EXPRESS PHARMA DIGITAL ISSUE December 2025

 IN THIS ISSUE

COVER STORY

The Next Frontier: India's Rise In Global Healthcare

EDITOR'S NOTE

A biosimilar boost amid trade barriers

INTERVIEWS

CPHI-PMEC SPECIAL

• Overcoming oral delivery challenges: The science behind scalable enteric capsules

• India's next leap: From batch dependency to continuous quality leadership

• India’s pharma packaging: Evolving from cost to care

• E-pharmacies: Fueling India’s digital healthrevolution

• Coding and FDCE: Redefining regulatory compliance in health

• The particle puzzle

• India’s pharma packaging: Evolving from cost to care

• The invisible threat: Why packaging inks are the next major recall risk for pharma

• The constraints and innovations in the packaging of biologic drugs

• Stevanato Group outlines packaging solutions for the expanding biologics market

• SRICO strengthens collaboration with JULABO

• The next-generation of manufacturing: Smarter, faster, greener

• Delivering precision and sterility at scale

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Express Pharma Magazine November 2025

 

Will India pass the cough syrup trust test this time?

While India’s CDMOs are well positioned to capitalize on the booming GLP-1 market, the recurring episodes of contaminated cough syrups are warning flags. Loss of semifluid's key patent in March 

Alkem Foundation and IIT Bombay join hands to set up advanced research center for immuno-therapeutics and regenerative medicines

Alkem Foundation, the Corporate Social Responsibility (CSR) arm of Alkem Laboratories, and Indian Institute of Technology Bombay (“IIT Bombay”) announced a strategic collaboration to set up a first-of-its-kind research

 

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Express Pharma October 2025

IN THIS ISSUE

COVER STORY: Driving India's Innovation Edge

EDITOR'S NOTE: Turning the tariff tight spot into a sweet spot

INTERVIEW:

• Dr Gráinne McNamara, Research Integrity/Publication Ethics Manager, S. Karger AG

• Emil Alexander Byström, CEO of SpinChem AB

• Ganesh Tripathy, SVP and Global Head, Sustainability & EHS, Piramal Pharma

RESEARCH:

• Cell therapy’s next chapter: Industry embraces in-vivo innovation

TECHNOLOGY:

• AI compass: Transforming pharma commercialization

POLICY:

• Jan Vishwas Act 2025: Decriminalization and penalization of drug offences through Compounding

AYUSH:

• Unani Medicine: At crossroads of tradition and modernity

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Express Pharma September 2025

 

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Points to Consider for Cleaning Validation [PDA TR 29]

 

PDA launched the project activities related to the PCMO program in December 2008 to help implement the scientific application of the ICH Q8, Q9 and Q10 series. The PDA Board of Directors approved this program in cooperation with the Regulatory Affairs and Quality Advisory Board, and the Biotechnology Advisory Board and Science Advisory Board of PDA.

Although there are a number of acceptable pathways to address this concept, the PCMO program follows and covers the drug product lifecycle, employing the strategic theme of process robustness within the framework of the manufacturing operations. This project focuses on Pharmaceutical Quality

Systems as an enabler of Quality Risk Management and Knowledge Management.

Using the Parenteral Drug Association’s (PDA) membership expertise, the goal of the Paradigm Change in Manufacturing Operations Project is to drive the establishment of ‘best practice’ documents and /or training events in order to assist pharmaceutical manufacturers of Investigational Medicinal Products (IMPs) and commercial products in implementing the ICH guidelines on Pharmaceutical Development (ICH Q8, Q11), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).

The PCMO program facilitates communication among the experts from industry, university and regulators as well as experts from the respective ICH Expert Working Groups and Implementation Working Group. PCMO task force members also contribute to PDA conferences and workshops on the subject.

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Analysis of 23 Elements in Wastewater by U.S. EPA Method 6020B Using ICPMS-2050

For the analysis of heavy metals in wastewater, the methods of the US Environmental Protection Agency (EPA) are considered reference for analysis worldwide. The US EPA published Method 6020B to control 23 metals in environmental water using ICP-MS. ICP-MS can analyze many elements at the ppt levels and allows for simultaneous analysis by directly introducing wastewater samples. 

 In this Application News, 23 elements in wastewater were analyzed using the ICPMS-2050. Analytical samples’ spike recovery tests and long-term stability tests were performed in accordance with the quality control (QC) requirements of the EPA Method 6020B.

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British Pharmacopoeia 2025

 

New legally enforced standards, available from 1 August 2024. All European Pharmacopoeia texts included.

Updated annually, the British Pharmacopoeia (BP) is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products.

It includes approximately 4,000 monographs which are legally enforced by the Human Medicines Regulations 2012. Where a BP monograph exists, medicinal products or active pharmaceutical ingredients sold or supplied in the UK must comply with the relevant monograph.

All monographs and requirements of the European Pharmacopoeia (Ph. Eur.) are reproduced in the BP, making the BP a convenient and fully comprehensive set of standards that can be used across Europe and beyond.

New for the BP 2025

The BP 2025 supersedes the BP 2024 and becomes legally effective on 1 January 2025. This edition incorporates new monographs from both the BP and Ph. Eur. along with a significant number of revised monographs.

Monographs and BPCRS:

14 new BP monographs, 32 new Ph. Eur. monographs. Including two new monographs for Paracetamol Infusion and Paracetamol Oral Solution and a new monograph for Solifenacin Oral Suspension which is accompanied by additional information on the website. This information provides a case study demonstrating how users can scale monograph methods to reduce run times and solvent usage;

105 amended BP monographs.

All monographs from the Ph. Eur. 11th edition and Ph. Eur. supplements 11.1 to 11.5.

Ph. Eur. supplements 11.6 to 11.8 included as in-year online and download product updates.

Updated references to new BPCRS included in the BP 2025 to ensure that you remain compliant.

Ensure you get the best value access to the information you need. Choose from a range of flexible licenses and formats - including full online and offline access.

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