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    Company profile for Hetero Drugs

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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    Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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    Inke S.A: APIs manufacturing plant.

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    Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    EVENTS

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    ACTIVE PHARMA INGREDIENTS

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    FINISHED DOSAGE FORMULATIONS

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    About

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertica...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

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    CONTACT DETAILS

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    7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “We are building capabilities to stay ahead of the curve, and align with future needs of global healthcare”

    mic“We are building capabilities to stay ahead of the curve, and align with future needs of global healthcare”

    This week, SpeakPharma interviews Girish Chovatia, Chairman and Managing Director of Ami Lifesciences. Since its inception in 2006, Ami Lifesciences has emerged as one of the fastest-growing API manufacturers from India, delivering high-quality active pharmaceutical ingredients (APIs) to global partners across more than 60 countries. With a portfolio of 80+ APIs and strong regulatory accreditations, including those from the US Food and Drug Administration (FDA), European Directorate for the Quality of Medicines & HealthCare (EDQM), and the Pharmaceuticals and Medical Devices Agency (PMDA), the company has built a reputation for innovation, reliability, and customer-centricity.Ami Lifesciences’ ability to combine chemistry expertise with forward-looking strategies such as backward integration, custom synthesis, and a growing focus on platform technologies for next-generation therapeutics sets it apart. The company’s state-of-the-art infrastructure, emphasis on regulatory compliance, and quality culture built from the development stage enable it to serve as a trusted partner to leading pharmaceutical companies worldwide.In this interview, Chovatia shares key milestones in Ami Lifesciences’ growth journey, its approach to sustainability and innovation, and vision for expanding into new therapeutic areas and technologies to strengthen their global presence.Ami Lifesciences has grown rapidly since it began API operations in 2006. What have been the key strategic decisions or turning points that have fueled this growth?When we started API operations in 2006, we knew we were entering a highly competitive, globalized market. The key turning points in our journey were rooted in making bold but carefully thought-out strategic decisions. The first was building a quality-first culture from day one. We invested early in strong regulatory systems, which allowed us to secure approvals from agencies like FDA, EDQM and, PMDA, opening global markets.Another major factor was our focus on complex chemistry and high-barrier molecules. Instead of competing only in crowded, generic APIs, we decided to differentiate ourselves by developing technically challenging products where our chemistry expertise could shine.We also expanded our global footprint quickly, entering over 60 countries with a diverse product portfolio. Partnerships with leading pharmaceutical companies gave us both credibility and growth momentum. Each milestone—from our first CEP approval to our first FDA clearance—strengthened our foundation.Most importantly, we built a team that believes in long-term value creation, not shortcuts. That culture of quality, innovation, and customer trust continues to fuel our growth.HIGHLIGHTS// Building quality-first culture/focus on complex chemistry/expanding global footprint/belief in long-term value creationWith 80 APIs and a presence in more than 60 countries, how does Ami Lifesciences ensure regulatory compliance and maintain quality standards across such a diverse global footprint?For us, regulatory compliance is not just a requirement—it is the backbone of our credibility. We’ve built a quality culture that starts from the development stage itself. Our dedicated DQA (Development Quality Assurance) and DRA (Development Regulatory Affairs) teams are involved right from early R&D, ensuring that every molecule is designed with regulatory expectations in mind.All our facilities operate under stringent cGMP (current good manufacturing practices) conditions and are routinely audited by leading authorities, including the FDA, EDQM, PMDA, and multiple global partners. We have built robust systems for documentation, training, and monitoring that keep compliance non-negotiable.Equally important is the mindset—we train our teams to think “compliance-first” in every activity, big or small. Whether it’s a lab scientist, a production engineer, or a QA associate, everyone knows that quality and compliance are paramount.This integration of systems, people and, culture ensures that no matter which market we serve—be it the US, Europe, Japan, or emerging economies—our partners receive products of consistently high standards.HIGHLIGHTS// Compliance backbone of credibility/stringent cGMP conditions/‘compliance-first mindset’/consistency in high standardsHow does Ami Lifesciences’ backward integration across key molecules strengthen cost competitiveness and supply chain assurance for its global clients?Backward integration has been a conscious strategy for us. In today’s environment, customers not only seek high-quality APIs but also security of supply and cost competitiveness. By investing in in-house development and manufacture of key intermediates, we reduce dependency on external vendors and volatile supply chains.This gives us multiple advantages. First, it brings down costs and improves pricing stability, making us a more competitive partner globally. Second, it gives us greater control over