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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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    SPI Pharma has been solving formulation challenges using superior functional materials.

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

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

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    FAMAR CDMO- From early development to commercial manufacturing.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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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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    India
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    7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
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    +91 40 23704923/24
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.
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    Impressions: 626

    https://www.pharmacompass.com/radio-compass-blog/fda-s-first-generic-approvals-slump-21-in-2024-novartis-top-seller-entresto-cancer-blockbuster-tasigna-lead-2024-patent-cliff

    #PharmaFlow by PHARMACOMPASS
    20 Feb 2025
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    NEWS #PharmaBuzz

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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 Lab`s Generics Milnacipran HCl Receives Approval in US
    Hetero Lab`s Generics Milnacipran HCl Receives Approval in US

    03 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205147

    FDA
    03 Oct 2024
    Share Share
    Hetero's Generic Pemetrexed Disodium Receives Approval in the U.S.
    Hetero's Generic Pemetrexed Disodium Receives Approval in the U.S.

    14 Jun 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215460

    FDA
    14 Jun 2024
    Share Share
    Hetero Labs Generic Ertugliflozin Receives Tentative Approval in US
    Hetero Labs Generic Ertugliflozin Receives Tentative Approval in US

    17 Apr 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217071

    FDA
    17 Apr 2024
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    ALL APIs

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    01

    Atomoxetin Hydrochloride

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

    Biotech Digital Meet
    Not Confirmed
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    Atomoxetin Hydrochloride

    India

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

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    Biotech Digital Meet
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    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! 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 : 2022-09-16

    Valid Till : 2025-08-08

    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 : No. 3838-3-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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    02

    Bicalutamide

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

    Biotech Digital Meet
    Not Confirmed
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    Bicalutamide

    India

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

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    Biotech Digital Meet
    Not Confirmed
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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 : R1-CEP 2012-254 - Rev 02

    Issue Date : 2023-01-09

    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 : 2022-09-16

    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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    03

    Escitalopram Oxalate

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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Escitalopram Oxalate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 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 : R1-CEP 2016-306 - Rev 00

    Issue Date : 2023-05-23

    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 : 2022-09-16

    Valid Till : 2025-08-08

    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 : Mirae Pharmchem 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

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    04

    Finasteride

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

    Biotech Digital Meet
    Not Confirmed
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    Finasteride

    India

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

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-16

    Pay. Date : 2014-05-05

    DMF Number : 20893

    Submission : 2007-09-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-351 - Rev 03

    Issue Date : 2024-11-04

    Type : Chemical

    Substance Number : 1615

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10060

    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 : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0022

    Start Marketing Date : 1992-06-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2014-09-19

    Registration Number : 20130314-94-E-111-08(1)

    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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    05

    Irbesartan

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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Irbesartan

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 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 : 2022-09-16

    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
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    06

    Lamivudine

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

    Biotech Digital Meet
    Not Confirmed
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    Lamivudine

    India

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

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    Biotech Digital Meet
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    ✖

    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 : 2022-09-16

    Valid Till : 2025-08-08

    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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    07

    Levetiracetam

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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Levetiracetam

    India

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

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    Biotech Digital Meet
    Not Confirmed
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    ✖

    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 : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0006

    Start Marketing Date : 1999-11-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Myungin Pharmaceutical Co., Ltd.

    Registration Date : 2017-08-03

    Registration Number : 20120210-183-I-21-19(6)

    Manufacturer Name : Hetero Labs Limited

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

     VMF Others AUDIT
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    08

    Lisinopril

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

    Biotech Digital Meet
    Not Confirmed
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    Lisinopril

    India

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

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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-WCarrow-down
    ✖

    Date of Issue : 2022-07-04

    Valid Till : 2025-07-03

    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Losartan Potassium

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

    Biotech Digital Meet
    Not Confirmed
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    Losartan Potassium

    India

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

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    Biotech Digital Meet
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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-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    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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    10

    Olanzapine

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

    Biotech Digital Meet
    Not Confirmed
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    Olanzapine

    India

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

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    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 : R0-CEP 2022-126 - Rev 00

    Issue Date : 2022-06-22

    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 : 2022-07-04

    Valid Till : 2025-07-03

    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 : 2024-12-31

    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

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    Abacavir Sulfate

    India
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    02

    Abacavir Sulfate (process-ii), Usp

    India
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    Not Confirmed
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    03

    Abiraterone Acetate

    India
    Biotech Digital Meet
    Not Confirmed
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    04

    Acyclovir

    India
    Biotech Digital Meet
    Not Confirmed
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    Acyclovir

    India
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    Hetero Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-10

    DMF Number : 25587

    Submission : 2011-12-13

    Status : Active

    Type : II

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    05

    Afatinib Dimaleate

    India
    Biotech Digital Meet
    Not Confirmed
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    06

    Afatinib Dimaleate (form A)

    India
    Biotech Digital Meet
    Not Confirmed
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    07

    Alectinib Hydrochloride

    India
    Biotech Digital Meet
    Not Confirmed
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    08

    Alfuzosin Hydrochloride

    India
    Biotech Digital Meet
    Not Confirmed
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    09

    Allopurinol

    India
    Biotech Digital Meet
    Not Confirmed
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    Allopurinol

    India
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    Hetero Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-03-17

    Pay. Date : 2020-12-17

    DMF Number : 35422

    Submission : 2020-12-21

    Status : Active

    Type : II

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    10

    Amifampridine Phosphate

    India
    Biotech Digital Meet
    Not Confirmed
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    01

    Abiraterone Acetate

    JDMF

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    India
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    Hetero Drugs

