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    Company profile for Hetero Drugs

    As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid 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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    7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "50 Years of Innovation: Mikart

    mic"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

    This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey? Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands? At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings 

    Impressions: 2248

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    https://www.pharmacompass.com/speak-pharma/50-years-of-innovation-mikart-s-legacy-and-what-s-next-in-cdmo-excellence

    PharmaCompass
    17 Jul 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaQuality, Reliability, TrustQuality, Reliability, Trust

    Quality, Reliability, Trust
    Quality, Reliability, Trust

    reelQuality, Reliability, Trust

    This PharmaReel highlights Rochem’s capabilities in sourcing and supplying Generic APIs and Excipients, driven by Quality, Reliability, and Trust through fully cGMP-compliant operations. With over 30 years of experience and 16 offices worldwide, Rochem continues to develop partnerships across the US, China, Europe, and South America.

    Impressions: 2824

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired  Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord).  Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation. 
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    Impressions: 7131

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-veranova-carbogen-lead-adc-investments-axplora-polfa-tarchomin-famar-expand-european-footprint

    #PharmaFlow by PHARMACOMPASS
    10 Jul 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
    Share Share
    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

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    01

    Atorvastatin

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

    AGGSpend
    Not Confirmed
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    Atorvastatin

    India

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

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    AGGSpend
    Not Confirmed
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    • EDQM
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-07

    Pay. Date : 2012-12-11

    DMF Number : 26122

    Submission : 2012-06-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-049 - Rev 03

    Issue Date : 2025-05-19

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10202

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

    Initial Date of Registration : 2017-11-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0065

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0127

    Start Marketing Date : 2004-07-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Neo Co., Ltd.

    Registration Date : 2023-07-19

    Registration Number : 20200318-132-H-354-44(3)

    Manufacturer Name : Hetero Labs Limited (Unit-IX)

    Manufacturer Address : Plot No.2, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli Mandal, Anakapalli District-531 081, Andhra Pradesh, India

     VMF Others AUDIT
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    Market
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    02

    Lamivudine

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

    AGGSpend
    Not Confirmed
    arrow

    Lamivudine

    India

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

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    AGGSpend
    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 : CEP 2013-168 - Rev 01

    Issue Date : 2024-05-02

    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 : 2022-09-30

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0065

    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
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    03

    Levetiracetam

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

    AGGSpend
    Not Confirmed
    arrow

    Levetiracetam

    India

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

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    AGGSpend
    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 : 2022-09-30

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0065

    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
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    04

    Quetiapine Hemifumarate

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

    AGGSpend
    Not Confirmed
    arrow

    Quetiapine Hemifumarate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-23

    Pay. Date : 2013-07-12

    DMF Number : 20845

    Submission : 2007-09-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-153 - Rev 03

    Issue Date : 2024-12-05

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10094

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

    Initial Date of Registration : 2016-04-27

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0065

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0089

    Start Marketing Date : 2001-05-17

    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 : 2021-07-05

    Registration Number : 20120816-172-I-120-06(2)

    Manufacturer Name : Hetero Labs Limited

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

     VMF Others AUDIT
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    Market
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    05

    Amlodipine Besylate

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

    AGGSpend
    Not Confirmed
    arrow

    Amlodipine Besylate

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    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-WCInactive-api
    ✖

    Date of Issue : 2022-04-07

    Valid Till : 2025-03-07

    Written Confirmation Number : WC-0040n

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea 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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    06

    Bicalutamide

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

    AGGSpend
    Not Confirmed
    arrow

    Bicalutamide

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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-WCInactive-api
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    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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    Market
    Place

    07

    Escitalopram Oxalate

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

    AGGSpend
    Not Confirmed
    arrow

    Escitalopram Oxalate

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 2016-306 - Rev 01

    Issue Date : 2025-05-13

    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-WCInactive-api
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0136

    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 : Pharmawon Co., Ltd.

