Company profile for Eli Lilly

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About

Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: “Take what you find here and make it better and better.” More than 140 years later, we remain committed to his vision through every aspect of our business and the peopl...
Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: “Take what you find here and make it better and better.” More than 140 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live.

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CONTACT DETAILS

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Country
Country
U.S.A
Address
Address
Lilly Corporate Center, Indianapolis, Indiana 46285
Telephone
Telephone
+1-317-276-2000
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INTERVIEW #SpeakPharma

[Sponsored by another company]
“Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”
This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

Impressions: 944

https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage

Radio Compass
12 Mar 2025

VLOG #PharmaReel

[Sponsored by another company]

DATA COMPILATION #PharmaFlow

[Sponsored by another company]
Top Pharma Companies & Drugs in 2024: Merck’s Keytruda maintains top spot as Novo’s semaglutide nips at its heels
In 2024, Big Pharma players consolidated and maintained their dominance, even as innovation continued to reshape the pharmaceutical landscape. The primary change last year was the meteoric rise of glucagon-like peptide-1 (GLP-1) receptor agonists that treat diabetes and help in weight loss.Amongst drugmakers, Pfizer retained its numero uno spot with an impressive US$ 63.6 billion in prescription drug sales (up 7 percent from US$ 59.56 billion reported in 2023), despite ever-shrinking Comirnaty sales, which settled at US$ 5.35 billion in 2024 (from US$ 11.22 billion in 2023).Merck secured the second position with revenues of US$ 57.4 billion, a growth of 7 percent over 2023. This performance was predominantly fueled by Keytruda, which now accounts for more than half of Merck’s total pharmaceutical revenue. Johnson & Johnson came a close third with US$ 57 billion in prescription drug sales (up from US$ 54.76 billion in 2023).AbbVie held the fourth position with US$ 56.33 billion in sales, achieving 3.7 percent growth despite the ongoing erosion of Humira revenue. This flagship immunology drug saw sales plummet 37.6 percent to approximately US$ 9 billion, a US$ 5.4 billion reduction compared to 2023. Humira’s loss was offset by AbbVie’s newer immunology assets, particularly Skyrizi and Rinvoq, both of which demonstrated exceptional growth trajectories. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)European giants Astra, Roche, Novartis, Sanofi round out top 10 list; Novo, Lilly see astounding growthWhile the top four positions were dominated by American drugmakers, European giants dominated the lower half of the top 10 list.AstraZeneca secured the fifth spot with US$ 54.1 billion in sales, thereby posting impressive growth of 18.1 percent over 2023. Roche claimed the sixth position with US$ 50.9 billion in sales while Novartis ranked seventh — with sales of US$ 50.3 billion. Novartis' impressive 10.8 percent sales growth is attributed to its innovative medicines portfolio. Oncology therapies remained a cornerstone for both these Swiss drugmakers.Bristol Myers Squibb (BMS) secured eighth position with revenues of US$ 48.3 billion, representing 7.3 percent growth over the previous year. At US$ 45 billion, Eli Lilly posted 32 percent revenue growth last year. Its GLP-1 drug Mounjaro helped Lilly move up from the tenth in 2023 to the ninth spot last year.Sanofi landed the tenth position with US$ 42.6 billion in sales, propelled largely by the expanding indications of Dupixent. The French multinational has increasingly focused on this immunology blockbuster, while also garnering more sales from its vaccine and rare disease portfolios.Novo Nordisk merits a mention as it posted an incredible 26 percent year-on-year growth. It retained its eleventh spot with US$ 40.25 billion in sales. Novo’s growth was driven almost exclusively by the extraordinary success of its GLP-1 receptor agonist portfolio. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)       Merck’s Keytruda retains throne with US$ 29.5 bn in sales, as Novo’s semaglutide nips at its heelsMoving on to drugs, Merck’s Keytruda (pembrolizumab) solidified its position as the world’s top-selling pharmaceutical product with sales exceeding US$ 29.5 billion and year-on-year growth of 17.88 percent (US$ 4.5 billion). This remarkable performance was driven by steady sales growth across more than 40 indications in the US. In 2024 alone, Keytruda secured four new approvals from the US Food and Drug Administration (FDA).However, Novo Nordisk’s semaglutide sales (Ozempic, Wegovy and Rybelsus) gave Keytruda a run for its money. Across the three blockbuster drugs, semaglutide earned the Danish drugmaker around US$ 28 billion — i.e. a year-on-year increase of 38 percent.Novo’s Ozempic (semaglutide) reached over US$ 16.7 billion in sales — a 26 percent increase from 2023. Originally approved in 2017 to improve glycemic control, Ozempic bagged additional approvals in 2020, and in January 2025. It is now approved to reduce the risk of major cardiovascular events, as well as to reduce cardiovascular risk and to lower the likelihood of chronic kidney disease in type 2 diabetes patients.Sales of Wegovy (semaglutide), the other blockbuster GLP-1 drug from Novo, grew by a whopping 85.7 percent to over US$ 8 billion.Sanofi and Regeneron’s Dupixent (dupilumab) secured the number three spot with sales of US$ 13.6 billion, representing an impressive 22.4 percent year-on-year growth. In 2024, Dupixent received three new approvals and one label update. Notably, it became the first-ever biologic medicine approved for patients with chronic obstructive pulmonary disease (COPD). View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) AbbVie’s post-Humira strategy pays off as Skyrizi surges 51%; Lilly’s Mounjaro posts 124% growthGilead Sciences’ HIV treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) showed robust growth of 13.27 percent, touching sales of US$ 13.42 billion in 2024 and emerging as the fourth largest selling drug. Biktarvy now commands over 50 percent of the US HIV treatment market. Unlike many other drugs on this list, Biktarvy faces no immediate patent challenges, with key protections expected to remain intact until 2033.BMS and Pfizer’s anticoagulant Eliquis (apixaban) claimed the fifth position with US$ 13.33 billion in sales, representing a 9.21 percent year-on-year increase. AbbVie’s Skyrizi (risankizumab) emerged as one of the fastest-growing assets with a 50.95 percent year-on-year increase, generating US$ 11.71 billion in 2024 sales, thereby surpassing Humira’s (adalimumab) diminished sales.This impressive performance, combined with Rinvoq’s (upadacitinib) growth, has prompted  AbbVie to raise its long-term outlook for these products. The company now expects combined Skyrizi and Rinvoq revenues to exceed US$ 31 billion by 2027, with Skyrizi alone projected to generate over US$ 20 billion.Johnson & Johnson’s Darzalex (daratumumab) claimed the seventh position with US$ 11.67 billion in sales, representing 19.77 percent growth over 2023.Lilly’s Mounjaro (tirzepatide) demonstrated dramatic growth with sales increasing 123.51 percent to US$ 11.54 billion. This performance was complemented by Zepbound (tirzepatide, for weight loss), which contributed US$ 4.9 billion to Lilly’s revenue. By the end of 2024, Mounjaro received FDA approval for a new indication in obstructive sleep apnea (OSA), becoming the first and only prescription medicine for moderate-to-severe OSA in adults with obesity.Stelara (ustekinumab) ranked ninth, bringing J&J sales of US$ 10.36 billion, showing a modest decline of 4.91 percent from its 2023 sales.Vertex’s triple-combination therapy Trikafta (elexacaftor/tezacaftor/ivacaftor) for treating cystic fibrosis rounded out the top ten list with sales of US$ 10.2 billion, up 14 percent from the previous year. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) Our viewIn 2024, transformative therapies like GLP-1 receptor agonists drove growth in the pharmaceutical industry. This year, we expect GLP-1 drugs to dethrone Keytruda from the number one spot. Along with novel immunology agents, we expect GLP-1 drugs to realign the pharmaceutical market.  

