News about Manufacturing

WuXi Biologics' Five Manufacturing Facilities Clear US FDA Pre-License Inspection Without Observations

WuXi Biologics' Five Manufacturing Facilities Clear US FDA Pre-License Inspection Without Observations

As of late 2024, WuXi Biologics has successfully passed 42 regulatory inspections, including 22 by the EU EMA and the FDA. Additionally, the company has received 97 license approvals from regulatory agencies around the world.

Manufacturing | 23/07/2025 | By Darshana 206

Cipla Backs iCaltech to Accelerate Innovation in Medical Device Manufacturing

Cipla Backs iCaltech to Accelerate Innovation in Medical Device Manufacturing

iCaltech, an ISO13485-certified firm, specialises in the development and commercialisation of regulatory-approved diagnostic equipment, particularly for respiratory care. The company designs, manufactures, and markets innovative medical technologies.

Manufacturing | 22/07/2025 | By Darshana 272

Aptar Pharma Acquires Mod3 Pharma's Clinical Manufacturing Unit to Boost Early-Stage Drug Delivery Capabilities

Aptar Pharma Acquires Mod3 Pharma's Clinical Manufacturing Unit to Boost Early-Stage Drug Delivery Capabilities

This acquisition builds on a successful partnership between the two companies, helping meet a critical market gap in early-phase clinical trial supply. The facility in Boonton, New Jersey—now part of Aptar’s operations—is FDA-inspected and houses cGMP cleanrooms, suites for high-potency APIs and biologics, and advanced fill-finish technologies.

Manufacturing | 16/07/2025 | By Darshana 510

Burkert and Siemens Strengthen Valve Island Integration for Process Manufacturing

Burkert and Siemens Strengthen Valve Island Integration for Process Manufacturing

The agreement ensures full compatibility between Bürkert’s advanced valve island technology and Siemens’ SIMATIC ecosystem, streamlining automation in highly regulated environments such as pharmaceutical, biotech, and food & beverage manufacturing.

Manufacturing | 14/07/2025 | By Darshana 281

HP Government Seeks API Investment as Bulk Drug Park Enters Tender Phase

HP Government Seeks API Investment as Bulk Drug Park Enters Tender Phase

With tenders already floated for key infrastructure components, the state is inviting pharmaceutical companies—particularly those involved in active pharmaceutical ingredients (APIs) and key starting materials (KSMs)—to express interest. Plot allotments, coupled with attractive incentive packages, are expected to commence shortly.

Manufacturing | 14/07/2025 | By Darshana 915

BDMAI to Launch Exclusive E-Marketing Portal for Indian Bulk Drug Industry

BDMAI to Launch Exclusive E-Marketing Portal for Indian Bulk Drug Industry

Aimed particularly at supporting small and medium enterprises (SMEs), the portal will enable bulk drug manufacturers to showcase their products and services digitally, thereby expanding their market reach through digitalisation.

Manufacturing | 14/07/2025 | By Darshana 336

Sentio BioSciences to Invest USD 10.6 Million in Missouri Manufacturing Expansion

Sentio BioSciences to Invest USD 10.6 Million in Missouri Manufacturing Expansion

The project will also introduce new infrastructure to support the company’s growing contract development and manufacturing organisation (CDMO) services. Construction is scheduled for completion in 2026.

Manufacturing | 11/07/2025 | By Darshana 141

Emcure's Sanand Manufacturing Facility Clears US FDA Inspection With Zero Observations

Emcure's Sanand Manufacturing Facility Clears US FDA Inspection With Zero Observations

The PAI, held between June 30 and July 8, 2025, is a critical regulatory step for pharmaceutical companies seeking approval to launch new products in the US. It assesses a manufacturing site’s adherence to Good Manufacturing Practices (GMP) and overall readiness to support a pending New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Manufacturing | 10/07/2025 | By Darshana 666

Deadline for Submitting PLI Applications For KSM, API Manufacturing Extended Again

Deadline for Submitting PLI Applications For KSM, API Manufacturing Extended Again

The Department of Pharmaceuticals (DoP) has once again extended the deadline for submitting applications for the eligible products under the "Production Linked Incentive Scheme for Promotion of Domestic Manufacturing of Critical Key Starting Materials (KSMs)/Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in India.”

Manufacturing | 09/07/2025 | By Dineshwori 741

Esaote Showcases 'Vet-MR Grande ELITE' ECVS 2025

Esaote Showcases 'Vet-MR Grande ELITE' ECVS 2025

Esaote presents the new Vet-MR Grande ELITE, the next generation of veterinary MRI at ECVS 2025.

Manufacturing | 04/07/2025 | By Manvi 100

 
 

 

 

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