopolymers of exceptional purity and exemplary consistency to our clients. We have had no batch recalls in 30 years, a record that underlines the rigor and reliability embedded in our processes. This was made possible by our fully-integrated site in France, where R&D laboratories, GMP manufacturing, quality control, and regulatory expertise are brought together under one roof. Such integration allows us to support our clients seamlessly throughout their product development journey, from early innovation through to global commercialization.Also, the inauguration of our new sterile hyaluronic acid production unit expands the possibilities for our HA to be used in advanced formulations with thermo-sensitive active ingredients, while upholding the uncompromising quality that defines HTL Biotechnology.Our operations are guided by internationally recognized standards, including ISO 13485 certification, which ensures the quality and safety required by medical device manufacturers worldwide.In addition, our Halal certification provides our customers with a significant advantage in accessing and expanding into markets where these requirements are essential for commercialization.Beyond certifications, our commitment to supporting global growth is reflected in the Drug Master Files we maintain across five continents, enabling our clients to accelerate product registration and bring innovative therapies to markets across the world more efficiently. By combining craftsmanship with pharmaceutical rigor, supported by state-of-the-art equipment and advanced bio-production methods, we ensure that every batch produced not only meets the strictest standards, but also delivers the reliability and consistency needed across the entire healthcare ecosystem. HIGHLIGHTS// Biopolymers with unmatched purity/record of no batch recalls/integrated facility in France/operations guided by global standards/new sterile HA unit for advanced formulations  Navigating the complex and evolving regulatory frameworks across global markets can be challenging for healthcare companies. Can you tell us more about how HTL Biotechnology supports its partners in this area? Regulatory support is part of our core premium services offer. We provide pharmaceutical regulatory support to ensure products meet the necessary compliance standards, so our partners can focus on their growth. Our dedicated regulatory professionals bring global and regional expertise, with a team specifically supporting customers in Asia. We offer personalized assistance adapted to their products and to the compliance standards of the target market. This includes personalized case-management support for regulatory file submissions with the concerned health authorities to minimize risks of refusal or delay, with the aim of achieving approval quickly and smoothly.Our offer for regulatory support continues beyond approval. We continuously monitor updates to regulations and provide post-commercialization support to our partners to help them manage any necessary regulatory updates.HIGHLIGHTS// Regulatory support offered as premium service/global and regional expertise/personalized case management for faster approvals/continuous regulatory support  How does HTL Biotechnology integrate sustainability and corporate responsibility into its operations? Sustainability is embedded in HTL Biotechnology’s strategic vision and day-to-day operations. In 2024, the company renewed its commitment to environmental responsibility by reinforcing its corporate social responsibility (CSR) roadmap. Tangible progress was made across multiple fronts: a 27 percent reduction in greenhouse gas emissions per kilogram of HA produced between 2021 and 2024, and a 34 percent reduction in water consumption per kilogram of HA since 2020. In 2024, we renewed the ISO 14001:2015 certification for its environmental management system, reflecting rigorous audit protocols and continual improvement cycles. All employees have been trained in the ISO 14001-certified environmental management system, and 78 percent of critical suppliers have signed HTL Biotechnology’s Responsible Purchasing Charter.These results reflect HTL Biotechnology’s structured and proactive approach to reducing its environmental footprint while maintaining the highest standards of quality and compliance.HIGHLIGHTS// Sustainability embedded in strategic vision/strong CSR roadmap with measurable progress/reduction in greenhouse gas emissions/responsible sourcing 

    Impressions: 889

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    https://www.pharmacompass.com/speak-pharma/over-500-million-syringes-of-our-hyaluronic-acid-have-been-safely-used-worldwide

    PharmaCompass
    04 Nov 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaA Full-Service API CompanyA Full-Service API Company

    A Full-Service API Company
    A Full-Service API Company

    reelA Full-Service API Company

    This PharmaReel showcases ChemWerth, a full-service generic API company with over 40 years of experience, offering cGMP-quality APIs through 30+ manufacturing partners across the US, EU, India, and China, backed by 550+ global filings, and expertise in new product development, compliance, and logistics.

    Impressions: 1971

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 
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    Impressions: 556

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

    #PharmaFlow by PHARMACOMPASS
    13 Nov 2025
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    NEWS #PharmaBuzz

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    Divis Laboratories Reports Q1 FY26 PAT of Rs. 545 Cr
    Divis Laboratories Reports Q1 FY26 PAT of Rs. 545 Cr

    10 Aug 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/divis-laboratories-posts-consolidated-q1-fy26-pat-of-rs-545-cr-17572

    INDPHARMAPOST
    10 Aug 2025
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    Divi's Labs Signs Deal with global pharma for manufacturing
    Divi's Labs Signs Deal with global pharma for manufacturing

    26 May 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/divis-laboratories-inks-manufacturing-and-supply-agreement-with-global-pharma-company-17205

    INDPHARMAPOST
    26 May 2025
    Share Share
    Divi's Laboratories sees strong growth, valuation limits upside
    Divi's Laboratories sees strong growth, valuation limits upside