timelines—something our clients value tremendously, especially in regulated markets. And third, it ensures resilience; even during global disruptions. We can assure our partners of uninterrupted supply.In a market where reliability is as critical as cost, our backward integration strategy has become a cornerstone of trust and long-term partnerships.HIGHLIGHTS// Backward integration strategy/focus on in-house development/lower costs/control over timelines global footprint/resilience during disruptionsHow is Ami Lifesciences leveraging R&D capabilities and custom synthesis to drive innovation in various therapeutic areas? Our R&D strength has always been at the core of our differentiation. We have over 150 scientists dedicated to developing APIs across complex therapeutic areas such as cardiovascular, anti-diabetic, and central nervous system (CNS) disorders.What sets us apart is our ability to go beyond standard generics. We focus on process innovation—green chemistry, enzymatic applications, and continuous improvement—to make synthesis routes not only cost-effective but also environmentally responsible.Custom synthesis is another pillar. Many of our global partners approach us for tailor-made solutions—whether it’s a new intermediate, a complex chiral molecule, or a high-barrier API. Our flexible R&D infrastructure allows us to design and scale processes efficiently, from grams in the lab to multi-ton manufacturing.By marrying strong chemistry capabilities with customer collaboration, we’ve positioned ourselves as more than a manufacturer—we’re an innovation partner contributing to faster, safer, and more affordable therapies worldwide.HIGHLIGHTS// Strong R&D capabilities/complex therapeutic expertise/green chemistry/custom synthesis solutions/innovation partner for safer therapiesWhat are the next big milestones Ami Lifesciences is targeting in terms of product development and global expansion?Looking ahead, we see the future of Ami Lifesciences in both depth and diversification. On the product side, we are expanding into next-generation therapeutics—with focus areas including oncology APIs, ADC payloads and linkers, short peptides, and select biotechnology platforms. These are high-value, high-science areas where our chemistry expertise and process innovation can create significant impact.We are also investing in platform technologies that can be applied across multiple therapeutic areas, giving us a strategic edge in next-gen molecules.From a global perspective, our milestones include broadening our presence in regulated markets like the US, Europe, and Japan, while simultaneously strengthening our reach in fast-growing markets across Asia, LATAM, and Africa.Our guiding principle is to stay ahead of the curve—building a portfolio and capabilities that align with where global healthcare is heading, not just where it is today.HIGHLIGHTS// Expanding to new-gen therapeutics/investing in platform technologies/broadening presence in regulated markets/staying ahead of the curveCould you elaborate on Ami Lifesciences’ ESG initiatives and how they are integrated into your manufacturing and business strategy?Sustainability is no longer optional—it’s integral to how we do business. At Ami, we’ve made ESG a central pillar of our growth strategy.On the environmental front, we are pioneers in integrating green chemistry and enzymatic applications into our processes. By leveraging biocatalysis, we reduce reliance on harsh chemicals, improve atom economy, and minimize energy usage. Our plants are designed for solvent recovery, water recycling, and energy efficiency, with strong commitments to waste reduction and zero liquid discharge.Socially, we invest heavily in our people and communities. From training and development to ensuring a safe workplace, we believe our people are our greatest asset. Beyond our facilities, we engage in education, healthcare, and environmental initiatives that uplift surrounding communities.On governance, we run with transparency, accountability, and ethics at the forefront. Our systems ensure compliance not just with laws but with global best practices in corporate responsibility.This holistic ESG framework ensures that as we grow, we do so responsibly create value for customers, employees, communities, and the environment alike.HIGHLIGHTS// ESG central to growth strategy/energy and resource efficiency/waste reduction and zero liquid discharge/holistic responsible growthHow does Ami Lifesciences’ manufacturing infrastructure enhance scalability and quality for its clients?Our manufacturing infrastructure is built for both flexibility and scale. Our Karakhadi facility (in Gujarat) is approved by leading agencies such as FDA, EDQM, ANVISA (Brazilian Health Regulatory Agency), NMPA (National Medical Products Administration of China) and KMFDS (Korean Ministry of Food and Drug Safety). Our products are filed in many other regulatory agencies like PMDA of Japan, NMPA of China, Therapeutic Goods Administration of Australia and Health Canada; giving our partners complete confidence in compliance and quality.The facility has multi-purpose production blocks, allowing us to handle diverse chemistries and scale projects seamlessly—from grams in the lab to multi-ton commercial quantities. This scalability is a key advantage for customers looking for a partner that can support them across the product lifecycle.We further strengthen supply reliability through backward integration of intermediates, which secures both cost efficiency and supply assurance.What makes us unique is the way we integrate quality and sustainability into manufacturing. By embedding quality from the development stage and incorporating green chemistry and enzymatic processes, we ensure that our output is not only reliable and compliant but also environmentally responsible.This combination of regulatory strength, scalability, and sustainable practices makes Ami a trusted long-term partner for leading pharma companies worldwide.HIGHLIGHTS// Flexible, scalable manufacturing infrastructure/facility approved by leading regulators/multi-purpose production blocks/quality, sustainability integrated into manufacturing 

