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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.

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ALL APIs

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USDMF

01

Albuterol Sulfate Usp

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-26

Pay. Date : 2013-08-29

DMF Number : 16371

Submission : 2003-01-20

Status : Active

Type : II

02

Albuterol Usp

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16104

Submission : 2002-08-16

Status : Active

Type : II

03

Alcaftadine

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-05

Pay. Date : 2014-11-24

DMF Number : 28277

Submission : 2014-05-08

Status : Active

Type : II

Product
Web Link

04

Apixaban

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2018-07-16

Pay. Date : 2018-06-13

DMF Number : 32422

Submission : 2018-01-31

Status : Active

Type : II

05

Apixaban (process-ii)

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39444

Submission : 2024-01-31

Status : Active

Type : II

06

Apremilast

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32953

Submission : 2018-11-06

Status : Active

Type : II

07

Aripiprazole Lauroxil

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32683

Submission : 2018-03-31

Status : Active

Type : II

08

Aripiprazole Monohydrate (sterile)

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2023-09-26

Pay. Date : 2023-08-28

DMF Number : 36451

Submission : 2021-11-06

Status : Active

Type : II

09

Aripiprazole Usp (anhydrous Form - B...

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2021-11-18

Pay. Date : 2021-08-10

DMF Number : 22889

Submission : 2009-06-24

Status : Active

Type : II

10

Benzyl Albuterol, Intermediate

India

Neuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10253

Submission : 1993-05-12

Status : Active

Type : II

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EU WC

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NDC API

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LISTED APIs

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KEY PRODUCTS

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Analytical

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Analytical Method Development

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Scale Up

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API & Drug Product Development

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API Development

01

DRUG DEVELOPMENT SERVICES

India

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

Neuland is at the forefront of facilitating and accelerating drug development and cGMP manufacturing of APIs. The company’s technical and scientific teams provide reliable solutions and services to the global pharmaceutical industry.

Category : API Development

Sub Category : Overview

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

DRUG DEVELOPMENT SERVICES

02

PEPTIDE API DEVELOPMENT SERVICES

India

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

Neuland offers peptide API development by utilizing solid-phase and solution-phase peptide synthesis methods. It provides synthetic route scouting, impurity profiling, and stability studies for the development of peptides.

Category : API Development

Sub Category : Protein / Peptide

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

PEPTIDE API DEVELOPMENT SERVICES

03

CUSTOM API DEVELOPMENT SERVICES

India

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

Neuland has expertise in the custom development and manufacturing of new chemical entity (NCE) APIs for pharmaceutical and biotech companies. It provides an end-to-end continuum of customized NCE development services from lab to commercial supply.

Category : API Development

Sub Category : Custom Synthesis

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

CUSTOM API DEVELOPMENT SERVICES

04

API PROCESS DEVELOPMENT & OPTIMI...

India

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

Neuland's custom development capabilities include continuous process development, optimization, and validation. It has a dedicated team that continuously evaluates and improves processes using a data-driven approach and advanced technologies.

Category : API Development

Sub Category : Process Development & Optimization

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

API PROCESS DEVELOPMENT & OPTIMIZATION

05

CDMO FOR SMALL MOLECULE APIs

India

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

Neuland is a contract development and manufacturing organization that is engaged in the development of small molecules. Its API custom development services include process optimization and validation, tech transfer, and particle engineering.

Category : API Development

Sub Category : Small Molecules

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

CDMO FOR SMALL MOLECULE APIs

06

API CLINICAL SUPPLY

India

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

Neuland is a CDMO that provides full-cycle development solutions for drug substances. It is involved in the development of APIs from early phase (pre-clinical and Phase I) to late phase (Phase II and III) of clinical trials.

Category : API Development

Sub Category : Clinical Supply

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

API CLINICAL SUPPLY

07

CDMO FOR COMPLEX APIs

India

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

Neuland is a leading global API contract development and manufacturing organization (CDMO) that also offers complex active pharmaceutical ingredients. It is also involved in the production of complex niche molecules and generic APIs.

Category : API Development

Sub Category : Complex APIs

Neuland Laboratories- A dedicated 100% API provider.

Pharma Service : API & Drug Product Development

CDMO FOR COMPLEX APIs