Aarti Pharmalabs | GDUFA | Inspections & Registrations

Business Responsibility and Sustainability Report

15 Jul 2024

// PRESS RELEASE

Aarti Pharmalabs Annual Report 2023-24

15 Jul 2024

// PRESS RELEASE

Aarti Pharmalabs jumps after Q4 PAT climbs 52% YoY to Rs 65 cr

14 May 2024

// BUSINESS-STANDARD

DATA COMPILATION
#PharmaFlow

Contact Supplier

Website

CPhI India 2024

Booth #2.F08

Book a meeting

envelop Contact Supplier

DIGITAL CONTENT

8 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 43 NEWS #PharmaBuzz

media
8 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
43 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

85 All APIs, 43 USDMF, 22 CEP/COS, 4 JDMF, 44 EU WC, 15 KDMF, 33 NDC API, 68 Listed APIs

85 All APIs
43 USDMF
22 CEP/COS
4 JDMF
44 EU WC
15 KDMF
33 NDC API
68 Listed APIs

INTERMEDIATES

95 All Intermediates

95 All Intermediates

KEY PRODUCTS

Apalutamide, Enalapril Maleate, Enzalutamide, Ibrutinib, Mirabegron, Nilotinib

Apalutamide
Enalapril Maleate
Enzalutamide
Ibrutinib
Mirabegron
Nilotinib

SERVICES

API Manufacturing, API & Drug Product Development

pharmaServices
API Manufacturing
API & Drug Product Development
- 5 API Development

INSPECTIONS & REGISTRATIONS

5 FDA, 1 EDQM, 1 WHO-GMP, 1 GDUFA

inspections
5 FDA
1 EDQM
1 WHO-GMP
1 GDUFA

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

About

Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.

Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer

CPhI India 2024CPhI India 2024

Industry Trade Show

Booth #2.F08

26-28 November, 2024

India Expo Centre, Greater Noida
IPEX IndonesiaIPEX Indonesia

Industry Trade Show

Not Confirmed

09-12 October, 2024

Jakarta, Indonesia
AllPack Indonesia 2024AllPack Indonesia 2024

Industry Trade Show

Not Confirmed

09-12 October, 2024

JIExpo Kemayoran, Jakarta - Indonesia

CONTACT DETAILS

Click the arrow to open the dropdown

Country

India

Address

Embassy Park 247, Tower C, 401, 4th Floor, LBS Marg, Vikhroli (W), Mumbai

Telephone

+91 2269436100

api@aartipharmalabs.com

Website

https://www.aartipharmalabs.com/

https://www.linkedin.com/company/aarti-pharmalabs-limited

YouTube

https://www.youtube.com/@aartipharmalabs-sj3zo

Digital content

Explore the latest content creation from this company

CORPORATE CONTENT #SupplierSpotlight

Product List 2023

Open PDF

Upload

Corporate Presentation

Open PDF

Upload

API Product List 2023

Open PDF

Upload

Intermediates Product List 2023

GMP Certificate 2019

Corporate Video

Dedicated Hydrogenation Block

New R&D Centre

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.