    Impressions: 85

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    https://www.pharmacompass.com/speak-pharma/we-are-building-capabilities-to-stay-ahead-of-the-curve-and-align-with-future-needs-of-global-healthcare

    PharmaCompass
    13 Oct 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: 2174

    read-more

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    Precise particle size control has become the cornerstone of modern pharmaceutical manufacturing. With highly potent active pharmaceutical ingredients (HPAPIs) and complex formulations driving unprecedented demand, micronization technology is no longer optional — it's critical. The market reflects this urgency. The global API micronization market will jump from US$ 2.47 billion in 2024 to US$ 3.68 billion by 2030 — a 49 percent surge driven by a robust 6.84 percent CAGR. What's powering this growth? Strategic innovation by industry leaders. Companies like Munit SA, Lonza, Catalent, Veranova, EUROAPI, AGC Pharma Chemicals, Hovione and Coral Drugs aren't just participating — they're defining the future of pharmaceutical particle engineering. The Micronization Landscape: How leading companies are advancing pharmaceutical particle engineering The API micronization space is being shaped by companies with specialized expertise. Munit’s proprietary fluid jet milling technology brings particle sizes down to the 1-micron level — critical for inhalation therapies. In addition, this technology enables precise control over particle size distribution without mechanical impact, making it ideal for heat-sensitive and high-potency APIs. With decades of hands-on experience, Munit ensures batch-to-batch consistency, scalability from R&D to commercial volumes, and full compliance with GMP standards.  Munit offers high-containment isolators — including glove boxes for R&D and half-suit isolators for larger batches — with industry-leading containment levels, limiting airborne drug exposure to as low as 0.025 micrograms per cubic meter. This makes it particularly well-suited for handling highly potent or sensitive compounds, exceeding the capabilities of other commercial-scale players like Catalent, who typically achieve containment levels of 0.05 micrograms per cubic meter or higher. EUROAPI has taken a broad particle engineering approach, offering both micronization and spray drying across multiple dosage routes — oral, inhaled, and parenteral. AGC Pharma Chemical leverages spray drying and amorphous solid dispersion technologies across small molecules, peptides, ADCs, and oligonucleotides, exemplifying the evolving intersection of particle engineering and modern drug delivery innovation. Coral Drugs delivers cutting-edge technology and customization capabilities that tailor particle sizes to specific client requirements across tablets, injectables, and topicals. This dynamic competitive landscape continues to evolve as companies expand capabilities and form strategic partnerships. This year, Dec Group announced the launch of their cutting-edge Micronization Suite, now operational in Brick, New Jersey, while Lonza joined the Centre for Continuous Manufacturing and Advanced Crystallisation, an international research hub, to develop innovative continuous processing and crystallization solutions. Selecting the right micronization partner: Key success factors In a pharmaceutical landscape increasingly defined by complexity, precision, and speed-to-market, the choice of a micronization partner can significantly influence a drug’s success. Among the players in this space, Munit SA has emerged as a trusted and strategic ally for pharmaceutical companies worldwide. But what exactly sets Munit apart in the micronization market? To begin with, Munit SA brings over 60 years of experience in particle size engineering. This legacy is not just a number; it reflects decades of accumulated knowledge, process refinement, and a deep understanding of how particle size impacts drug performance. In an industry where even minor deviations can compromise efficacy or safety, this level of experience is invaluable. It has delivered over 500 successful micronization projects to more than 150 customers globally. At its core, Munit SA is laser-focused on micronization and milling — not as ancillary services, but as its primary mission. Their facilities are designed for processing high-potency