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Despite global volatility India’s pharma exports continue to demonstrate steady resilience

Express Pharma

The PLI scheme has definitely been a turning point for India’s pharma manufacturing, especially in APIs and KSMs. We’ve emphasized a cautious, wait-and-watch approach during periods of uncertainty, while simultaneously facilitating communication between industry stakeholders and the government.

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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 2

Express Pharma

Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. PDA TR 22, ISO 14644, ICH Q9, Q10) adequately supported by the relevant data set.

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Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

So much smaller, much leaner and definitely more startup mentality. And we’re trying to get on the line with a pharmacy and they’re working on getting a license in a certain state, so understanding pharmacy law, my MPJE definitely came in handy. So there’s still definitely a lot of PharmD in there.

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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

Even well-intentioned policies can create access disparities if communication and operational support are lacking. It is unclear how CMS will communicate this determination or whether stakeholders will be notified and invited to contribute evidence before a new price is set.

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Towards a healthier, more equitable and innovative Indian healthcare sector

Express Pharma

The increased funding for Ayushman Bharat is a definite step towards moving closer to universal health coverage, and such coverage should include modern treatments such as TAVI/ TAVR involving valve implantation or replacement.

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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 3

Express Pharma

Glossary of key terms and definitions Sterility Assurance Level (SAL): The probability of a single unit being non-sterile after it has been subjected to a validated sterilisation or aseptic process. Warning Letter: A formal communication from the FDA indicating significant GMP violations that may lead to enforcement action.

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Reinventing Transplant Care: From Inpatient Tradition to Outpatient Innovation

Pharmacy Times

That is something we have definitely taken from transplant and shared with our other bispecific programs—especially now that we do bispecifics in solid tumors. Pharmacy Times : How does the team ensure smooth transitions from inpatient to outpatient transplant care, particularly regarding medication management?