Company profile for Aurigene Pharmaceutical Services

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

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About

Aurigene Pharmaceutical Services is a CRO/CDMO with over two decades of experience. It offers a range of services for new therapeutics, from drug discovery, clinical research and development to manufacturing APIs and formulations at commercial scales. It has development laboratories from discovery to clinical phase 3 and cGMP manufacturing sites in the UK, Mexico, the USA and India. Its technology platforms include cytotoxic APIs, carbohydrates, steroids, PEG derivatives, prostaglandins, peptides and oligonucleotides. Its large molecule discovery services include ADC, MAB, MRNA and CART-T. Aurigene's two R&D centers are USFDA inspected.

CONTACT DETAILS

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Country
Country
India
Address
Address
39-40 Hosur Road KIADB Industrial Area, Joggers Ln, Phase 2, Electronic City, ...
Telephone
Telephone
+91 7386722272
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Events

Webinars & Exhibitions

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CORPORATE CONTENT #SupplierSpotlight

    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-38979.pdf

    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-98174.pdf

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    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-11091.pdf

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    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-97302.pdf

    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-98887.pdf

    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-1653372677.pdf

    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-1653372585.pdf

    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-20994.pdf

    https://www.pharmacompass.com/pdf/party/content/aurigene-pharmaceutical-services-party-content-1653372213.pdf

DATA COMPILATION #PharmaFlow

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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. 

Impressions: 3047

https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-novo-s-parent-buys-catalent-for-us-16-5-bn-fujifilm-merck-kgaa-axplora-lonza-expand-capabilities

#PharmaFlow by PHARMACOMPASS
08 Aug 2024

NEWS #PharmaBuzz

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https://www.aurigeneservices.com/sites/default/files/2024-08/Media%20note-%20DRL-APSL%20partnership%20with%20Kainomyx.pdf

PRESS RELEASE
20 Aug 2024

https://www.aurigeneservices.com/sites/default/files/2024-07/APSL%20Edity%20Media%20note.pdf

PRESS RELEASE
01 Jul 2024

https://www.aurigeneservices.com/sites/default/files/2024-06/Genomevalley-facility-press%20release-final-3rd-June-2024.pdf

PRESS RELEASE
03 Jun 2024

https://www.aurigeneservices.com/sites/default/files/2024-04/APSL%20Vipergen%20Partnership_Media%20Note.pdf

PRESS RELEASE
19 Apr 2024

https://www.aurigeneservices.com/sites/default/files/2024-04/Aurigene-Pharma-Aurigene.AI_.pdf

PRESS RELEASE
04 Apr 2024

https://www.businesswire.com/news/home/20240403946999/en

BUSINESSWIRE
03 Apr 2024

Drugs in Development

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Details:

Kainomyx has agreed to lead the technical strategy and associated aspects for drug discovery and clinical phases, Aurigene has agreed to focus on developing cost-effective and scalable drug chemistry.


Lead Product(s): Undisclosed

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: DiscoveryProduct Type: Undisclosed

Sponsor: Kainomyx

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 20, 2024

Aurigene

01

Antibody Engineering
Not Confirmed

Lead Product(s) : Undisclosed

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Discovery

Partner/Sponsor/Collaborator : Kainomyx

Deal Size : Undisclosed

Deal Type : Agreement

Details : Kainomyx has agreed to lead the technical strategy and associated aspects for drug discovery and clinical phases, Aurigene has agreed to focus on developing cost-effective and scalable drug chemistry.

Brand Name : Undisclosed

Molecule Type : Undisclosed

Upfront Cash : Undisclosed

August 20, 2024

Aurigene

Details:

Fermenta Biotech will exclusively license its biocatalytic technology for synthesis of Molnupiravir (Molflu) and supply its enzyme Candida Antarctica B Lipase (CAL B) to Aurigene. Molnupiravir API manufactured by Aurigene will be utilised by Dr Reddy’s for its formulation.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Molflu

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Fermenta Biotech Limited

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 21, 2022

Aurigene

02

Antibody Engineering
Not Confirmed

Lead Product(s) : Molnupiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Fermenta Biotech Limited

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Details : Fermenta Biotech will exclusively license its biocatalytic technology for synthesis of Molnupiravir (Molflu) and supply its enzyme Candida Antarctica B Lipase (CAL B) to Aurigene. Molnupiravir API manufactured by Aurigene will be utilised by Dr Reddy’s...

Brand Name : Molflu

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 21, 2022

Aurigene

Details:

This next-generation adenine nucleotide translocase (ANT) inhibitor, PENAO, was shown to be safe and well-tolerated in a phase I clinical trial conducted in Australia where encouraging efficacy data was observed.


Lead Product(s): PENAO,Sirolimus

Therapeutic Area: Oncology Brand Name: PENAO

Study Phase: Phase I/ Phase IIProduct Type: Small molecule

Sponsor: PENAO Pty Ltd

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 18, 2021

Aurigene

03

Antibody Engineering
Not Confirmed

Lead Product(s) : PENAO,Sirolimus

Therapeutic Area : Oncology

Highest Development Status : Phase I/ Phase II

Partner/Sponsor/Collaborator : PENAO Pty Ltd

Deal Size : Undisclosed

Deal Type : Agreement

Details : This next-generation adenine nucleotide translocase (ANT) inhibitor, PENAO, was shown to be safe and well-tolerated in a phase I clinical trial conducted in Australia where encouraging efficacy data was observed.

Brand Name : PENAO

Molecule Type : Small molecule

Upfront Cash : Undisclosed

August 18, 2021

Aurigene

Details:

Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.


Lead Product(s): Zoliflodacin,Ceftriaxone,Azithromycin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: The Global Antibiotic Research and Development Partnership

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 17, 2020

Aurigene

04

Antibody Engineering
Not Confirmed

Lead Product(s) : Zoliflodacin,Ceftriaxone,Azithromycin

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : The Global Antibiotic Research and Development Partnership

Deal Size : Undisclosed

Deal Type : Agreement

Details : Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Undisclosed

December 17, 2020

Aurigene
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Services

Discover the service capabilities from this company

API Manufacturing

Discover their expertise for : API Manufacturing

Drug Product Manufacturing

Discover their expertise for : Drug Product Manufacturing

API & Drug Product Development

Discover their expertise for : API & Drug Product Development

API Development

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Formulation Development

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KEY SERVICES

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TOP RANKED SUPPLIER FOR:

TOP RANKED SUPPLIER FOR:

Containment of High Potency API (HPAPI)
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CDMO for Peptide API Development
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Small Molecule API Development Services
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Manufacturing of Prostaglandin Analogues
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Inspections and registrations

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FDA

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01

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-06-15

Aurigene Pharmaceutical Services

City : Hyderabad

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-06-15

Aurigene

02

FDA Audited

USA

District Decision : No Action Indicated

Inspection End Date : 2019-03-21

Aurigene Pharmaceutical Services

City : Hyderabad

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2019-03-21

Aurigene
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