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DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines.

Impressions: 2749

FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim). Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for biosimilars has propelled growth in contract manufacturing. Some of the leading contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over the recent years, regulatory agencies like the FDA and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015, FDA has approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and Canadian markets, Amgen and Sandoz are tied in the first place with 13 approved biosimilars each. Samsung Biologics has nine approved biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11 drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 — down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable biosimilars this year. Interchangeable biosimilars meet additional requirements and may be substituted for its reference product by a pharmacist without consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer drug denosumab (Prolia and Xgeva) in Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars for eye drug aflibercept (Eylea) in Opuviz and Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5 trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two percent of prescriptions, they account for 46 percent of all pharmaceutical spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4 billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US savings are projected to reach US$ 181 billion through 2027. Between 2026 and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop 19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April and May of this year, respectively.Opdivo (nivolumab), belonging to the same class of drugs, competes with Keytruda and is also set to lose patent protection in 2028. It hauled in US$ 10 billion in total global sales in 2023 for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between 2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith over 2 billion people worldwide unable to access life-saving medicines, biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira. In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.

Impressions: 2195

DMF submissions from China jump 42% as India continues to top list in Q1 2024

Generic drugs play a crucial role in providing access to life-saving drugs at affordable prices. To that end, drugmakers submit Drug Master Files (DMFs) or their ‘recipes for making generics’ to the US Food and Drug Administration (FDA) for review. Of these, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs.PharmaCompass has been reviewing Type II submissions for several years now. We have noticed that these filings have been increasing in recent years. There has been a 33.5 percent increase in Type II DMF submissions since Q1 2018 (when 176 Type II DMFs had been submitted). However, at 235, the first quarter (Q1) of 2024 saw only a 1.3 percent increase in DMF submissions over Q1 2023. In Q1 2023, DMF submissions had increased by 21.5 percent (over Q1 2022).Of the 235 Type II submissions received by the FDA in Q1 of this year, only 35 (or around 15 percent) had their review completed under the Generic Drug User Fee Act (GDUFA). The total number of reviews completed by the US federal agency so far this year is 129.In all, FDA received 353 Type II, III, IV, and V DMF submissions, compared to 291 in Q1 2023, an increase of 21.3 percent.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available)DMF submissions from India dip 1.8%; China witnesses 42% rise in filings As has been the trend, India (dubbed as the pharmacy of the world) and China filed the maximum DMF submissions, with 107 and 101 submissions respectively. However, DMFs filed by Indian companies saw a marginal dip of 1.8 percent in Q1 2024 — in Q1 2023, Indian companies had filed 109 Type II DMFs. Meanwhile, DMF filings by Chinese drugmakers increased 42.2 percent in Q1 2024, up from 71 in Q1 2023.India’s MSN Laboratories was the clear leader with 15 DMF submissions to the FDA, while China’s Sichuan Elixir Pharmaceutical came a distant second with nine submissions. Indian drugmakers Aurobindo Pharma and Global Calcium (with seven submissions each) were tied at third position. There were two players at the fifth spot — India’s Dr. Reddy’s Laboratories and China’s Zhejiang Jingsheng Pharmaceutical — as both these drugmakers registered six submissions each.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Diabetes, cancer drugs emerge as hot molecules in Q1 2024Approved in June 2020, triheptanoin is the first and only FDA-approved treatment for children and adults with long-chain fatty acid oxidation disorders (LC-FAOD). At five, triheptanoin saw the maximum DMF filings. Four of those applications have already been positively reviewed.Anti-diabetic drug sitagliptin phosphate monohydrate saw four DMF filings. Empagliflozin, the API found in Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, drew three DMF filings in Q1 2024.In the US, Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC). Three DMF applications were submitted for lurbinectedin. Similarly, ruxolitinib phosphate, used for the treatment of patients with intermediate or high-risk myelofibrosis, also received three DMF applications.Semaglutide — the glucagon-like peptide-1 receptor agonist that catapulted Novo Nordisk to the position of the most valuable public company in Europe — received three DMF filings. Semaglutide’s arch rival, tirzepatide, also drew three DMF filings.AstraZeneca’s Brilinta (ticagrelor) plus aspirin is currently approved in over 115 countries for the prevention of stroke, heart attack, and other events in adults with acute coronary syndrome (ACS). Ticagrelor received three DMF submissions. Vonoprazan fumarate, a first-in-class potassium-competitive acid blocker to treat acid-related diseases, also received three DMF submissions.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Eighteen DMFs filed for first time in Q1 2024 During the first quarter of this year, 14 drugs saw first time filing of DMFs. Together, these 14 drugs attracted 18 DMF filings with tirzepatide topping the list with three submissions from Chinese companies.The 14 drugs that saw first time filing were clascoterone, capmatinib hydrochloride, niraparib tosylate monohydrate, vibegron, cabozantinib sulfate, ruxolitinib hemifumarate, ripretinib, ruxolitinib, ruxolitinib mesylate, tucatinib hemiethanolate, tecovirimat, tirzepatide, tolvaptan povidone, and azilsartan.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Our viewUntil 2020, DMF submissions by Indian companies used to be double those of Chinese and American firms put together. In 2022, DMF filings from India began to dip, while submissions by Chinese companies began to rise. In the first half of 2023, there was a 46.5 percent rise in DMF submissions from China. The gap between DMF filings by India and China has narrowed down considerably this year. The reasons behind this phenomenon may be multiple. But it definitely implies that America will find it increasingly difficult to reduce its reliance on China.