APIs, cytotoxic and cytostatic compounds, non-beta-lactam antibiotics, steroids, and controlled substances under stringent containment protocols. The company also handles inhalation products, peptides, biological drugs, generics, and R&D compounds. Whether it's micronization for ophthalmic formulations, transdermal or oral products, Munit offers a tailored approach. It stands as a world-leading provider of micronization services in inhalation powders with particle sizes of 1-5 microns and specialized oncology applications for small molecules. In an increasingly complex global landscape, Munit SA addresses supply chain challenges through its dual-site operational model, with facilities in Switzerland (Jetpharma SA) and Italy (Microchem S.r.l). This strategic setup mitigates risks from regulatory changes, geopolitical tensions, or environmental disruptions, ensuring continuous production and delivery of critical APIs. This resilience makes Munit a trusted partner for companies prioritizing business continuity. Why pharmaceutical companies choose Munit for advanced micronization and milling Munit’s proprietary MC Jet Mill is a testament to its engineering excellence. For heat-sensitive APIs, Munit’s cryogenic micronization process uses liquid nitrogen to cool materials, preventing thermal degradation and preserving the integrity of delicate molecules. This is particularly valuable for biologics and APIs with low melting points, where stability is paramount. Additionally, Munit’s under containment micronization employs advanced systems to safely handle HPAPIs, protecting both operators and the environment while meeting stringent regulatory standards.  Their co-micronization service, which processes APIs alongside excipients, further enhances formulation stability and solubility, offering innovative solutions for complex drug profiles. These capabilities, executed under Good Manufacturing Practices (GMP), make Munit a reliable choice for pharmaceutical companies seeking precision and quality. While micronization is Munit’s flagship, it offers milling services through an array of technologies, each suited to specific needs. The Pin Mill uses a grinding chamber and particle size reduction is achieved due impact against a high-speed pin rotor, producing sizes from 50 to 150 microns. It’s particularly effective for APIs needing improved flow for tableting, offering precise size control that ensures uniformity. The Quadro Co-Mill excels at soft de-lumping and homogenization, using a conical sieve and impeller to gently process powders without altering primary particle sizes. For tougher materials, the HammerMill C-10 employs hammer bars on a rotor to crush particles. State-of-the-Art Particle Engineering: Munit's strategic innovation push delivers next-gen solutions Munit’s leadership in micronization is underpinned by a deliberate and sustained investment in innovation — aimed at building the next generation of particle size engineering. In response to client challenges with condensation and product degradation, Munit developed a proprietary conditioning system that precisely controls humidity and temperature. Engineered with ergonomic design and fluid dynamics principles, their machine represents a qualitative leap in conditioning. Munit's new AIFA-approved Building C transforms the Italian hub's capacity. Equipped for high potent, toxic, cytotoxic, and cytostatic compounds, alongside hormones, it features cutting-edge safety systems and integrated technologies, enabling broader API processing with precision and compliance. Munit has merged quality assurance and regulatory affairs into one strategic unit, streamlining workflows and enhancing client responsiveness during critical validation phases. This delivers tailored regulatory support and accelerates time-to-market. These initiatives position Munit at the forefront of particle size engineering, where state-of-the-art innovation, regulatory excellence, and client-centric design converge to set new industry standards. Our view The API micronization market is projected to grow 49 percent to US$ 3.68 billion by 2030. In this evolving landscape, companies that combine deep technical expertise with operational resilience are positioned to capture the greatest value. Munit SA exemplifies this winning formula.
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    Impressions: 6926