    19 May 2025

    // BUSINESS STD

    https://www.business-standard.com/markets/news/strong-growth-prospects-ahead-for-divi-s-laboratories-125051901248_1.html

    BUSINESS STD
    19 May 2025
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    Divi's Lab inks supply pact with global pharmaceutical entity
    Divi's Lab inks supply pact with global pharmaceutical entity

    18 Apr 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/divis-lab-inks-supply-pact-with-global-pharmaceutical-entity/articleshow/120402931.cms

    ECONOMICTIMES
    18 Apr 2025
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    India's Divi's Labs beats Q3 profit estimates on strong API demand
    India's Divi's Labs beats Q3 profit estimates on strong API demand

    03 Feb 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/indias-divis-labs-beats-q3-profit-estimates-strong-api-demand-shares-rise-2025-02-03/

    REUTERS
    03 Feb 2025
    Share Share
    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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    ALL APIs

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    01

    Carbidopa

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

    Neuroscience
    Not Confirmed
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    Carbidopa

    India

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

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    Neuroscience
    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 : 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-WCarrow-down
    ✖

    Date of Issue : 2025-06-27

    Valid Till : 2028-06-16

    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 : 2026-12-31

    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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    02

    Dextromethorphan Hydrobromide

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

    Neuroscience
    Not Confirmed
    arrow

    Dextromethorphan Hydrobromide

    India

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

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    Neuroscience
    Not Confirmed
    • fda
    • EDQM
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    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 : 2025-06-13

    Valid Till : 2028-06-16

    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 : 2026-12-31

    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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    03

    Diltiazem Hydrochloride

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

    Neuroscience
    Not Confirmed
    arrow

    Diltiazem Hydrochloride

    India

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

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    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 arrow-down
    ✖

    Registration Number : 307MF10081

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

    Initial Date of Registration : 2025-07-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-06-13

    Valid Till : 2028-06-16

    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmaline 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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    04

    Lacosamide

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

    Neuroscience
    Not Confirmed
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    Lacosamide

    India

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

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    • EDQM
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    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-WCarrow-down
    ✖

    Date of Issue : 2025-06-27

    Valid Till : 2028-06-16

    Written Confirmation Number : WC-0030

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-062

    Start Marketing Date : 2020-09-21

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmaline Co., Ltd.

    Registration Date : 2021-08-20

    Registration Number : Su97-1-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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    05

    Levetiracetam

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

    Neuroscience
    Not Confirmed
    arrow

    Levetiracetam

    India

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

    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 : 2025-06-13

    Valid Till : 2028-06-16

    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 : 2026-12-31

    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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    06

    Mesalazine

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

    Neuroscience
    Not Confirmed
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    Mesalazine

    India

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

    arrow
    Neuroscience
    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-WCarrow-down
    ✖

    Date of Issue : 2025-06-13

    Valid Till : 2028-06-16

    Written Confirmation Number : WC-0031

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-064

    Start Marketing Date : 2022-09-19

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmaline 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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    07

    Nabumetone

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

    Neuroscience
    Not Confirmed
    arrow

    Nabumetone

    India

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

    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 : 2025-06-13

    Valid Till : 2028-06-16

    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 : 2026-12-31

    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

     VMF Others AUDIT
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    08

    Valsartan

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

    Neuroscience
    Not Confirmed
    arrow

    Valsartan

    India

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

    arrow
    Neuroscience
    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-WCarrow-down
    ✖

    Date of Issue : 2025-06-27

    Valid Till : 2028-06-16

    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Co., 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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    09

    Naproxen

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

    Neuroscience
    Not Confirmed
    arrow

    Naproxen

    India

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

    arrow
    Neuroscience
    Not Confirmed
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    • EDQM
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    USDMF arrow-down
    ✖

    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 : 2025-06-13

    Valid Till : 2028-06-16

    Written Confirmation Number : WC-0031

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-029

    Start Marketing Date : 2006-08-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmaline 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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    Market
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    10

    Naproxen Sodium

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

    Neuroscience
    Not Confirmed
    arrow

    Naproxen Sodium

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-07

    Pay. Date : 2013-07-26

    DMF Number : 13867

    Submission : 1998-11-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-110 - Rev 04

    Issue Date : 2021-10-21

    Type : Chemical

    Substance Number : 1702

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-06-13

    Valid Till : 2028-06-16

    Written Confirmation Number : WC-0031

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62331-030

    Start Marketing Date : 2006-08-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Myungin Pharmaceutical Co., Ltd.

    Registration Date : 2019-02-22

    Registration Number : 20130131-143-I-232-05(8)

    Manufacturer Name : Divi's Laboratories Limited

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

     VMF Others AUDIT
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    Contact Divis Laboratories and get a quotation

    Divis Laboratories is a supplier offers 103 products (APIs, Excipients or Intermediates).

    Find a price of Carbidopa bulk with DMF, CEP, JDMF, WC offered by Divis Laboratories

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