Impressions: 2989

NEWS #PharmaBuzz

Dr Reddy's launches medication to treat chronic constipation

29 Oct 2024

// PRESS RELEASE

Dr. Reddy's Launches Menopause Support Program For Employees

14 Oct 2024

// BUSINESSWIRE

PE firms queue up for Novartis' Indian arm

12 Oct 2024

// ECONOMICTIMES

Aurigene reports Positive Ph 1 trial for CAR-T cell therapy in India

09 Oct 2024

// PRESS RELEASE

Dr Reddy's sign voluntary licenses with Gilead for HIV drug

02 Oct 2024

// PRESS RELEASE

Dr. Reddys`s Generics Varenicline Tartrate Receives Approval in US

01 Oct 2024

// FDA

ALL APIs

01

Atorvastatin

India

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

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

USDMF

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CEP/COS

JDMF

EU-WC

NDC KDMF

VMF Others AUDIT

02

Cetirizine Dihydrochloride

India

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

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

USDMF

CEP/COS

JDMF

EU-WC

NDC

KDMF

VMF Others AUDIT

03

Clopidogrel

India

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

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

USDMF

CEP/COS

JDMF

EU-WC

NDC

KDMF

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04

Fexofenadine Hydrochloride

India

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

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

USDMF

CEP/COS

JDMF

EU-WC

NDC KDMF

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05

Finasteride

India

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

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

USDMF

CEP/COS

JDMF

EU-WC

NDC KDMF

VMF Others AUDIT

06

Gemcitabine

India

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

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

USDMF

CEP/COS

JDMF

EU-WC

NDC KDMF

VMF Others AUDIT

07

Levetiracetam

India

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

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

USDMF

CEP/COS

JDMF

EU-WC

NDC

KDMF

VMF Others AUDIT

08

Nizatidine

India

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

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

USDMF

CEP/COS

JDMF

EU-WC

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KDMF

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09

Ondansetron Hydrochloride

India

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

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

USDMF

CEP/COS

JDMF

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10

Rabeprazole

India

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

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

USDMF

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JDMF

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USDMF

01

Abiraterone Acetate

India

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

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-13

Pay. Date : 2014-05-05

DMF Number : 28038

Submission : 2014-03-27

Status : Active

Type : II

02

Amlodipine Besilate Usp

India

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

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-21

Pay. Date : 2013-05-10

DMF Number : 16473

Submission : 2003-03-19

Status : Active

Type : II

03

Apalutamide

India

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

GDUFA

DMF Review : Complete

Rev. Date : 2020-10-28

Pay. Date : 2020-09-30

DMF Number : 34667

Submission : 2020-03-24

Status : Active

Type : II

04

Apalutamide (amorphous)

India

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35740

Submission : 2021-03-25

Status : Active

Type : II

05

Apixaban

India

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

GDUFA

DMF Review : Complete

Rev. Date : 2016-03-11

Pay. Date : 2015-09-30

DMF Number : 29707

Submission : 2015-09-22

Status : Active

Type : II

06

Apremilast (form B)