Impressions: 1611

https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2024-merck-s-keytruda-maintains-top-spot-as-novo-s-semaglutide-nips-at-its-heels

#PharmaFlow by PHARMACOMPASS
24 Apr 2025

NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/jj-and-eli-lilly-concealed-breast-cancer-risks-in-blockbuster-antipsychotics-for-decades-wisner-baum-lawsuit-alleges-302436429.html

PR NEWSWIRE
24 Apr 2025

https://www.reuters.com/sustainability/boards-policy-regulation/lilly-sues-four-compounders-over-copies-weight-loss-drugs-2025-04-23/

REUTERS
23 Apr 2025

https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-pill-leads-79-weight-loss-40-weeks-trial-2025-04-17/

REUTERS
19 Apr 2025

https://www.fiercepharma.com/pharma/eli-lilly-overtaking-novo-nordisk-diabetesobesity-market-analysts

FIERCE PHARMA
18 Apr 2025

https://www.fiercebiotech.com/biotech/lillys-oral-glp-1-drug-delivers-ozempic-efficacy-phase-3-diabetes-trial

FIERCE BIOTECH
18 Apr 2025

https://www.prnewswire.com/news-releases/lilly-confirms-date-and-conference-call-for-first-quarter-2025-financial-results-announcement-302430685.html

PR NEWSWIRE
17 Apr 2025

Drugs in Development

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Details:

The collaboration combines BigHat's AL/ML-powered Milliner platform with Lilly's expertise in drug discovery to develop high-quality next-generation antibodies.


