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News about Manufacturing
FDA Introduces Pilot Scheme to Simplify Nicotine Pouch Manufacturers' Research Obligations
The U.S. Food and Drug Administration (FDA) is set to ease research requirements for manufacturers of nicotine pouches under a new pilot scheme, according to internal meeting transcripts. This marks the clearest indication yet of a more relaxed approach to smoking alternatives.
Manufacturing | 22/09/2025 | By Darshana | 228
Lupin's Nagpur Injectable Facility Receives Six Observations in USFDA Inspection
Lupin’s injectable facility in Nagpur has received six observations from the US Food and Drug Administration (USFDA), following an inspection conducted between the 8th and 16th of September 2025.
Manufacturing | 19/09/2025 | By Darshana | 331
Enzene, Aurobindo and Biocon Boost US Manufacturing with Major New Jersey Expansions
This month, three leading Indian firms — Enzene Biosciences, Aurobindo Pharma, and Biocon — have inaugurated major facilities in New Jersey, underscoring a growing trend of onshore investment by Indian pharma companies.
Manufacturing | 18/09/2025 | By Dineshwori | 297
GSK to Invest USD 30 Billion in US R&D and Supply Chain Over Next 5 Years
GSK has announced plans to invest USD 30 billion across the United States over the next five years to strengthen its R&D, drug discovery, development, and clinical trial activity.
Manufacturing | 17/09/2025 | By Dineshwori | 175
Piramal Pharma Solutions, the CDMO arm of Piramal Pharma Ltd., has installed a state-of-the-art Korsch XM-12 bilayer tablet press at its Morpeth, UK facility to enhance precision, efficiency, and flexibility in oral solid manufacturing.
Manufacturing | 16/09/2025 | By Mrinmoy Dey | 156
The partnership aims to speed up market entry for biopharma firms by combining Mycenax's biologics expertise with Spera Pharma’s high-potent fill-finish capabilities, offering an integrated, cost-effective ADC development platform.
Manufacturing | 15/09/2025 | By Dineshwori | 176
Aenova Expands Microbiology QC Lab at Latina Site to Boost Sterile Manufacturing
Aenova has announced a major expansion of its microbiology quality control (QC) laboratory at its Latina site in Italy to attract new customers seeking expertise in sterile manufacturing.
Manufacturing | 13/09/2025 | By Dineshwori | 287
New GST Rates: DCGI Orders Medical Device Makers to Update MRP Within 3 Months
The Central Drugs Standard Control Organization (CDSCO) has directed manufacturers and importers of Class C and D medical devices to update their inventories with revised MRP reflecting the newly reduced 5 percent Goods and Services Tax (GST).
Manufacturing | 12/09/2025 | By Dineshwori | 580
Implantica Expands Manufacturing of RefluxStop Device to Meet Anticipated US Demand
Implantica AG, a medtech company pioneering advanced technology inside the body, has unveiled its strategy to manufacture 10,000 RefluxStop devices in preparation for substantial demand from the United States, following FDA pre-market approval.
Manufacturing | 12/09/2025 | By Darshana | 140
MMT Unveils Glebar P5K Gauging System
MMT's Glebar P5K Gauging System measures at a speed of 16,000 diameter readings per second, delivering 12 times the measurement of any currently available system on the market.
Manufacturing | 11/09/2025 | By Dineshwori
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