Calcipotriol Anhydrous vs Monohydrate: Which Form Should Your Formulation Team Source?
By Team DK Pharmachem
Calcipotriol Anhydrous vs Monohydrate: Which Form Should Your Formulation Team Source? Table of Contents A purchase order for “Calcipotriol” looks simple. It is not. The same molecule is sold in two solid forms, anhydrous and monohydrate, and the choice affects potency calculations, stability behaviour, regulatory filings and supplier shortlisting. Teams that treat the two forms
Read MoreHow In-House Analytical Validations Reduce Supply Chain Risks in Contract Manufacturing
By Team DK Pharmachem
How In-House Analytical Validations Reduce Supply Chain Risks in Contract Manufacturing Table of Contents In contract manufacturing, supply chain risks can come from more than raw material shortages or production delays. Testing and quality activities can also affect timelines when important analytical work depends on external laboratories. For pharmaceutical manufacturers, having analytical capabilities in-house can
Read MoreDMF vs CEP vs USDMF: A Guide for US Pharma Sourcing Teams Before Placing a Bulk API Order from India
By Team DK Pharmachem
DMF vs CEP vs USDMF: A Guide for US Pharma Sourcing Teams Before Placing a Bulk API Order from India Table of Contents If you’re a sourcing or regulatory affairs professional at a US pharmaceutical company evaluating an Indian bulk API supplier, you’ve likely run into three acronyms that get used loosely, and sometimes incorrectly:
Read MoreHow US Generic Drug Makers Can Qualify Indian API Manufacturers: A Pharma Sourcing Checklist
By Team DK Pharmachem
How US Generic Drug Makers Can Qualify Indian API Manufacturers: A Pharma Sourcing Checklist Table of Contents For a US generic drug maker, the decision to bring on a new Active Pharmaceutical Ingredient (API) supplier is rarely just a procurement exercise. It is a regulatory, quality, and business continuity decision that will affect an Abbreviated
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