AUROBINDO PHARMA LIMITED (UNIT III) DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

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

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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 817 NEWS #PharmaBuzz

media
INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
817 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

446 All APIs, 315 USDMF, 190 CEP/COS, 48 JDMF, 182 EU WC, 124 KDMF, 305 NDC API, 6 VMF, 230 Listed APIs

446 All APIs
315 USDMF
190 CEP/COS
48 JDMF
182 EU WC
124 KDMF
305 NDC API
6 VMF
230 Listed APIs

DEVELOPMENTS

39 Drugs in Development

39 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2956 FDF Dossiers, 1499 FDA Orange Book, 661 Europe, 354 Canada, 122 South Africa, 320 Listed Dossiers

2956 FDF Dossiers
1499 FDA Orange Book
661 Europe
354 Canada
122 South Africa
320 Listed Dossiers

EXCIPIENTS

1 NDC API

excipientPortfolio
1 NDC API

INSPECTIONS & REGISTRATIONS

46 FDA, 11 EDQM, 7 WHO-GMP, 14 GDUFA

inspections
46 FDA
11 EDQM
7 WHO-GMP
14 GDUFA

Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

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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 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.

DCAT WeekDCAT Week

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17-20 March, 2025

New York, USA
Pharma, Lab & Chemical...Pharma, Lab & Chemical Expo

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03-05 January, 2025

Chennai, India
DuphatDuphat

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07-09 January, 2025

Dubai World Trade Center

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CONTACT DETAILS

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Country

India

Address

Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh

Telephone

+91 (40) 6672 5000

enquiries@pharmacompass.com

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”

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

Impressions: 4919

VLOG #PharmaReel

[Sponsored by another company]

High-Quality Specialty Formulations

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions. View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities. North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country. View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial. View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent. Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company. View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.

Impressions: 4591

NEWS #PharmaBuzz

Enforcement Report - Week of January 1, 2025

01 Jan 2025

// FDA

Aurobindo Pharma Ltd up for third straight session

31 Dec 2024

// BUSINESS STD

Aurobindo`s Generics Deutetrabenazine Receives Approval in US

26 Dec 2024

// FDA

Enforcement Report - Week of December 25, 2024

25 Dec 2024

// FDA

Aurobindo Pharma Gains 2% in Trade on December 23

23 Dec 2024

// BUSINESS STD

Aurobindo, Glenmark, Zydus Recall Products in US Over Manufacturing

15 Dec 2024

// BUSINESS STD

ALL APIs

Click the button for full data set

01

Amlodipine Besylate

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

Duphat

Not Confirmed

Company profile for Aurobindo Pharma Limited

VISIT THE VIRTUAL BOOTH

Review portfolio & marketing content

CONTACT DETAILS

Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma

VLOG #PharmaReel

DATA COMPILATION #PharmaFlow

817 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

446 All APIs

315 USDMF

190 CEP/COS

48 JDMF

182 EU WC

124 KDMF

305 NDC API

6 VMF

230 Listed APIs

DEVELOPMENTS

39 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2956 FDF Dossiers

1499 FDA Orange Book

661 Europe

354 Canada

122 South Africa

320 Listed Dossiers

EXCIPIENTS

1 NDC API

INSPECTIONS & REGISTRATIONS

46 FDA

11 EDQM

7 WHO-GMP

14 GDUFA

01

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04

05

06

07

08

09

10

01

02

03

04

05

06

07

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09

10

Valid

CEP 2014-242 - Rev 01

Chemical

2024-01-16

2589

01

Valid

CEP 2024-177 - Rev 00

Chemical

2024-07-02

2589

02

Valid

CEP 2007-080 - Rev 03

Chemical

2023-11-16

1287

03

Valid

CEP 2010-005 - Rev 05

Chemical

2024-09-04