    Registration Date : 2021-04-21

    Registration Number : 20180604-209-J-223(8)

    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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    Market
    Place

    08

    Irbesartan

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

    AGGSpend
    Not Confirmed
    arrow

    Irbesartan

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
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    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-WCInactive-api
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    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
    blank

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    Market
    Place

    09

    Lisinopril

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

    AGGSpend
    Not Confirmed
    arrow

    Lisinopril

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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-WCInactive-api
    ✖

    Date of Issue : 2022-04-07

    Valid Till : 2025-03-07

    Written Confirmation Number : WC-0040n

    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

    10

    Losartan Potassium

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

    AGGSpend
    Not Confirmed
    arrow

    Losartan Potassium

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
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    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-WCInactive-api
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    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
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    EU WC

    read-more
    read-more

    01

    Abacavir Sulphate USP

    India
    AGGSpend
    Not Confirmed
    arrow

    02

    Abacavir IH

    India
    AGGSpend
    Not Confirmed
    arrow

    03

    Abacavir Sulphate IH/USP

    India
    AGGSpend
    Not Confirmed
    arrow

    04

    Abacavir Sulfate Ph. Eur.

    India
    AGGSpend
    Not Confirmed
    arrow

    05

    Abiraterone Acetate IH/USP

    India
    AGGSpend
    Not Confirmed
    arrow

    06

    Aciclovir USP/Ph.Eur

    India
    AGGSpend
    Not Confirmed
    arrow

    07

    Afatinib Dimaleate IH

    India
    AGGSpend
    Not Confirmed
    arrow

    08

    Alfuzosin Hydrochloride USP/...

    India
    AGGSpend
    Not Confirmed
    arrow

    09

    Allopurinol USP/EP

    India
    AGGSpend
    Not Confirmed
    arrow

    10

    Amlodipine Besylate USP

    India
    AGGSpend
    Not Confirmed
    arrow
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    Inspections and registrations

    Upload your audits for free, ask us

    FDA

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    01

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AGGSpend
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-09-15

    Hetero Drugs

    City : Medak District

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-09-15

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    #PharmaFlow

    02

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AGGSpend
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-14

    Hetero Drugs

    City : Sangareddy District

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-14

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    03

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AGGSpend
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-02-10

    Hetero Drugs

    City : Visakhapatnam

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-02-10

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    04

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AGGSpend
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-11-29

    Hetero Drugs

    City : Medak District

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-11-29

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    05

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AGGSpend
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-15

    Hetero Drugs

    City : Visakhapatnam

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-15

    blank

    Product
    Web Link

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    #PipelineProspector

    Data Compilation
    #PharmaFlow

    06

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AGGSpend
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-09

    Hetero Drugs

    City : Medak District

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-09

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    EDQM

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    01

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
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    GMP Certified

    EU
    arrow
    AGGSpend
    Not Confirmed

    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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    Product
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    #PharmaFlow

    02

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    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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    #PharmaFlow

    03

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    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

    blank

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    #PharmaFlow

    04

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    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
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    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...

    blank

    Product
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    #PipelineProspector

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    #PharmaFlow

    06

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    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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    Product
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    #PipelineProspector

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    #PharmaFlow

    07

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    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
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    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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    #PharmaFlow

    09

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    Not Confirmed

    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

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    Not Confirmed

    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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    WHO-GMP

    read-more
    read-more

    01

    WHO GMP Certified

    Switzerland
    AGGSpend
    Not Confirmed
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    WHO GMP Certified

    Switzerland
    arrow
    AGGSpend
    Not Confirmed
    • fda
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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Limited (Unit - 11) Vill. Kalyanpur, Chakkan Road, Baddi, Distt. Solan (H.P.)

    Country : India

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    02

    WHO GMP Certified

    Switzerland
    AGGSpend
    Not Confirmed
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    WHO GMP Certified

    Switzerland
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Sy.No.10, IDA., Gaddapotharam, Medak Dist.

    Country : India

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    03

    WHO GMP Certified

    Switzerland
    AGGSpend
    Not Confirmed
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    WHO GMP Certified

    Switzerland
    arrow
    AGGSpend
    Not Confirmed
    • fda
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    • WHO-GMP
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    Hetero Drugs

    API Manufacturer : API MANUFACTURE

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    Facility Name : HETERO DRUGS LIMITED

    Business Address : UNIT-I, Sy.No. 213, 214 and ...

    FEI Number : 3003510514

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    API Manufacturer : API MANUFACTURE

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    FEI Number : 3009225386

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    Facility Name : HETERO LABS LIMITED

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    FEI Number : 3004378446

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    FEI Number : 3009093782

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    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Hetero Labs Limited Unit-III

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    Hetero Drugs

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    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Hetero Labs Limited Unit-V

    Business Address : Sy. No. 439, 440, 441 & 458,...

    FEI Number : 3008307735

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