India

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

GDUFA

DMF Review : Complete

Rev. Date : 2017-01-05

Pay. Date : 2016-11-15

DMF Number : 30732

Submission : 2016-09-30

Status : Active

Type : II

07

Apremilast [amorphous]

India

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

GDUFA

DMF Review : Complete

Rev. Date : 2017-10-02

Pay. Date : 2017-08-29

DMF Number : 31356

Submission : 2017-06-02

Status : Active

Type : II

08

Atomoxetine Hydrochloride Usp

India

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18440

Submission : 2005-06-22

Status : Active

Type : II

09

Atorvastatin Calcium (amorphous)

India

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

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-27

Pay. Date : 2013-02-05

DMF Number : 18468

Submission : 2005-06-29

Status : Active

Type : II

10

Atorvastatin Calcium (butylated Hydr...

India

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25902

Submission : 2012-03-23

Status : Active

Type : II

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CEP/COS

01

Amlodipine besilate

India

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

Certificate Numbers : R1-CEP 2003-007 - Rev 06

Status : Valid

Issue Date : 2017-08-23

Type : Chemical

Substance Number : 1491

02

Atorvastatin calcium, Form I, ATN proces...

India

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

Certificate Numbers : R0-CEP 2020-092 - Rev 02

Status : Valid

Issue Date : 2023-06-02

Type : Chemical

Substance Number : 2191

03

Atorvastatin calcium, Form-I

India

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

Certificate Numbers : CEP 2011-222 - Rev 02

Status : Valid

Issue Date : 2023-09-11

Type : Chemical

Substance Number : 2191

04

Capecitabine

India

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

Certificate Numbers : R1-CEP 2014-109 - Rev 02

Status : Valid

Issue Date : 2022-09-13

Type : Chemical

Substance Number : 2762

05

Capecitabine

India

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

Certificate Numbers : R1-CEP 2014-203 - Rev 00

Status : Valid

Issue Date : 2020-05-07

Type : Chemical

Substance Number : 2762

06

Cetirizine dihydrochloride

India

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

Certificate Numbers : R1-CEP 2003-049 - Rev 07

Status : Valid

Issue Date : 2018-10-01

Type : Chemical

Substance Number : 1084

07

Cetirizine dihydrochloride, Process II

India

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

Certificate Numbers : R1-CEP 2009-206 - Rev 03

Status : Valid

Issue Date : 2020-01-08

Type : Chemical

Substance Number : 1084

08

Clopidogrel hydrogen sulfate, Form II

India

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

Certificate Numbers : R0-CEP 2021-052 - Rev 01

Status : Valid

Issue Date : 2023-02-20

Type : Chemical

Substance Number : 2531

09

Clopidogrel hydrogen sulfate, Form-I

India

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

Certificate Numbers : R1-CEP 2012-059 - Rev 02

Status : Valid

Issue Date : 2022-09-27

Type : Chemical

Substance Number : 2531

10

Desloratadine

India

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

Certificate Numbers : CEP 2014-321 - Rev 02

India

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

Date of Issue : 2022-06-15

Valid Till : 2025-06-25

Written Confirmation Number : WC-0035A3

Address of the Firm : Chemical Technical Operations ...

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KDMF

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NDC API

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LISTED APIs

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Drugs in Development

01 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Elobixibat Hydrate

Therapeutic Area : Gastroenterology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Dr Reddy's Launches Medication to Treat Chronic Constipation

Details : Bixibat (elobixibat hydrate) is a bile acid transporter inhibitor, small molecule drug candidate, which is indicated for the treatment of chronic constipation.

Brand Name : Bixibat

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 28, 2024

02 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Lenacapavir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase III

Recipient : Gilead Sciences

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Dr. Reddy’s Partners with Gilead to Manufacture Lenacapavir in India and Beyond

Details : The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.

Brand Name : Sunlenca

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 02, 2024

03 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Rituximab

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Dr. Reddy’s Receives Positive CHMP Opinion from EMA for its Proposed Rituximab Biosimilar

Details : Ituxredi (rituximab) is an anti-CD20 monoclonal antibody, which is indicated for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia & rheumatoid arthritis.

Brand Name : Ituxredi

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 29, 2024

04 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Vonoprazan Fumarate

Therapeutic Area : Gastroenterology

Highest Development Status :

Recipient : Takeda Pharmaceutical

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Dr. Reddy's Signs Patent Licensing Agreement with Takeda to Commercialize Vonoprazan

Details : Under the terms of this agreement, Takeda has granted Reddy non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.

