Express Pharma

MARCH 20, 2024

Material Sourcing (Strategic & Plant), Global Supply Chain Management, Dr Reddy’s Laboratories (Moderator) + Chandi Prasad Ravipati, Head-Packaging Development, Aurobindo Pharma + Santanu Chowdhury, Sr GM – Packaging Development, Sun Pharmaceutical Industries + Prabir Das, Pharma Expert + Dr Sajeev Chandran, VP – Pharma R&D, (..)

Packaging 52

Packaging Labelling 52

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.

Packaging 95

Packaging Customer Service Labelling Dosage 95

Express Pharma

MARCH 12, 2025

It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database. Private label distributors, such as Walmart, are an exception to this rule, but their products still indicate India as the country of origin.

Generic Medicine 66

Generic Medicine Process Improvement Dosage Pharmaceutical Manufacturing 66

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

Packaging 105

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.

Documentation 98

Documentation Method Validation Packaging Labelling 98

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.

Biosimilars 130

Biosimilars Labelling Drug Pricing Packaging 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.

Labelling 130

Labelling Packaging Controlled Substances 130

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.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

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

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

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.

Labelling 59

Labelling Packaging Documentation 59

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.

Labelling 52

Labelling Compounding Packaging Hospitals 52

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.

Packaging 52

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).

Immunity 40

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.

Biosimilars 40

Biosimilars Packaging Labelling 40

ID Stewardship

JANUARY 13, 2025

BCIDP UNDER CONSTRUCTION Article PostedXXX Sulopenem etzadroxil and probenecid (Orlynvah) was recently approved in October 2024 for the treatment of uncomplicated urinary tract infections (uUTI) caused by Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis. 2024 Nov 2:S1198-743X(24)00507- X. Orlynvah [package insert].

Packaging 52

Packaging Labelling 52

RX Note

DECEMBER 25, 2024

Strategies for sodium reduction include Make reading food labels a habit. meats, fruits and vegetables) rather than their packaged counterparts. WebMD - Celtic Salt: What You Should Know, 2024 Should you use iodized salt?, When available, buy low-sodium, reduced-sodium or no-sodium versions of foods (e.g.

Community Pharmacies 40

Community Pharmacies Packaging Labelling Diabetes 40

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 7] A recent report from 2024 found that fluoride exposure is associated with lower IQ in children, which has brought the issue of fluoridation front and center again (the U.S.

Health and Personal Care Stores 60

Health and Personal Care Stores Labelling Immunity Immunization 60

European Pharmaceutical Review

JANUARY 20, 2025

Sustainable practises in healthcare benefit everyone ePI represents a step towards reducing the environmental footprint of pharmaceutical supply chains by eliminating paper leaflets and reducing packaging size. Several AstraZeneca markets have already demonstrated the benefits a transition to ePI could bring. Cited 2024Aug]. Data on File.

Communication 52

Communication Packaging Labelling Hospitals 52