Express Pharma

MAY 7, 2024

Steriline, the European manufacturer of standard and robotic lines for the aseptic processing of injectable drugs, will exhibit at Achema 2024, from June 10 to 14.It The market for pharmaceutical packaging will grow by 8.24 per cent worldwide and the market for pharmaceutical packaging machines by 7.5 in the EU).

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Packaging Pharmaceutical Manufacturing Labelling 105

European Pharmaceutical Review

JUNE 4, 2024

Meeting the Divisions at ACHEMA 2024 IMA Active The ideal partner for each solid dose processing phase: granulation, tableting, capsule filling and banding, weight checking, coating, handling and washing. customers will have the opportunity to experience first hand various digital solutions aimed at reducing maintenance costs and downtime.

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Packaging Customer Service Labelling Dosage 95

Express Pharma

JUNE 4, 2024

The premier expo opened its door to over 200 exhibitors showcasing more than 1000 brands offering insights into Machinery & Packaging, Lab Analytical & Cleanroom, and Pharma Ingredients segments The 10th edition of PharmaLytica, organised by Informa Markets in India, commenced at HITEX, Hyderabad. We exported USD 27.8

Packaging 105

Packaging Biosimilars Vaccines Labelling 105

GMPSOP

MARCH 30, 2024

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Different products should not be packaged in proximity unless physical segregation exists. Please look at the labeling operation in the picture below.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Express Pharma

JUNE 28, 2024

With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. We exported $ 27.8

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Packaging Biosimilars Labelling Vaccines 105

European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

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Documentation Method Validation Packaging Labelling 98

ID Stewardship

OCTOBER 14, 2024

BCPS, BCIDP Article Posted October 2024, First Released in the October 2024 IDstewardship Newsletter 1. Read all about this in the product label here. More information on ganciclovir in the label here. The process is detailed in the package insert here. Authored By: Timothy P. Gauthier, Pharm.D., Well, maybe not.

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Compounding Labelling Packaging Hospitals 52

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

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Labelling Packaging Documentation 57

Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. They may be submitted here and are due by January 5, 2024 Read the full statement here. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber.

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Biosimilars Labelling Drug Pricing Packaging 130

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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Biosimilars Packaging Labelling Drug Development 130

LifeProNow

MARCH 10, 2023

billion as part of the president’s fiscal year (FY) 2024 budget. The FY 2024 request, which covers the period from Oct. 30, 2024, includes new efforts for high priority program areas. million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight.

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Labelling Packaging Controlled Substances 130

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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Packaging Labelling 52

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

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Immunity Immunization Vaccines Health and Personal Care Stores 40

PharmaShots

MARCH 1, 2023

osteoporosis in postmenopausal women and men with high fractures risk, treatment-induced bone loss The submission was based on the comprehensive analytical and clinical data package, incl.

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Biosimilars Packaging Labelling 40