Brand Name : Vault

Molecule Type : Small molecule

Upfront Cash : Undisclosed

July 19, 2024

05 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Pertuzumab

Therapeutic Area : Oncology

Highest Development Status : Approved

Recipient : Zydus Lifesciences

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Zydus and Dr Reddy's Co-Market Pertuzumab Biosimilar

Details : Under the terms of this agreement, Dr. Reddy will receive semi-exclusive rights of Sigrima (pertuzumab) biosimilar of Perjeta from Zydus to co-market the product in India.

Brand Name : Sigrima

Molecule Type : Large molecule

Upfront Cash : Undisclosed

June 29, 2024

06 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Pertuzumab

Therapeutic Area : Oncology

Highest Development Status : Approved

Recipient : Zydus Lifesciences

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Zydus and Dr. Reddy’s License Agreement for Co-Marketing Pertuzumab Biosimilar in India

Details : Through the license agreement, Dr. Reddy’s will receive semi-exclusive rights from Zydus to co-market Womab (pertuzumab) in India for the treatment of HER2-positive breast neoplasms.

Brand Name : Womab

Molecule Type : Large molecule

Upfront Cash : Undisclosed

June 28, 2024

07 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Nicotine

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Discovery

Recipient : Haleon

Deal Size : $632.9 million

Deal Type : Acquisition

Dr. Reddy's Acquire Nicotinell and Related Portfolio

Details : Through the acquisition, Reddy will leverage the NRT portfolio, which includes Nicotinell (nicotine) in various formats such as lozenges, patches, and gum, across all applicable global market.

Brand Name : Nicotinell

Molecule Type : Small molecule

Upfront Cash : $579.8 million

June 26, 2024

08 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Cyclophosphamide

Therapeutic Area : Oncology

Highest Development Status : Approved

Recipient : Ingenus Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Dr Reddy's Signs In-Licensing Pact with Ingenus for Cancer Treatment Injection

Details : Under the in-licensing pact, Dr Reddy's USA will commercialise the Cyclophosphamide injection, an alkylating drug indicated for treatment of malignant lymphomas, for the US market.

Brand Name : Cyclophosphamide-Generic

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 12, 2024

09 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Vildagliptin

Therapeutic Area : Endocrinology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation

Deal Size : Undisclosed

Deal Type : Agreement

Dr. Reddy’s and Novartis sign distribution agreement for anti-diabetes products

Details : Novartis Pharma will be responsible for the supply of Galvus and Galvus Met to DRL. Galvus and Galvus Met are prominent assets in the Dipeptidyl Peptidase-4 (DPP4) inhibitor category.

Brand Name : Galvus

Molecule Type : Small molecule

Upfront Cash : Undisclosed

May 27, 2024

10 Dr. Reddy's Laboratories

India

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

Lead Product(s) : Denosumab

Therapeutic Area : Musculoskeletal

Highest Development Status : Phase I

Recipient : Alvotech

Deal Size : Undisclosed

Deal Type : Collaboration

Alvotech, Dr. Reddy's Collaborate on Denosumab Biosimilar in US, EU, UK

Details : The collaboration aims for commercialization of AVT03 (denosumab), a monoclonal antibody and a biosimilar to Prolia & Xgeva. It is a RANK ligand inhibitor, being evaluated in bone loss in adult men.

Brand Name : AVT03

Molecule Type : Large molecule

Upfront Cash : Undisclosed

May 21, 2024

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FDF Dossiers

01

Brand Name : ABIRATERONE ACETATE

India

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

Regulatory Info : RX

Registration Country : USA

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Packaging :

Approval Date : 2023-09-01

Application Number : 208416

Regulatory Info : RX

Registration Country : USA

02

Brand Name : N/A

India

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

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Abiraterone Acetate

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

03

Brand Name : ABIRATERONE ACETATE

India

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

Regulatory Info : RX

Registration Country : USA

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Packaging :

Approval Date : 2020-05-18

Application Number : 208416

Regulatory Info : RX

Registration Country : USA

04

Brand Name : N/A

India

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

Regulatory Info : Lead Market Dossiers- Approved in US

Registration Country : India

Abiraterone Acetate

Dosage Form : Tablet

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Approved in US

Registration Country : India

05

Brand Name : N/A

India

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

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Abiraterone Acetate

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

06

Brand Name : SECTRAL

U.S.A

SupplySide West 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Regulatory Info : DISCN

Registration Country : USA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 400MG BASE **Federa...

