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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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DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 85 NEWS #PharmaBuzz

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INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
85 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

43 All APIs, 24 USDMF, 14 CEP/COS, 2 JDMF, 21 EU WC, 16 KDMF, 22 NDC API, 38 Listed APIs

43 All APIs
24 USDMF
14 CEP/COS
2 JDMF
21 EU WC
16 KDMF
22 NDC API
38 Listed APIs

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

147 FDF Dossiers, 31 FDA Orange Book, 116 Listed Dossiers

147 FDF Dossiers
31 FDA Orange Book
116 Listed Dossiers

INSPECTIONS & REGISTRATIONS

6 FDA, 8 EDQM, 4 WHO-GMP, 4 GDUFA

inspections
6 FDA
8 EDQM
4 WHO-GMP
4 GDUFA

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

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About

Indoco Remedies is engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs) in India. Indoco has a strong international presence in the Regulated and Emerging markets. The Company is striving to place itself on a strong promising path by expanding its business strategically, strengthening its manufacturing facilities and enhancing capabilities across the or...

DCAT WeekDCAT Week

Not Confirmed

Not Confirmed

17-20 March, 2025

New York, USA
DuphatDuphat

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Not Confirmed

07-09 January, 2025

Dubai World Trade Center
Pharmatech Expo 2025Pharmatech Expo 2025

Not Confirmed

Not Confirmed

08-10 January, 2025

Gujarat, India

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CONTACT DETAILS

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Country

India

Address

Indoco House, 166, CST Road,Santacruz (East), Mumbai 400 098

Telephone

+91-22-2654-1851

enquiries@pharmacompass.com

Website

https://www.indoco.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: 4926

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: 4652

NEWS #PharmaBuzz

Indoco Receives FDA Warning Letter

07 Jan 2025

// FDA

Indoco Remedies gets warning letter from USFDA for Goa plant

17 Dec 2024

// ECONOMICTIMES

Indoco Remedies gains on inking pact with Clarity Pharma

03 Dec 2024

// BUSINESS STD

Indoco Remedies posts Q2 FY25 consolidated loss at Rs. 9.57 Cr

28 Oct 2024

// INDPHARMAPOST

Indoco Remedies' Goa plant classified as OAI by US FDA

14 Oct 2024

// BUSINESS STANDARD

Indoco receives U.S. FDA approval for generic Cetirizine tablets

05 Oct 2024

// EXPRESSPHARMA

ALL APIs

Click the button for full data set

01

Allopurinol

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

BIO Partnering at JPM

Not Confirmed

Company profile for Indoco Remedies 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

85 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

43 All APIs

24 USDMF

14 CEP/COS

2 JDMF

21 EU WC

16 KDMF

22 NDC API

38 Listed APIs

DEVELOPMENTS

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

147 FDF Dossiers

31 FDA Orange Book

116 Listed Dossiers

INSPECTIONS & REGISTRATIONS

6 FDA

8 EDQM

4 WHO-GMP

4 GDUFA

01

02

03

04

05

06

07

08

09

10

01

02

03

04

05

06

07

08

09

10

Valid

CEP 2008-017 - Rev 04

Chemical

2023-11-20

576

01

Valid

R1-CEP 2011-031 - Rev 01

Chemical

2020-04-07

1072

02

Valid

CEP 2014-180 - Rev 01

Chemical

2024-03-20

2760

03

Valid

R0-CEP 2021-475 - Rev 00

Chemical

2023-01-11

1084

04

Withdrawn by Holder

R0-CEP 2008-176 - Rev 01

Chemical

2011-09-07