    https://www.pharmacompass.com/radio-compass-blog/global-api-micronization-market-set-to-surge-49-by-2030-led-by-specialized-industry-pioneers

    #Phispers by PHARMACOMPASS
    10 Sep 2025
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    NEWS #PharmaBuzz

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    Hetero's Generics HCTZ Olmesartan Receives Approval in US
    Hetero's Generics HCTZ Olmesartan Receives Approval in US

    25 Jul 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209199

    FDA
    25 Jul 2025
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    Axsome Therapeutics Settles Sunosi Patent Dispute with Hetero Lab
    Axsome Therapeutics Settles Sunosi Patent Dispute with Hetero Lab

    27 May 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/05/27/3088458/33090/en/Axsome-Therapeutics-Settles-SUNOSI-solriamfetol-Patent-Litigation-with-Hetero-Labs-Ltd.html

    GLOBENEWSWIRE
    27 May 2025
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    Hetero`s Generics Eltrombopag Olamine Receives Approval in US
    Hetero`s Generics Eltrombopag Olamine Receives Approval in US

    17 Jan 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206788

    FDA
    17 Jan 2025
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    6 pharma companies sign MoUs with Telangana for Pharma City
    6 pharma companies sign MoUs with Telangana for Pharma City

    23 Nov 2024

    // BUSINESS STD

    https://www.business-standard.com/industry/news/six-pharma-companies-sign-mous-with-telangana-govt-for-pharma-city-124112201333_1.html

    BUSINESS STD
    23 Nov 2024
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    Hetero Labs`s Generics Mycophenolate Mofetil Receives Approval in US
    Hetero Labs`s Generics Mycophenolate Mofetil Receives Approval in US

    22 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208119

    FDA
    22 Oct 2024
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    Hetero`s Generics Azacitidine Receives Approval in US
    Hetero`s Generics Azacitidine Receives Approval in US

    15 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215765

    FDA
    15 Oct 2024
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    ALL APIs

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

    01

    Amlodipine Besylate

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

    FNCE
    Not Confirmed
    arrow

    Amlodipine Besylate

    India

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

    arrow
    FNCE
    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 : 2012-12-27

    Pay. Date : 2012-12-17

    DMF Number : 18787

    Submission : 2005-09-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-003 - Rev 04

    Issue Date : 2018-04-12

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10912

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Andhra Pradesh, INDIA

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-19

    Valid Till : 2028-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Co., Ltd.

    Registration Date : 2022-10-18

    Registration Number : 20120120-130-H-183-36(7)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana, India

     VMF Others AUDIT
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    02

    Atomoxetin Hydrochloride

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

    FNCE
    Not Confirmed
    arrow

    Atomoxetin Hydrochloride

    India

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

    arrow
    FNCE
    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 : 20246

    Submission : 2007-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-128 - Rev 01

    Issue Date : 2022-08-29

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10156

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0021

    Start Marketing Date : 2002-11-26

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Youngjin Pharmaceutical Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : Su3838-3-ND(7)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA

     VMF Others AUDIT
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    Place

    03

    Bicalutamide

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

    FNCE
    Not Confirmed
    arrow

    Bicalutamide

    India

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

    arrow
    FNCE
    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 : 18496

    Submission : 2005-07-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-254 - Rev 03

    Issue Date : 2025-04-07

    Type : Chemical

    Substance Number : 2196

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10046

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2014-02-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0001

    Start Marketing Date : 1995-10-04

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Escitalopram Oxalate

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

    FNCE
    Not Confirmed
    arrow

    Escitalopram Oxalate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-17

    Pay. Date : 2013-03-07

    DMF Number : 17960

    Submission : 2004-12-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-080 - Rev 06

    Issue Date : 2023-10-27

    Type : Chemical

    Substance Number : 2733

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10125

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0007

    Start Marketing Date : 2002-08-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2025-07-25

    Registration Number : 20180604-209-J-223(9)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    Place

    05

    Irbesartan

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

    FNCE
    Not Confirmed
    arrow

    Irbesartan

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-27

    Pay. Date : 2016-05-12

    DMF Number : 17507

    Submission : 2004-07-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-104 - Rev 04

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 2465

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10007

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2016-01-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0005

    Start Marketing Date : 1997-09-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    06

    Lamivudine

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

    FNCE
    Not Confirmed
    arrow

    Lamivudine

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-27

    Pay. Date : 2012-12-03

    DMF Number : 18252

    Submission : 2005-04-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-160 - Rev 02

    Issue Date : 2017-08-10

    Type : Chemical

    Substance Number : 2217

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10157

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0016

    Start Marketing Date : 1995-11-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Levetiracetam

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

    FNCE
    Not Confirmed
    arrow

    Levetiracetam

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-30

    DMF Number : 17738

    Submission : 2004-10-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-113 - Rev 02

    Issue Date : 2024-11-25

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10091

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2020-07-29

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0065

    Start Marketing Date : 2006-07-31

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmawon Co., Ltd.

