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    Company profile for Lupin Ltd

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    About

    Lupin Limited is a global pharmaceutical leader, based in Mumbai, India, with a strong presence in over 100 markets. It specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Known for its innovations, Lupin excels in therapeutic areas such as respiratory, cardiovascular, anti-diabetic, and more. With 15 advanced manufacturing facilities and 7 research ...
    Lupin Limited is a global pharmaceutical leader, based in Mumbai, India, with a strong presence in over 100 markets. It specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Known for its innovations, Lupin excels in therapeutic areas such as respiratory, cardiovascular, anti-diabetic, and more. With 15 advanced manufacturing facilities and 7 research centers worldwide, Lupin is driven by a dedicated workforce of over 22,000 professionals.

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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: 59

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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]

    ReelPharmaPartner in End-to-End API ManufacturingPartner in End-to-End API Manufacturing

    Partner in End-to-End API Manufacturing
    Partner in End-to-End API Manufacturing

    reelPartner in End-to-End API Manufacturing

    This PharmaReel showcases Coral Drugs, a global partner in end-to-end API manufacturing with more than 27 years of expertise. Supported by vertically integrated cGMP and ISO-compliant facilities, the company is backed by USFDA and EMA certifications, patents, and advanced micronization capabilities.

    Impressions: 3657

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

    CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

    The contract development and manufacturing organization (CDMO) sector has emerged as a key partner in new drug development. This was evident from the strategic investments, partnerships, and expansions witnessed in the third quarter (Q3) of 2025. Several CDMOs, such as Cohance Lifesciences, Fermion Oy, Axplora, AGC Pharma Chemicals invested in new projects. Others, including Veranova, Aenova, and Biosynth, expanded capacities, while Ofichem strengthened its footprint with the acquisition of Avivia BV. CDMOs like Fareva, Evonik, and Samsung Biologics forged strategic partnerships for growth. During Q3, the sector continued to adopt artificial intelligence (AI). This prompted the US Food and Drug Administration (FDA) to issue guidance that recognizes the increasing use of AI and data analytics in drug development.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Cohance, Veranova invest in bioconjugation suites in US; ChemExpress inks ADC deal Earlier this year, Indian drugmaker Suven Pharmaceuticals Limited merged with  leading CDMO Cohance Lifesciences Limited. The merged entity — Cohance Lifesciences — has invested US$ 10 million in a current Good Manufacturing Practice (cGMP) bioconjugation suite at its subsidiary NJ Bio in Princeton, New Jersey.  NJ Bio is executing a major program for an existing innovator client with multiple antibody-drug conjugate (ADC) candidates. Cohance also announced an INR 230 million (approximately US$ 2.58 million) investment in a cGMP oligonucleotide facility at its Hyderabad (India) site. Veranova’s Devens (Massachusetts) site successfully passed a routine FDA cGMP surveillance inspection with a “No Action Indicated” (NAI) classification. Earlier, the company had initiated a US$ 50 million investment to expand its ADC and bioconjugate capabilities at its Devens site. This includes a 9,000-square-foot facility expansion with a new process development lab, two additional cGMP suites, and state-of-the-art bioconjugation development and manufacturing capabilities. These initiatives strengthen the site’s highly potent API (HPAPI) and ADC development and manufacturing capabilities. Biosynth has expanded its Berlin facility with a new GMP bioconjugation suite. The expansion supports the company’s manufacturing capabilities in conjugate vaccines, conjugate drugs, activated polyethylene glycol (PEGs), and polymer-based drug delivery excipients. ChemExpress, Mabwell Bioscience, and Insilico Medicine have entered into a strategic partnership to jointly develop a large ADC compound library and advance next-generation ADC candidates. The collaboration combines Mabwell’s antibody and ADC technology, Insilico’s AI-powered drug design platform, and ChemExpress’s expertise in linker-payload chemistry. Together, they aim to build a complete, AI-driven ADC development model that accelerates discovery, optimization, and commercialization. This partnership is expected to enhance R&D efficiency and deliver safer, more effective cancer treatments.