    Registration Number : 304MF10108

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

    Initial Date of Registration : 2022-08-03

    Latest Date of Registration : 2022-08-03

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    02

    Abiraterone acetate

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Abiraterone acetate

    India
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    Hetero Drugs

    Registration Number : 301MF10049

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

    Initial Date of Registration : 2019-08-20

    Latest Date of Registration : 2019-08-20

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    03

    Amlodipine besylate

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Amlodipine besylate

    India
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    Hetero Drugs

    Registration Number : 218MF10912

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

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration : 2006-11-10

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    04

    Amlodipine besylate "F"

    JDMF

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    Amlodipine besylate "F"

    India
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    Hetero Drugs

    Registration Number : 223MF10106

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

    Initial Date of Registration : 2011-07-15

    Latest Date of Registration : 2011-07-15

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    05

    Anastrozole

    JDMF

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    Anastrozole

    India
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    Hetero Drugs

    Registration Number : 228MF10140

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

    Initial Date of Registration : 2016-08-02

    Latest Date of Registration : 2016-08-02

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    06

    Apremi last

    JDMF

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    Apremi last

    India
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    Hetero Drugs

    Registration Number : 306MF10024

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

    Initial Date of Registration : 2024-02-07

    Latest Date of Registration : 2024-02-07

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    07

    Aripiprazole

    JDMF

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    Aripiprazole

    India
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    Hetero Drugs

    Registration Number : 306MF10017

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

    Initial Date of Registration : 2024-01-24

    Latest Date of Registration : 2024-01-24

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    08

    Aripiprazole

    JDMF

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    India
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    Hetero Drugs

    Registration Number : 228MF10005

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

    Initial Date of Registration : 2016-01-08

    Latest Date of Registration : 2016-01-08

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    09

    Atomoxetine hydrochloride

    JDMF

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    India
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    Hetero Drugs

    Registration Number : 229MF10156

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

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration : 2017-08-08

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    10

    Atorvastatin calcium hydrate [Form-I]

    JDMF

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    Atorvastatin calcium hydrate [Form-I]

    India
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    Hetero Drugs

    Registration Number : 229MF10202

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

    Initial Date of Registration : 2017-11-20

    Latest Date of Registration : 2017-11-20

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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

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

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 16, 2024

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    Hetero Drugs

    India
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    Lead Product(s) : Tedizolid

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    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 : Small molecule

    Upfront Cash : Not Applicable

    August 16, 2024

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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): Ritonavir,Nirmatrelvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Pfizer Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 23, 2022

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    Lead Product(s) : Ritonavir,Nirmatrelvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Recipient : Pfizer Inc

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    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 : Small molecule

    Upfront Cash : Not Applicable

    April 23, 2022

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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

    Therapeutic Area: Infections and Infectious Diseases Brand Name: MK-4482

    Study Phase: Phase IIIProduct Type: Small molecule

    Recipient: Merck & Co

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement April 27, 2021

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    Hetero Drugs

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    Lead Product(s) : Molnupiravir

    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 : MK-4482

    Product Type : Small molecule

    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

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Covifor

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 21, 2020

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    Hetero Drugs

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    Lead Product(s) : Remdesivir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    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 : Small molecule

    Upfront Cash : Not Applicable

    June 21, 2020

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    01

    Brand Name : ABACAVIR SULFATE

    India
    Biotech Digital Meet
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    Brand Name : ABACAVIR SULFATE

    India
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    RLD : No

    TE Code : AB

    ABACAVIR SULFATE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Approval Date : 2013-09-13

    Application Number : 91560

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ABACAVIR SULFATE

    India
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    Brand Name : ABACAVIR SULFATE

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    RLD : No

    TE Code : AA

    ABACAVIR SULFATE

    Hetero Drugs

    Dosage Form : SOLUTION; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 20MG BASE/ML

    Approval Date : 2016-09-26

    Application Number : 201107

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    Brand Name : ABACAVIR SULFATE; LA...

    India
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    Brand Name : ABACAVIR SULFATE; LA...

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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 600;300MG

    Approval Date :

    Application Number : 205412

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Brand Name : ABACAVIR; LAMIVUDINE

    India
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    Brand Name : ABACAVIR; LAMIVUDINE

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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR; LAMIVUDINE

    Dosage Strength : 60MG;30MG

    Approval Date :

    Application Number : 207369

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Brand Name : ACYCLOVIR

    India
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    Brand Name : ACYCLOVIR

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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 400MG

    Approval Date : 2013-10-29

    Application Number : 203834

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ACYCLOVIR

    India
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 800MG

    Approval Date : 2013-10-29

    Application Number : 203834

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ACYCLOVIR

    India
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : SUSPENSION; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 200MG/5ML

    Approval Date : 2022-07-01

    Application Number : 215669

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ALLOPURINOL

    India
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    Brand Name : ALLOPURINOL

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    RLD : No

    TE Code : AB

    ALLOPURINOL

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALLOPURINOL

    Dosage Strength : 100MG

    Approval Date : 2023-08-03

    Application Number : 217748

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ALLOPURINOL

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    RLD : No

    TE Code : AB

    ALLOPURINOL

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALLOPURINOL

    Dosage Strength : 300MG

    Approval Date : 2023-08-03

    Application Number : 217748

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : AMLODIPINE BESYLATE ...

    India
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    Brand Name : AMLODIPINE BESYLATE ...

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    RLD : No

    TE Code : AB

    AMLODIPINE BESYLATE; VALSARTAN

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMLODIPINE BESYLATE AND ...

    Dosage Strength : EQ 5MG BASE;160MG

    Approval Date : 2016-09-16

    Application Number : 205137

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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