    Registration Date : 2025-05-16

    Registration Number : 20120210-183-I-21-19(7)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Unit-Ⅰ, Sy.No. 10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    Market
    Place

    08

    Lisinopril

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

    FNCE
    Not Confirmed
    arrow

    Lisinopril

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-11

    Pay. Date : 2012-11-29

    DMF Number : 16510

    Submission : 2003-03-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-197 - Rev 02

    Issue Date : 2024-07-03

    Type : Chemical

    Substance Number : 1120

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10145

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2010-04-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-19

    Valid Till : 2028-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0009

    Start Marketing Date : 1987-12-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    09

    Losartan Potassium

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

    FNCE
    Not Confirmed
    arrow

    Losartan Potassium

    India

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

    arrow
    FNCE
    Not Confirmed
    • fda
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    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-30

    Pay. Date : 2013-04-23

    DMF Number : 19988

    Submission : 2006-11-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-247 - Rev 09

    Issue Date : 2024-12-02

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10096

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-06-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0008

    Start Marketing Date : 1995-04-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    10

    Olanzapine

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

    FNCE
    Not Confirmed
    arrow

    Olanzapine

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-24

    Pay. Date : 2013-12-10

    DMF Number : 20591

    Submission : 2007-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-215 - Rev 00

    Issue Date : 2019-01-29

    Type : Chemical

    Substance Number : 2258

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10065

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2015-03-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-19

    Valid Till : 2028-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0026

    Start Marketing Date : 1996-09-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2021-05-18

    Registration Number : 20210518-209-J-928

    Manufacturer Name : Hetero Drugs Limited Unit I

    Manufacturer Address : Survey. No. 213, 214 and 255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    USDMF

    read-more
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    01

    Abacavir Sulfate

    India
    FNCE
    Not Confirmed
    arrow

    02

    Abacavir Sulfate (process-ii), Usp

    India
    FNCE
    Not Confirmed
    arrow

    03

    Abemaciclib

    India
    FNCE
    Not Confirmed
    arrow

    04

    Abiraterone Acetate

    India
    FNCE
    Not Confirmed
    arrow

    05

    Acyclovir

    India
    FNCE
    Not Confirmed
    arrow

    06

    Afatinib Dimaleate

    India
    FNCE
    Not Confirmed
    arrow

    07

    Afatinib Dimaleate (form A)

    India
    FNCE
    Not Confirmed
    arrow

    08

    Alectinib Hydrochloride

    India
    FNCE
    Not Confirmed
    arrow

    09

    Alfuzosin Hydrochloride

    India
    FNCE
    Not Confirmed
    arrow

    10

    Allopurinol

    India
    FNCE
    Not Confirmed
    arrow
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    NDC API

    read-more
    read-more

    01

    ABACAVIR SULFATE

    India
    FNCE
    Not Confirmed
    arrow

    ABACAVIR SULFATE

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 68554-0032

    Start Marketing Date : 1998-12-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

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    Web Link

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    Market
    Place

    02

    ABACAVIR SULFATE

    India
    FNCE
    Not Confirmed
    arrow

    ABACAVIR SULFATE

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 68554-0063

    Start Marketing Date : 1998-12-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

    Product
    Web Link

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    Market
    Place

    03

    ABEMACICLIB

    India
    FNCE
    Not Confirmed
    arrow

    ABEMACICLIB

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 68554-0173

    Start Marketing Date : 2017-09-28

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

    Product
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    Market
    Place

    04

    ABIRATERONE ACETATE

    India
    FNCE
    Not Confirmed
    arrow

    ABIRATERONE ACETATE

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 68554-0082

    Start Marketing Date : 2011-04-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

    Product
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    Market
    Place

    05

    ACYCLOVIR

    India
    FNCE
    Not Confirmed
    arrow

    ACYCLOVIR

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 65977-0058

    Start Marketing Date : 1982-03-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

    Product
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    Market
    Place

    06

    ACYCLOVIR

    India
    FNCE
    Not Confirmed
    arrow

    ACYCLOVIR

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 68554-0159

    Start Marketing Date : 1982-03-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
    Place

    07

    AFATINIB DIMALEATE

    India
    FNCE
    Not Confirmed
    arrow

    AFATINIB DIMALEATE

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 68554-0107

    Start Marketing Date : 2013-07-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
    Place

    08

    ALECTINIB HYDROCHLORIDE

    India
    FNCE
    Not Confirmed
    arrow

    ALECTINIB HYDROCHLORIDE

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 68554-0150

    Start Marketing Date : 2015-12-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    09

    ALFUZOSIN HYDROCHLORIDE

    India
    FNCE
    Not Confirmed
    arrow

    ALFUZOSIN HYDROCHLORIDE

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 65977-0023

    Start Marketing Date : 2003-12-06

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
    Place

    10

    ALLOPURINOL

    India
    FNCE
    Not Confirmed
    arrow

    ALLOPURINOL

    India
    arrow
    FNCE
    Not Confirmed
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    Hetero Drugs

    NDC Package Code : 65977-0124

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Drugs in Development

    read-more
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    Hetero Gets CDSCO Panel Nod to Study Tedizolid Phosphate for Bacterial Skin Infections

    Details:

    Tedizolid phosphate is an oxazolidinone-class antibacterial drug indicated in adult patients for the treatment of acute bacterial skin and skin structure infections.