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Fermion, Axplora, Aenova increase API manufacturing capacities; ICE Pharma expands India facility Finnish CDMO Fermion Oy has launched a renovation project at its Hanko (Finland) production site to modernize its API manufacturing capabilities. This expansion is part of Fermion's broader strategy to increase production, enhance flexibility in the manufacturing of both existing and future pharmaceutical products, and enable potential contract manufacturing opportunities. German CDMO Axplora has announced a €6.5 million (approximately US$ 7.5 million) investment to expand its API manufacturing capacity at its Vizag site in India. This expansion aims to strengthen both production capabilities and supply chain resilience. India-based Aarti Pharmalabs has inaugurated the first phase of its greenfield manufacturing facility in Gujarat (India). This expansion aims to bolster Aarti's CDMO and contract manufacturing organization (CMO) services, targeting a revenue goal of INR 10 billion (approximately US$ 112 million). Snapdragon Chemistry, which was acquired by Cambrex in 2023, has expanded its Massachusetts facility to better support peptide drug development and manufacturing. With this upgrade, the company can now handle peptide projects from early development through full-scale manufacturing. Italy-headquartered ICE Pharma has expanded its Raichem facility in India. The new facility will enhance the production of ursodeoxycholic acid (UDCA), an API it derives from chicken bile. This expansion increases the site’s raw UDCA output by 120 metric tons annually. Spain-headquartered AGC Pharma Chemicals inaugurated a new advanced manufacturing plant in Barcelona, with an investment of €110 million (approximately US$ 128.3 million). The plant spans 7,500 square meters and integrates cutting-edge technologies to support the entire drug development lifecycle — from R&D to commercial manufacturing. This represents a 30 percent increase in the company’s production capacity and introduces a segment dedicated to HPAPIs. Germany-headquartered Aenova has launched a new hot melt extrusion platform at its Regensburg (Germany) site. This new equipment enables the production of advanced drug formulations, while handling all testing and quality checks in-house. The move strengthens Aenova’s capabilities in developing and manufacturing complex medications. US-based Cytovance Biologics has introduced in-house formulation development services, enhancing its role as a comprehensive partner for biologic drug developers. These services utilize quality-by-design principles to ensure speed, safety, and precision in current and future client programs.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available)  Ofichem acquires Avivia BV; Evonik, Samsung Biologics form strategic collaborations Europe-based CDMO Ofichem Group announced the acquisition of Avivia BV, a formulation development company in the Netherlands. This acquisition is part of Ofichem’s strategy to become a fully integrated provider of development solutions across both drug substance and drug product, with a focus on complex formulations. Ofichem has also acquired Meribel Pharma Solutions’ site in Uppsala (Sweden) to strengthen its support for biotech innovators and expand its presence in the Nordic region.  Simtra BioPharma Solutions has acquired a 65-acre property near its Bloomington, Indiana (US) facility, adding over 300,000 square feet of potential expansion space. With this site, Simtra now has the flexibility to rapidly expand in the US. German specialty chemicals company Evonik is partnering with German biotech Ethris to develop and commercialize a next-generation lipid nanoparticle (LNP) platform for delivering nucleic acid therapies. Evonik will assist in formulation using Ethris’ SNaP LNP technology. The LNP market alone is projected to grow to US$2.3 billion by 2032. Luxembourg-headquartered Fareva has partnered with Zhaoke Ophthalmology to expand its footprint in China’s pharma market. Zhaoke will act as Fareva’s go-to partner for customers seeking pharmaceutical manufacturing in China. Samsung Biologics has signed a 1.8 trillion won (US$ 1.3 billion) manufacturing agreement with an undisclosed US-based drugmaker. And UK-based eXmoor Pharma has partnered with Anthony Nolan to provide end-to-end services for cell therapy developers.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available)  Our view The global CDMO market, valued at around US$ 255 billion in 2025, is projected to grow to over US$ 465 billion by 2032. Significantly, about 60 percent of new drug approvals in the US and over 65 percent in Europe now involve CDMO support. The developments outlined above underscore the increasing role CDMOs are playing today in bringing about growth and innovation in the pharmaceutical industry.  
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    Impressions: 1722