Lead Product(s): Undisclosed

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Discovery PlatformProduct Type: Antibody

Recipient: BigHat Biosciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration April 17, 2025

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Eli Lilly

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Details : The collaboration combines BigHat's AL/ML-powered Milliner platform with Lilly's expertise in drug discovery to develop high-quality next-generation antibodies.

Product Name : Undisclosed

Product Type : Antibody

Upfront Cash : Undisclosed

April 17, 2025

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LY3502970 (orforglipron hemicalcium hydrate) is a once-daily oral nonpeptide GLP-1 receptor agonist. It is being evaluated in phase 3 clinical trials for the treatment of adults with Type 2 Diabetes.


Lead Product(s): Orforglipron Calcium Hydrate

Therapeutic Area: Endocrinology Brand Name: LY3502970

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 17, 2025

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Eli Lilly

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Details : LY3502970 (orforglipron hemicalcium hydrate) is a once-daily oral nonpeptide GLP-1 receptor agonist. It is being evaluated in phase 3 clinical trials for the treatment of adults with Type 2 Diabetes.

Product Name : LY3502970

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 17, 2025

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Mounjaro (tirzepatide) injection is an obesity treatment targeting GIP and GLP-1 hormone receptors. Currently it is indicated for the treatment of type 2 diabetes mellitus and obesity.


Lead Product(s): Tirzepatide

Therapeutic Area: Endocrinology Brand Name: Mounjaro

Study Phase: Approved FDFProduct Type: Peptide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 20, 2025

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Eli Lilly

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Details : Mounjaro (tirzepatide) injection is an obesity treatment targeting GIP and GLP-1 hormone receptors. Currently it is indicated for the treatment of type 2 diabetes mellitus and obesity.

Product Name : Mounjaro

Product Type : Peptide

Upfront Cash : Inapplicable

March 20, 2025

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Olumiant (baricitinib) is an oral JAK1/JAK2 inhibitor, small molecule drug candidate, which is being evaluated for the treatment of severe alopecia areata.


Lead Product(s): Baricitinib

Therapeutic Area: Dermatology Brand Name: Olumiant

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 08, 2025

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Eli Lilly

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Details : Olumiant (baricitinib) is an oral JAK1/JAK2 inhibitor, small molecule drug candidate, which is being evaluated for the treatment of severe alopecia areata.

Product Name : Olumiant

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 08, 2025

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Jaypirca (pirtobrutinib) is an oral small molecule, BTK inhibitor which being developed for the treatment of adults with R/R chronic lymphocytic leukemia.


Lead Product(s): Pirtobrutinib

Therapeutic Area: Oncology Brand Name: Jaypirca

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 28, 2025

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Eli Lilly

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Details : Jaypirca (pirtobrutinib) is an oral small molecule, BTK inhibitor which being developed for the treatment of adults with R/R chronic lymphocytic leukemia.

Product Name : Jaypirca

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 28, 2025

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LY3540378 (volenrelaxin) is a RXFP1 agonist, fusion protein drug candidate, which was being evaluated for the treatment of chronic kidney disease in adults.


Lead Product(s): Volenrelaxin

Therapeutic Area: Nephrology Brand Name: LY3540378

Study Phase: Phase IIProduct Type: Protein

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 29, 2025

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Eli Lilly

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Lead Product(s) : Volenrelaxin

Therapeutic Area : Nephrology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : LY3540378 (volenrelaxin) is a RXFP1 agonist, fusion protein drug candidate, which was being evaluated for the treatment of chronic kidney disease in adults.

Product Name : LY3540378

Product Type : Protein

Upfront Cash : Inapplicable

January 29, 2025

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LY3437943 (retatrutide) is a GCGR/GLP-1R agonist synthetic peptide candidate, which is currently being evaluated for the treatment of Atherosclerotic Cardiovascular Disease in adult.


Lead Product(s): Retatrutide

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: LY3437943

Study Phase: Phase IIIProduct Type: Peptide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 19, 2025

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Eli Lilly

U.S.A
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MAGHREB PHARMA
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Eli Lilly

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Details : LY3437943 (retatrutide) is a GCGR/GLP-1R agonist synthetic peptide candidate, which is currently being evaluated for the treatment of Atherosclerotic Cardiovascular Disease in adult.

Product Name : LY3437943

Product Type : Peptide

Upfront Cash : Inapplicable

January 19, 2025

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Omvoh (mirikizumab) is the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis & crohn's disease in adults.