    Lead Product(s): Tedizolid,Inapplicable

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tedizolid Phosphate-Generic

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 16, 2024

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    01

    Hetero Drugs

    India
    arrow
    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    India
    arrow
    Aus. Peptide Conference
    Not Confirmed
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    Lead Product(s) : Tedizolid,Inapplicable

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Hetero Gets CDSCO Panel Nod to Study Tedizolid Phosphate for Bacterial Skin Infections

    Details : Tedizolid phosphate is an oxazolidinone-class antibacterial drug indicated in adult patients for the treatment of acute bacterial skin and skin structure infections.

    Product Name : Tedizolid Phosphate-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 16, 2024

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    Hetero’s ‘NIRMACOM’ is World’s First Generic Version Of COVID-19 Oral Drug ‘PAXLOVID’ To Receive WHO Prequalification

    Details:

    Hetero’s ‘NIRMACOM’ (nirmatrelvir), a generic version of Pfizer’s COVID-19 oral antiviral drug ‘PAXLOVID’ is co-packaged with ritonavir tablets. The combi pack, launched by Hetero as NIRMACOM, will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet).


    Lead Product(s): Nirmatrelvir,Ritonavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Nirmacom

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 26, 2022

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    02

    Hetero Drugs

    India
    arrow
    Aus. Peptide Conference
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    Hetero Drugs

    India
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    Lead Product(s) : Nirmatrelvir,Ritonavir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Hetero’s ‘NIRMACOM’ is World’s First Generic Version Of COVID-19 Oral Drug ‘PAXLOVID’ ...

    Details : Hetero’s ‘NIRMACOM’ (nirmatrelvir), a generic version of Pfizer’s COVID-19 oral antiviral drug ‘PAXLOVID’ is co-packaged with ritonavir tablets. The combi pack, launched by Hetero as NIRMACOM, will contain nirmatrelvir 150 mg (2 tablets) and ...

    Product Name : Nirmacom

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 26, 2022

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    Pfizer's "Game-Changing" COVID-19 pill, Paxlovid, Gets India’s DCGI Nod

    Details:

    India's drug regulator approved antiviral medication Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for restricted emergency use against Covid-19 amid rising infections in the country.


    Lead Product(s): Nirmatrelvir,Ritonavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Recipient: Pfizer Inc

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 23, 2022

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    03

    Hetero Drugs

    India
    arrow
    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    India
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    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Nirmatrelvir,Ritonavir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Recipient : Pfizer Inc

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pfizer's "Game-Changing" COVID-19 pill, Paxlovid, Gets India’s DCGI Nod

    Details : India's drug regulator approved antiviral medication Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for restricted emergency use against Covid-19 amid rising infections in the country.

    Product Name : Paxlovid

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 23, 2022

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    Natco and Hetero Awaiting Market Authorization from DCGI on Molnupiravir After Submitting Phase-3 Trial Data

    Details:

    Molnupiravir is an investigational medicine developed by US based pharma firm Merc used to treat SARS-CoV-2 infection. In India, Merck Pharma Company had signed licensing agreements with various Indian pharma firms like Cipla, Dr Reddy’s, Emcure, Hetero labs and Sun Pharma.


    Lead Product(s): Molnupiravir,Inapplicable

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Molnunat

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Recipient: Natco Pharma

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 30, 2021

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    04

    Hetero Drugs

    India
    arrow
    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    India
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    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Lead Product(s) : Molnupiravir,Inapplicable

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Recipient : Natco Pharma

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Natco and Hetero Awaiting Market Authorization from DCGI on Molnupiravir After Submitting Phase-3 ...

    Details : Molnupiravir is an investigational medicine developed by US based pharma firm Merc used to treat SARS-CoV-2 infection. In India, Merck Pharma Company had signed licensing agreements with various Indian pharma firms like Cipla, Dr Reddy’s, Emcure, Heter...