Packaging :

Approval Date : 1984-12-28

Application Number : 18917

Regulatory Info : DISCN

Registration Country : USA

Product
Web Link

07

Brand Name : SECTRAL

U.S.A

SupplySide West 2024

Regulatory Info : DISCN

Registration Country : USA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE **Federa...

Packaging :

Approval Date : 1984-12-28

Application Number : 18917

Regulatory Info : DISCN

Registration Country : USA

Product
Web Link

08

Brand Name : BUTALBITAL AND ACETA...

India

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

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG;50MG

Packaging :

Approval Date : 2017-12-27

Application Number : 207313

Regulatory Info : RX

Registration Country : USA

Product
Web Link

09

Brand Name : BUTALBITAL, ACETAMIN...

India

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

Regulatory Info : RX

Registration Country : USA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG

Packaging :

Approval Date : 1986-03-17

Application Number : 89007

Regulatory Info : RX

Registration Country : USA

Product
Web Link

10

Brand Name : BUTALBITAL, ACETAMIN...

India

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

Regulatory Info : RX

Registration Country : USA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG;50MG;40MG

Packaging :

Approval Date : 2019-12-17

Application Number : 210817

Regulatory Info : RX

Registration Country : USA

Product
Web Link

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FDA Orange Book

01

Brand Name : ABIRATERONE ACETATE

India

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

RLD : No

TE Code : AB

Dosage Form : TABLET; ORAL

Dosage Strength : 250MG

Approval Date : 2020-05-18

Application Number : 208416

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

02

Brand Name : ABIRATERONE ACETATE

India

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

RLD : No

TE Code : AB

Dosage Form : TABLET; ORAL

Dosage Strength : 500MG

Approval Date : 2023-09-01

Application Number : 208416

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

03

Brand Name : SECTRAL

U.S.A

World Vaccine Congress

RLD : Yes

TE Code :

Dosage Form : CAPSULE; ORAL

Dosage Strength : EQ 200MG BASE **Federal ...

Approval Date : 1984-12-28

Application Number : 18917

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

04

Brand Name : SECTRAL

U.S.A

World Vaccine Congress

RLD : Yes

TE Code :

Dosage Form : CAPSULE; ORAL

Dosage Strength : EQ 400MG BASE **Federal ...

Approval Date : 1984-12-28

Application Number : 18917

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

05

Brand Name : BUTALBITAL AND ACETA...

India

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

RLD : No

TE Code : AA

ACETAMINOPHEN; BUTALBITAL

Dosage Form : CAPSULE; ORAL

Dosage Strength : 300MG;50MG

Approval Date : 2017-12-27

Application Number : 207313

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

06

Brand Name : BUTALBITAL, ACETAMIN...

India

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

RLD : No

TE Code : AA

Dosage Form : CAPSULE; ORAL

Dosage Strength : 325MG;50MG;40MG

Approval Date : 1986-03-17

Application Number : 89007

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

07

Brand Name : BUTALBITAL, ACETAMIN...

India

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

RLD : No

TE Code : AA

Dosage Form : CAPSULE; ORAL

Dosage Strength : 300MG;50MG;40MG

Approval Date : 2019-12-17

Application Number : 210817

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

08

Brand Name : ACETAMINOPHEN AND IB...

India

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

RLD : No

TE Code :

ACETAMINOPHEN; IBUPROFEN

Dosage Form : TABLET; ORAL

Dosage Strength : 250MG;125MG

Approval Date : 2024-08-23

Application Number : 218247

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Product
Web Link

09

Brand Name : OXYCODONE AND ACETAM...

India

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

RLD : No

TE Code :

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Dosage Form : TABLET; ORAL

Dosage Strength : 325MG;2.5MG

Approval Date : 2008-10-20

Application Number : 90177

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

10

Brand Name : OXYCODONE AND ACETAM...

India

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

RLD : No

TE Code :

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Dosage Form : TABLET; ORAL

Dosage Strength : 325MG;5MG

Approval Date : 2008-10-20

Application Number : 90177

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link