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    Company profile for Aurobindo Pharma Limited

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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    With Fermion, start the journey of your innovative API.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    About

    Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market...
    Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.

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    Aurobindo Pharma Limitedindia-flag Flag
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    India
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    Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh
    Telephone
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    +91 (40) 6672 5000
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    enquiries@pharmacompass.com
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    Website
    https://www.aurobindo.com/
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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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    16 Dec 2024
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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
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    NEWS #PharmaBuzz

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    Aurobindo, Glenmark, Zydus Recall Products in US Over Manufacturing
    Aurobindo, Glenmark, Zydus Recall Products in US Over Manufacturing

    15 Dec 2024

    // BUSINESS STD

    https://www.business-standard.com/industry/news/aurobindo-pharma-glenmark-and-zydus-recall-products-in-us-over-mfg-issues-124121500207_1.html

    BUSINESS STD
    15 Dec 2024
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    Aurobindo Pharma Drops for Fifth Straight Session
    Aurobindo Pharma Drops for Fifth Straight Session

    13 Dec 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/aurobindo-pharma-ltd-drops-for-fifth-straight-session-124121300545_1.html

    BUSINESS STD
    13 Dec 2024
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    Eugia Pharma receives FDA approval for Pazopanib Tablets, 200 mg
    Eugia Pharma receives FDA approval for Pazopanib Tablets, 200 mg

    09 Dec 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/eugia-pharma-receives-usfda-approval-for-pazopanib-tablets-200-mg-16506

    INDPHARMAPOST
    09 Dec 2024
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    Aurobindo gains after subsidiary inks product development pact
    Aurobindo gains after subsidiary inks product development pact

    25 Nov 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/aurobindo-pharma-gains-after-american-subsidiary-inks-product-development-pact-with-global-pharma-major-124112500199_1.html

    BUSINESS STD
    25 Nov 2024
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    Why Did Aurobindo Pharma Stock Gain 3% on November 25?
    Why Did Aurobindo Pharma Stock Gain 3% on November 25?

    25 Nov 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/news/why-has-aurobindo-pharma-stock-gained-3-in-trade-today-november-25-124112500326_1.html

    BUSINESS STD
    25 Nov 2024
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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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    ALL APIs

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    01

    Amlodipine Besylate

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

    Antibody Engineering
    Not Confirmed
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    Amlodipine Besylate

    India

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

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    Antibody Engineering
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    • fda
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-08

    Pay. Date : 2012-12-17

    DMF Number : 18965

    Submission : 2005-11-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-130 - Rev 05

    Issue Date : 2023-11-29

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10061

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India

    Initial Date of Registration : 2014-03-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0120

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65862-344

    Start Marketing Date : 2023-12-12

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2017-01-11

    Registration Number : 20121113-130-H-244-41(3)

    Manufacturer Name : Apitoria Pharma Private Limited Unit-II

    Manufacturer Address : Survey No. 10 & 13, IDA, Kazipally, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    02

    Atorvastatin

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

    Antibody Engineering
    Not Confirmed
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    Atorvastatin

    India

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

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    Antibody Engineering
    Not Confirmed
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    • EDQM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24116

    Submission : 2010-09-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-271 - Rev 02

    Issue Date : 2024-07-25

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10048

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India

    Initial Date of Registration : 2014-02-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0120

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    03

    Finasteride

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

    Antibody Engineering
    Not Confirmed
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    Finasteride

    India

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

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    Antibody Engineering
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-27

    Pay. Date : 2013-01-22

    DMF Number : 19308

    Submission : 2006-03-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-219 - Rev 02

    Issue Date : 2024-09-26

    Type : Chemical

    Substance Number : 1615

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10089

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.

    Initial Date of Registration : 2024-07-03

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-06-10

    Written Confirmation Number : WC-0017

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65862-370

    Start Marketing Date : 2023-12-15

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : The One Pharmtech Co., Ltd.