Lead Product(s): Mirikizumab

Therapeutic Area: Gastroenterology Brand Name: Omvoh

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 15, 2025

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Eli Lilly

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Eli Lilly

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Details : Omvoh (mirikizumab) is the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis & crohn's disease in adults.

Product Name : Omvoh

Product Type : Antibody

Upfront Cash : Inapplicable

January 15, 2025

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Details:

Through the acquisition, Lupin will enhance its portfolio and gain the right to commercialize Humulin N (human insulin) in India. It is indicated for the treatment of diabetes mellitus.


Lead Product(s): Insulin Lispro

Therapeutic Area: Endocrinology Brand Name: Humulin N

Study Phase: Approved FDFProduct Type: Peptide

Sponsor: Lupin Ltd

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition December 30, 2024

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Eli Lilly

U.S.A
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MAGHREB PHARMA
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Eli Lilly

U.S.A
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MAGHREB PHARMA
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Details : Through the acquisition, Lupin will enhance its portfolio and gain the right to commercialize Humulin N (human insulin) in India. It is indicated for the treatment of diabetes mellitus.

Product Name : Humulin N

Product Type : Peptide

Upfront Cash : Undisclosed

December 30, 2024

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Details:

Zepbound (tirzepatide) injection is a first obstructive sleep apnea in adults with obesity treatment of its kind that activates both GIP/GLP-1 hormone receptors.


Lead Product(s): Tirzepatide

Therapeutic Area: Sleep Brand Name: Zepbound

Study Phase: Approved FDFProduct Type: Peptide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 20, 2024

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Eli Lilly

U.S.A
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MAGHREB PHARMA
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Eli Lilly

U.S.A
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Details : Zepbound (tirzepatide) injection is a first obstructive sleep apnea in adults with obesity treatment of its kind that activates both GIP/GLP-1 hormone receptors.

Product Name : Zepbound

Product Type : Peptide

Upfront Cash : Inapplicable

December 20, 2024

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FDF Dossiers

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Brand Name : Humalog Mix50

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Brand Name : Humalog Mix50

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Eli Lilly

Dosage Form : PED

Brand Name : Humalog Mix50

Dosage Strength : 100IU/ml

Packaging : 3X5IU/ml

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Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Humalog Mix50

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Brand Name : Humalog Mix50

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Eli Lilly

Dosage Form : CAT

Brand Name : Humalog Mix50

Dosage Strength : 100iu/ml

Packaging : 3X5iu/ml

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Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Humalog Mix25

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Brand Name : Humalog Mix25

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Eli Lilly

Dosage Form : CAT

Brand Name : Humalog Mix25

Dosage Strength : 100iu/ml

Packaging : 3X5iu/ml

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Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Humalog Mix25

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Brand Name : Humalog Mix25

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Eli Lilly

Dosage Form : PED

Brand Name : Humalog Mix25

Dosage Strength : 100iu/ml

Packaging : 3X5iu/ml

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Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Humalog Mix 25

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Brand Name : Humalog Mix 25

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Eli Lilly

Dosage Form : PED

Brand Name : Humalog Mix 25

Dosage Strength : 100iu/ml

Packaging : 3X5iu/ml

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Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Humalog Mix25

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Brand Name : Humalog Mix25

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MAGHREB PHARMA
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Eli Lilly

Dosage Form : SUS

Brand Name : Humalog Mix25

Dosage Strength : 100iu/ml

Packaging : 10X1iu/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Reopro

MAGHREB PHARMA
Not Confirmed
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Brand Name : Reopro

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Eli Lilly

Dosage Form : INJ

Brand Name : Reopro

Dosage Strength : 10mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

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Eli Lilly

Dosage Form : TABLET

Brand Name : VERZENIO

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2487101

Regulatory Info : Prescription

Registration Country : Canada

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09

Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

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Not Confirmed

Eli Lilly

Dosage Form : TABLET;ORAL

Brand Name : VERZENIO

Dosage Strength : 150MG

Packaging :

Approval Date : 2017-09-28

Application Number : 208716

Regulatory Info : RX

Registration Country : USA

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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

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Eli Lilly

Dosage Form : TABLET;ORAL

Brand Name : VERZENIO

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 208855

Regulatory Info :

Registration Country : USA

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Brand Name : VERZENIO

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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : VERZENIO

