Gilead Sciences South Africa (Pty) Ltd DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

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

Virtual Booth

Contact Supplier

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

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 2838 NEWS #PharmaBuzz

media
INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
2838 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

20 All APIs, 18 USDMF, 2 JDMF, 5 KDMF, 5 NDC API

20 All APIs
18 USDMF
2 JDMF
5 KDMF
5 NDC API

DEVELOPMENTS

253 Drugs in Development

253 Drugs in Development

FINISHED DOSAGE FORMULATIONS

190 FDF Dossiers, 53 FDA Orange Book, 71 Europe, 43 Canada, 23 Australia

190 FDF Dossiers
53 FDA Orange Book
71 Europe
43 Canada
23 Australia

EXCIPIENTS

1 All Excipients, 1 JDMF

excipientPortfolio
1 All Excipients
1 JDMF

INSPECTIONS & REGISTRATIONS

21 FDA, 4 EDQM

inspections
21 FDA
4 EDQM

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

Update your Virtual Booth on PharmaCompass, ask us

About

Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff of more than 9,000 people is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in 23 marketed products that are benefiting millions of people, a pipeline of late-stage drug candidates.

DCAT WeekDCAT Week

Not Confirmed

Not Confirmed

17-20 March, 2025

New York, USA
PharmaVenuePharmaVenue

Not Confirmed

Not Confirmed

20-21 January, 2025

Barcelona
CosmoprofCosmoprof

Not Confirmed

Not Confirmed

21-23 January, 2025

Miami Beach Convention Center, Miami

List your booth number for exhibitions, ask us

CONTACT DETAILS

Click the arrow to open the dropdown

Country

U.S.A

Address

333 Lakeside Drive Foster City, CA 94404

Telephone

+1 650 574 3000

enquiries@pharmacompass.com

Website

https://www.gilead.com/

https://www.linkedin.com/company/gilead-sciences/

YouTube

Digital content

Create Content with PharmaCompass, ask us

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: 4916

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: 4560

NEWS #PharmaBuzz

Gilead, US government resolve long-running HIV patent dispute

17 Jan 2025

// PRESS RELEASE

Gilead, LEO Pharma to programs for inflammatory diseases

13 Jan 2025

// REUTERS

Merck's HIV combo treatment meets efficacy bar in Ph 3 trials

20 Dec 2024

// FIERCE BIOTECH

Gilead Sciences to Present at Upcoming Investor Conference

20 Dec 2024

// BUSINESSWIRE

AI-powered Terray is teaming up with Gilead in a fresh R&D pact

17 Dec 2024

// FIERCE BIOTECH

Gilead & Terray Announce Multi-Target Research Collaboration

17 Dec 2024

// BUSINESSWIRE

ALL APIs

Click the button for full data set

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

JDMF

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

KDMF

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

Only 10 entries up to this point, click to access all

Drugs in Development

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

Europe

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Canada

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Australia

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Excipients

Click here to find the perfect excipient manufacturers by their capabilities

All Excipients

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

JDMF

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Inspections and registrations

Upload your audits for free, ask us

FDA

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

EDQM

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Contact Gilead Sciences South Africa (Pty) Ltd and get a quotation

Gilead Sciences South Africa (Pty) Ltd is a supplier offers 17 products (APIs, Excipients or Intermediates).

Find a price of Amphotericin B bulk with DMF offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Cobicistat bulk with DMF offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Elvitegravir bulk with DMF offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Emtricitabine bulk with JDMF offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Tenofovir bulk with JDMF offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of 2-Phosphonomethyl-Pentanedioic Acid bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Aconiazide bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Didanosine bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Dobutamine Hydrochloride bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Lurtotecan bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Triacetyluridine bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of Zalcitabine bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of MFG. METHODS AND PROPERTIES OF 2'-3'-DIDEOXYADENOSINE bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDMONTON, ALBERTA, CANADA. bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of LIPOSOMAL OSI-7904 FOR INJECTION (OSI-7904L) bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION bulk offered by Gilead Sciences South Africa (Pty) Ltd

Find a price of FK506LC AND PLACEBO bulk offered by Gilead Sciences South Africa (Pty) Ltd

Company profile for Gilead Sciences