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-veranova-chemexpress-invest-in-adc-facilities-cohance-to-set-up-oligonucleotide-facility-in-india

    #PharmaFlow by PHARMACOMPASS
    16 Oct 2025
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    NEWS #PharmaBuzz

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    Lupin Digital Health Introduces AI Cardiometabolic Platform
    Lupin Digital Health Introduces AI Cardiometabolic Platform

    30 Oct 2025

    // EXPRESSPHARMA

    https://www.expresspharma.in/lupin-digital-health-launches-ai-based-cardiometabolic-wellness-platform-vitalyfe/

    EXPRESSPHARMA
    30 Oct 2025
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    Lupin Inaugurates New Headquarters In Bridgewater, NJ
    Lupin Inaugurates New Headquarters In Bridgewater, NJ

    28 Oct 2025

    // PRESS RELEASE

    https://www.lupin.com/governor-murphy-and-local-leaders-attend-ribbon-cutting-ceremony-marking-the-inauguration-of-lupins-new-corporate-offices-in-bridgewater/

    PRESS RELEASE
    28 Oct 2025
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    Lupin Launches Authorized Generic Of Ravicti In US
    Lupin Launches Authorized Generic Of Ravicti In US

    24 Oct 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/lupin-launches-authorized-generic-of-ravicti-in-us-18066

    INDPHARMAPOST
    24 Oct 2025
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    Lupin Presents Phase 1 Data On LNP3693 At ESMO Congress 2025
    Lupin Presents Phase 1 Data On LNP3693 At ESMO Congress 2025

    13 Oct 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/lupin-announces-presentation-of-phase-1-data-on-lnp3693-sting-agonist-at-the-esmo-congress-2025-302580735.html

    PR NEWSWIRE
    13 Oct 2025
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    Lupin To Lay Out $250M For New Fla. Manufacturing Facility
    Lupin To Lay Out $250M For New Fla. Manufacturing Facility

    10 Oct 2025

    // PRESS RELEASE

    https://www.lupin.com/lupin-announces-plans-to-build-a-new-state-of-the-art-manufacturing-facility-in-coral-springs-florida/

    PRESS RELEASE
    10 Oct 2025
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    Lupin Launches Partnership to Expand Long-Acting Injectables
    Lupin Launches Partnership to Expand Long-Acting Injectables

    09 Oct 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/lupin-unveils-strategic-partnership-program-to-expand-reach-of-its-long-acting-injectable-platform-302579569.html

    PR NEWSWIRE
    09 Oct 2025
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    ALL APIs

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    read-moreClick the button for full data set

    01

    Ethambutol Dihydrochloride

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Ethambutol Dihydrochloride

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20404

    Submission : 2007-03-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-019 - Rev 06

    Issue Date : 2021-03-18

    Type : Chemical

    Substance Number : 553

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10019

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2013-02-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-07

    Valid Till : 2028-07-31

    Written Confirmation Number : WC-0048

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

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    #PipelineProspector

    Market
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    02

    Levetiracetam

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Levetiracetam

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19080

    Submission : 2005-12-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-242 - Rev 03

    Issue Date : 2024-03-22

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10101

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2020-08-18

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-16

    Written Confirmation Number : WC-0049

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Wonpung Pharmaceutical Co., Ltd.