    Registration Date : 2023-05-30

    Registration Number : 20071025-94-E-50-02(12)

    Manufacturer Name : Aurobindo Pharma Limited

    Manufacturer Address : Unit - VIII, Survey No. : 10 & 13 Gaddapotharam(Village), IDA - Kazipally, Jinnaram (Mandal), Sangareddy District Telangana, India

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    04

    Hydrochlorothiazide

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

    Antibody Engineering
    Not Confirmed
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    Hydrochlorothiazide

    India

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

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    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-08

    Pay. Date : 2012-12-17

    DMF Number : 17728

    Submission : 2004-09-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-466 - Rev 01

    Issue Date : 2024-09-18

    Type : Chemical

    Substance Number : 394

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 224MF10214

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India

    Initial Date of Registration : 2012-11-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-06-10

    Written Confirmation Number : WC-0017

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65862-323

    Start Marketing Date : 2023-12-07

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Irbesartan

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

    Antibody Engineering
    Not Confirmed
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    Irbesartan

    India

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

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    Antibody Engineering
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-17

    DMF Number : 23084

    Submission : 2009-08-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-297 - Rev 01

    Issue Date : 2023-12-13

    Type : Chemical

    Substance Number : 2465

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10097

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India

    Initial Date of Registration : 2016-05-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0120

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65862-530

    Start Marketing Date : 2024-01-11

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Losartan Potassium

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

    Antibody Engineering
    Not Confirmed
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    Losartan Potassium

    India

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

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    Antibody Engineering
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-21

    Pay. Date : 2013-09-13

    DMF Number : 19671

    Submission : 2006-08-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-334 - Rev 06

    Issue Date : 2023-12-13

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 224MF10221

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India

    Initial Date of Registration : 2012-11-26

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0120

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65862-428

    Start Marketing Date : 2024-01-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hanmi Pharmaceutical Co., Ltd.

    Registration Date : 2019-04-04

    Registration Number : 20100630-122-G-63-23(3)

    Manufacturer Name : Aurobindo Pharma Ltd.

    Manufacturer Address : Unit-1, Sy. No. 379, 385, 386, 388 to 396, Borpatla(V), Hatnoora(M), Sanga Reddy District, Telangana, India

     VMF Others AUDIT
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    Market
    Place

    07

    Olanzapine

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

    Antibody Engineering
    Not Confirmed
    arrow

    Olanzapine

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23525

    Submission : 2010-02-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-294 - Rev 01

    Issue Date : 2023-11-16

    Type : Chemical

    Substance Number : 2258

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10179

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India

    Initial Date of Registration : 2014-09-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-06-10

    Written Confirmation Number : WC-0017

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59651-006

    Start Marketing Date : 2023-12-25

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    08

    Perindopril Erbumine

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

    Antibody Engineering
    Not Confirmed
    arrow

    Perindopril Erbumine

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19484

    Submission : 2006-05-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2008-009 - Rev 05

    Issue Date : 2024-01-17

    Type : Chemical

    Substance Number : 2019

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10018

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India

    Initial Date of Registration : 2015-01-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0120

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65862-425

    Start Marketing Date : 2023-12-05

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Place

    09

    Pramipexole Dihydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Pramipexole Dihydrochloride

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22789

    Submission : 2009-05-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-292 - Rev 03

    Issue Date : 2023-11-16

    Type : Chemical

    Substance Number : 2416

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10156

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India

    Initial Date of Registration : 2011-11-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-06-10

    Written Confirmation Number : WC-0017

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65862-506

    Start Marketing Date : 2024-01-11

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2020-12-08

    Registration Number : 20200107-209-J-314(3)

    Manufacturer Name : Apitoria Pharma Private Limited Unit II

    Manufacturer Address : Survey No. 10 & 13 Gaddapotharam Village, IDA-Kazipally, Jinnaram Mandal Sangareddy District, Telangana, 502319, India

     VMF Others AUDIT
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    10

    Sertraline Hydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Sertraline Hydrochloride

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17435

    Submission : 2004-05-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2008-019 - Rev 05

    Issue Date : 2024-02-07

    Type : Chemical

    Substance Number : 1705

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10098

    Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India

    Initial Date of Registration : 2014-05-14

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-06-10

    Written Confirmation Number : WC-0017

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65862-222

    Start Marketing Date : 2024-01-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Base Farm Co., Ltd.