Dosage Strength : 50MG

Approval Date : 2017-09-28

Application Number : 208716

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : VERZENIO

Dosage Strength : 100MG

Approval Date : 2017-09-28

Application Number : 208716

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : VERZENIO

Dosage Strength : 150MG

Approval Date : 2017-09-28

Application Number : 208716

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : VERZENIO

Dosage Strength : 200MG

Approval Date : 2017-09-28

Application Number : 208716

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : VERZENIO

Dosage Strength : 50MG

Approval Date :

Application Number : 208855

RX/OTC/DISCN :

RLD :

TE Code :

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06

Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : VERZENIO

Dosage Strength : 100MG

Approval Date :

Application Number : 208855

RX/OTC/DISCN :

RLD :

TE Code :

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07

Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : VERZENIO

Dosage Strength : 150MG

Approval Date :

Application Number : 208855

RX/OTC/DISCN :

RLD :

TE Code :

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08

Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Brand Name : VERZENIO

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : VERZENIO

Dosage Strength : 200MG

Approval Date :

Application Number : 208855

RX/OTC/DISCN :

RLD :

TE Code :

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09

Brand Name : DYMELOR

MAGHREB PHARMA
Not Confirmed
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Brand Name : DYMELOR

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : DYMELOR

Dosage Strength : 500MG

Approval Date : 1982-01-01

Application Number : 13378

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Brand Name : DYMELOR

MAGHREB PHARMA
Not Confirmed
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Brand Name : DYMELOR

MAGHREB PHARMA
Not Confirmed
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Eli Lilly

Dosage Form : TABLET; ORAL

Proprietary Name : DYMELOR

Dosage Strength : 250MG

Approval Date : 1982-01-01

Application Number : 13378

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Brand Name : Verzenios

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Brand Name : Verzenios

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Eli Lilly

Dosage Form : Film-Coated Tablets

Dosage Strength : 100mg

Packaging :

Brand Name : Verzenios

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

Brand Name : Verzenios

MAGHREB PHARMA
Not Confirmed
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Brand Name : Verzenios

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Eli Lilly

Dosage Form : Film-Coated Tablets

Dosage Strength : 100mg

Packaging :

Brand Name : Verzenios

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

Brand Name : Verzenios

MAGHREB PHARMA
Not Confirmed
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Brand Name : Verzenios

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Eli Lilly

Dosage Form : Filmtabl

Dosage Strength : 150mg

Packaging :

Brand Name : Verzenios

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Verzenios

MAGHREB PHARMA
Not Confirmed
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Brand Name : Verzenios

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Eli Lilly

Dosage Form : Filmtabl

Dosage Strength : 150mg

Packaging :

Brand Name : Verzenios

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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05

Brand Name : Verzenios

MAGHREB PHARMA
Not Confirmed
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Brand Name : Verzenios

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MAGHREB PHARMA
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Eli Lilly

Dosage Form : Film-Coated Tablets

Dosage Strength : 50mg

Packaging :

Brand Name : Verzenios

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Verzenios

MAGHREB PHARMA
Not Confirmed
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Brand Name : Verzenios

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Eli Lilly

Dosage Form : Film-Coated Tablets

Dosage Strength : 50mg

Packaging :

Brand Name : Verzenios

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Strattera

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Brand Name : Strattera

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Eli Lilly

Dosage Form : Capsule, hard

Dosage Strength : 10 mg

Packaging : Blister

Brand Name : Strattera

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Brand Name : Strattera

MAGHREB PHARMA
Not Confirmed
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Brand Name : Strattera

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Eli Lilly

Dosage Form : Capsule, hard

Dosage Strength : 10 mg

Packaging : Blister

Brand Name : Strattera

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Brand Name : Strattera

MAGHREB PHARMA
Not Confirmed
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Brand Name : Strattera

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MAGHREB PHARMA
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Eli Lilly

Dosage Form : Capsule, hard

Dosage Strength : 100 mg

Packaging : Blister

Brand Name : Strattera

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Brand Name : Strattera

MAGHREB PHARMA
Not Confirmed
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Brand Name : Strattera

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MAGHREB PHARMA
Not Confirmed

Eli Lilly

Dosage Form : Capsule, hard

Dosage Strength : 18 mg

Packaging : Blister

Brand Name : Strattera

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Inspections and registrations

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FDA Audited

USA
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FDA Audited

USA
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Not Confirmed

Eli Lilly

City : Carolina

State : PR

Country/Area : US

Zip : 00987-2705

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-07-21

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FDA Audited

USA
MAGHREB PHARMA
Not Confirmed
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FDA Audited

USA
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Not Confirmed

Eli Lilly

City : Indianapolis

State : IN

Country/Area : US

Zip : 46225-1782

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-05-25

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Eli Lilly is a supplier offers 70 products (APIs, Excipients or Intermediates).

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