    Registration Date : 2025-04-24

    Registration Number : 20171024-183-I-521-28(1)

    Manufacturer Name : Lupin Limited

    Manufacturer Address : T-142, Tarapur, Via Boisar, Thane 401506 Maharashtra State, India

     VMF Others AUDIT
    blank

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    Market
    Place

    03

    Lisinopril

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Lisinopril

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15098

    Submission : 2000-10-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-311 - Rev 04

    Issue Date : 2019-09-27

    Type : Chemical

    Substance Number : 1120

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10069

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2019-09-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-10-08

    Valid Till : 2028-07-04

    Written Confirmation Number : WC-0202

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57297-511

    Start Marketing Date : 2000-10-18

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hyundai Pharmaceutical Co., Ltd.

    Registration Date : 2025-03-11

    Registration Number : 20250311-209-J-1809

    Manufacturer Name : Lupin Limited

    Manufacturer Address : Unit-2, 198-202, New Industrial Area no. 2, District Raisen Mandideep, Madhya Pradesh 462046, India

     VMF Others AUDIT
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    04

    Amlodipine Besylate

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Amlodipine Besylate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-27

    Pay. Date : 2014-01-21

    DMF Number : 18839

    Submission : 2005-10-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-031 - Rev 02

    Issue Date : 2017-05-05

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10116

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2010-03-25

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
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    Stock Recap
    #PipelineProspector

    Market
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    05

    Duloxetine Hydrochloride

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Duloxetine Hydrochloride

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21524

    Submission : 2008-04-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-144 - Rev 00

    Issue Date : 2022-03-17

    Type : Chemical

    Substance Number : 2594

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10025

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2020-02-06

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Quetiapine Hemifumarate

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Quetiapine Hemifumarate

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21513

    Submission : 2008-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-221 - Rev 01

    Issue Date : 2024-10-21

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10055

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2011-04-21

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    07

    Simvastatin

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

    AIChE Annual Meeting
    Not Confirmed
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    Simvastatin

    India

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

    arrow
    AIChE Annual Meeting
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-17

    Pay. Date : 2017-02-28

    DMF Number : 17934

    Submission : 2004-12-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-100 - Rev 06

    Issue Date : 2020-08-14

    Type : Chemical

    Substance Number : 1563

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10075

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2021-05-10

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Masung LS Co., Ltd.

    Registration Date : 2012-06-29

    Registration Number : 20060707-29-B-237-17(4)

    Manufacturer Name : Lupin Limited

    Manufacturer Address : T-142, MIDC, Tarapur, Via Boisar, Maharashtra 401 506, India

     VMF Others AUDIT
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    08

    Zolpidem Tartrate

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Zolpidem Tartrate

    India

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

    arrow
    AIChE Annual Meeting
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18430

    Submission : 2005-06-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-032 - Rev 01

    Issue Date : 2016-09-13

    Type : Chemical

    Substance Number : 1280

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10220

    Registrant's Address : 159, CST Road, Kalina, Santacruz (East) Mumbai-400 098, INDIA

    Initial Date of Registration : 2010-08-16

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    09

    Abacavir Sulfate

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Abacavir Sulfate

    India

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

    arrow
    AIChE Annual Meeting
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    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-27

    Pay. Date : 2012-11-20

    DMF Number : 23618

    Submission : 2010-04-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-342 - Rev 00

    Issue Date : 2022-02-24

    Type : Chemical

    Substance Number : 2589

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10171

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2017-08-28

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    10

    Cefaclor

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

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Cefaclor

    India

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

    arrow
    AIChE Annual Meeting
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12086

    Submission : 1996-08-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-359 - Rev 05

    Issue Date : 2018-06-12

    Type : Chemical

    Substance Number : 986

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-10-08

    Valid Till : 2028-07-04

    Written Confirmation Number : WC-0202

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Big Farms Co., Ltd.

    Registration Date : 2019-08-29

    Registration Number : 20050831-20-A-21-05(22)

    Manufacturer Name : Lupin Ltd.

    Manufacturer Address : Unit-1, 198-202, New Industrial area No.2 Dist. - Raisen Mandideep Madhya Pradesh 462046, India

     VMF Others AUDIT
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