    Registration Date : 2021-04-16

    Registration Number : 20050915-39-C-197-06(3)

    Manufacturer Name : Apitoria Pharma Private Limited Unit II

    Manufacturer Address : Survey No. 10 & 13 Gaddapotharam Village, IDA-Kazipally, Jinnaram Mandal Sangareddy District, Telangana, 502319, India

     VMF Others AUDIT
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    CEP/COS

    read-more
    read-more

    01

    Abacavir sulfate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    02

    Abacavir sulfate, Process-II

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    03

    Alfuzosin hydrochloride

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    04

    Amisulpride

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    05

    Amlodipine besilate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    06

    Amoxicillin sodium, Sterile

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    07

    Amoxicillin trihydrate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    08

    Amoxicillin trihydrate, Enzymatic proces...

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    09

    Ampicillin sodium, Sterile

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    10

    Ampicillin trihydrate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow
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    Drugs in Development

    read-more
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    Eugia Steriles Receives FDA Approval for New Injectables Facility

    Details:

    Lidocaine is a local anesthetic that's used to numb areas of the body before medical procedures, treat pain, and treat certain heart conditions.


    Lead Product(s): Lidocaine Hydrochloride

    Therapeutic Area: Neurology Brand Name: Lidocaine HCl-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 11, 2024

    blank

    01

    Eugia Pharma

    India
    arrow
    Antibody Engineering
    Not Confirmed

    Eugia Pharma

    India
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Lidocaine Hydrochloride

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Eugia Steriles Receives FDA Approval for New Injectables Facility

    Details : Lidocaine is a local anesthetic that's used to numb areas of the body before medical procedures, treat pain, and treat certain heart conditions.

    Brand Name : Lidocaine HCl-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 11, 2024

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    Aurobindo Gets USFDA Nod for Generic Version of Novo Nordisk's Vagifem

    Details:

    Vagifem-Generic (estradiol) is a USFDA approved steroid hormone which is indicated for the treatment of patients with atrophic vaginitis due to menopause.


    Lead Product(s): Estradiol

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Vagifem-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 07, 2024

    blank

    02

    Aurobindo Pharma Limited

    India
    arrow
    Antibody Engineering
    Not Confirmed

    Aurobindo Pharma Limited

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Estradiol

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurobindo Gets USFDA Nod for Generic Version of Novo Nordisk's Vagifem

    Details : Vagifem-Generic (estradiol) is a USFDA approved steroid hormone which is indicated for the treatment of patients with atrophic vaginitis due to menopause.

    Brand Name : Vagifem-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 07, 2024

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    Aurobindo Receives USFDA Approval for Mometasone Furoate Nasal Spray

    Details:

    Nasonex-Generic (mometasone furoate monohydrate) nasal spray, a corticosteroid, has received FDA approval for treating allergic rhinitis symptoms.


    Lead Product(s): Mometasone Furoate

    Therapeutic Area: Immunology Brand Name: Nasonex-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 19, 2024

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    03

    Aurobindo Pharma Limited

    India
    arrow
    Antibody Engineering
    Not Confirmed

    Aurobindo Pharma Limited

    India
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    Antibody Engineering
    Not Confirmed
    • fda
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    Lead Product(s) : Mometasone Furoate

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurobindo Receives USFDA Approval for Mometasone Furoate Nasal Spray

    Details : Nasonex-Generic (mometasone furoate monohydrate) nasal spray, a corticosteroid, has received FDA approval for treating allergic rhinitis symptoms.

    Brand Name : Nasonex-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 19, 2024

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    Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablets in Multiple Strengths

    Details:

    Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.