    Product Name : Molnunat

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 30, 2021

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    Hetero Enters Into a Voluntary Licensing Agreement with MSD for the Manufacturing and Distribution of ‘Molnupiravir

    Details:

    Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.


    Lead Product(s): Molnupiravir,Inapplicable

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Recipient: Merck & Co

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement April 27, 2021

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    05

    Hetero Drugs

    India
    arrow
    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    India
    arrow
    Aus. Peptide Conference
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Lead Product(s) : Molnupiravir,Inapplicable

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Recipient : Merck & Co

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Hetero Enters Into a Voluntary Licensing Agreement with MSD for the Manufacturing and Distribution...

    Details : Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    April 27, 2021

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    Hetero Announces the Approval and Launch of First Generic ‘COVIFOR’ (Remdesivir) in India for the Treatment of Covid-19

    Details:

    Hetero announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19.


    Lead Product(s): Remdesivir,Inapplicable

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Covifor

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 21, 2020

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    06

    Hetero Drugs

    India
    arrow
    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    India
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    Aus. Peptide Conference
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Lead Product(s) : Remdesivir,Inapplicable

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Hetero Announces the Approval and Launch of First Generic ‘COVIFOR’ (Remdesivir) in India for ...

    Details : Hetero announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19.

    Product Name : Covifor

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 21, 2020

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    01

    GMP Certified

    EU
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    GMP Certified

    EU
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    Hetero Drugs

    Type : GMP Certificates

    Number : 15/08782-9

    EudraGMDP Key : 37990

    Country : India

    Issue Date : 2016-01-08

    Post Code : Pin-509301

    NCA Ref : 379901452062...

    City : TELANGANA

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    02

    GMP Certified

    EU
    Aus. Peptide Conference
    Not Confirmed
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    GMP Certified

    EU
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    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37672

    Country : India

    Issue Date : 2015-11-23

    Post Code : 502313

    NCA Ref : 00023335

    City : Medak - District, Bonth...

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    03

    GMP Certified

    EU
    Aus. Peptide Conference
    Not Confirmed
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    GMP Certified

    EU
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    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37707

    Country : India

    Issue Date : 2015-11-23

    Post Code : PIN - 500 055

    NCA Ref : 00023323

    City : Telangana

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    04

    GMP Certified

    EU
    Aus. Peptide Conference
    Not Confirmed
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    GMP Certified

    EU
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    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37706

    Country : India

    Issue Date : 2015-11-23

    Post Code : 502319

    NCA Ref : 00023331

    City : Medak District, Gaddapo...

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    05

    GMP Certified

    EU
    Aus. Peptide Conference
    Not Confirmed
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    GMP Certified

    EU
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    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37706

    Country : India

    Issue Date : 2015-11-23

    Post Code : 502319

    NCA Ref : 00023331

    City : Medak District, Gaddapo...

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    06

    GMP Certified

    EU
    Aus. Peptide Conference
    Not Confirmed
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    GMP Certified

    EU
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    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37672

    Country : India

    Issue Date : 2015-11-23

    Post Code : 502313

    NCA Ref : 00023335

    City : Medak - District, Bonth...

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    07

    GMP Certified

    EU
    Aus. Peptide Conference
    Not Confirmed
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    GMP Certified

    EU
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    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : DK API-H 00...

    EudraGMDP Key : 18133

    Country : India

    Issue Date : 2015-02-24

    Post Code : 502313

    NCA Ref : S.No.s 213, ...

    City : Jinneram Mandal

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    08

    GMP Certified

    EU
    Aus. Peptide Conference
    Not Confirmed
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    GMP Certified

    EU
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    Aus. Peptide Conference
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : MT/002HM/20...

    EudraGMDP Key : 23591

    Country : Malta

    Issue Date : 2014-02-25

    Post Code : PLA3000

    NCA Ref : 235911392908...

    City : Paola

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    09

    GMP Certified

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    GMP Certified

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    Aus. Peptide Conference
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    Hetero Drugs

    Type : GMP Certificates

    Number : 11/09557-9

    EudraGMDP Key : 11251

    Country : India

    Issue Date :

    Post Code : Pin-509301

    NCA Ref : 1.1251132258...

    City : Andhra Pradesh

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    10

    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : HeteroLabs/...

    EudraGMDP Key : 10988

    Country : India

    Issue Date :

    Post Code : Andhra Pradesh

    NCA Ref : 1.0988131498...

    City : Jadcherla Mandal

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    Contact Hetero Drugs and get a quotation

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