    Lead Product(s): Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: Emflaza

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 12, 2024

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    04

    Aurobindo Pharma Limited

    India
    arrow
    Antibody Engineering
    Not Confirmed

    Aurobindo Pharma Limited

    India
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablets in Multiple Strengths

    Details : Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.

    Brand Name : Emflaza

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 12, 2024

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    Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection

    Details:

    Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Noxafil-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 27, 2023

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    05

    Aurobindo Pharma Limited

    India
    arrow
    Antibody Engineering
    Not Confirmed

    Aurobindo Pharma Limited

    India
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Posaconazole

    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

    Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection

    Details : Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.

    Brand Name : Noxafil-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 27, 2023

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    Aurobindo Pharma Gets USFDA Nod for HIV drug

    Details:

    Darunavir tablets, generic of Prezista, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.


    Lead Product(s): Darunavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Prezista-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 29, 2023

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    06

    Aurobindo Pharma Limited

    India
    arrow
    Antibody Engineering
    Not Confirmed

    Aurobindo Pharma Limited

    India
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Darunavir

    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

    Aurobindo Pharma Gets USFDA Nod for HIV drug

    Details : Darunavir tablets, generic of Prezista, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.

    Brand Name : Prezista-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 29, 2023

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    Aurobindo Pharma Gets U.S. FDA nod for Generic Icatibant Injection

    Details:

    Icatibant injection, for subcutaneous is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema in adults 18 years of ageand older.


    Lead Product(s): Icatibant Acetate

    Therapeutic Area: Genetic Disease Brand Name: Firazyr-Generic

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 16, 2023

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    07

    Aurobindo Pharma Limited

    India
    arrow
    Antibody Engineering
    Not Confirmed

    Aurobindo Pharma Limited

    India
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Icatibant Acetate

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurobindo Pharma Gets U.S. FDA nod for Generic Icatibant Injection

    Details : Icatibant injection, for subcutaneous is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema in adults 18 years of ageand older.

    Brand Name : Firazyr-Generic

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    August 16, 2023

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    Eugia Pharma Receives USFDA Approval For Plerixafor Injection

    Details:

    Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.


    Lead Product(s): Plerixafor

    Therapeutic Area: Oncology Brand Name: Mozobil-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 25, 2023

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    08

    Eugia Pharma

    India
    arrow
    Antibody Engineering
    Not Confirmed

    Eugia Pharma

    India
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    Lead Product(s) : Plerixafor

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Eugia Pharma Receives USFDA Approval For Plerixafor Injection

    Details : Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.

    Brand Name : Mozobil-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 25, 2023

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    Aurobindo Pharma Arm Gets USFDA Nod for Sevelamer Hydrochloride Tablets

    Details:

    Sevelamer hydrochloride tablets of strengths 400 mg and 800 mg used to control serum phosphorus in patients with chronic kidney disese (CKD) on dialysis.


    Lead Product(s): Sevelamer Hydrochloride

    Therapeutic Area: Nephrology Brand Name: Renagel-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 12, 2023

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    09

    Aurobindo Pharma Limited

    India
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    Aurobindo Pharma Limited

    India
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    Antibody Engineering
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    Lead Product(s) : Sevelamer Hydrochloride

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurobindo Pharma Arm Gets USFDA Nod for Sevelamer Hydrochloride Tablets

    Details : Sevelamer hydrochloride tablets of strengths 400 mg and 800 mg used to control serum phosphorus in patients with chronic kidney disese (CKD) on dialysis.

    Brand Name : Renagel-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 12, 2023

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    Aurobindo Receives FDA Approval for Pregabalin Capsules

    Details:

    Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.


    Lead Product(s): Pregabalin

    Therapeutic Area: Neurology Brand Name: Lyrica-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 30, 2023

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    10

    Aurobindo Pharma Limited

    India
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    Antibody Engineering
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    Aurobindo Pharma Limited

    India
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    Lead Product(s) : Pregabalin

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurobindo Receives FDA Approval for Pregabalin Capsules

    Details : Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.

    Brand Name : Lyrica-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 30, 2023

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