APIs

Nitrosamines: An Update

The linkage between nitrosamines and cancer was first postulated by William Lijinsky in 1970. Then, in 2018, N-nitroso-dimethylamine (NDMA)) was detected in an active pharmaceutical ingredient, Valsartan (an Angiotensin-II-receptor antagonist).  Finally, the FDA issued a guidance for the industry, “Control of Nitrosamine Impurities in Human Drugs”, in the fall of 2020. However, the guidelines continue to […]

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Ferring Pharmaceuticals and SK pharmteco enter into commercial gene therapy manufacturing deal

Biopharmaceutical contract manufacturer SK pharmteco commits to production, testing, and release of Ferring’s U.S. approved Adstiladrin® (nadofaragene firadenovec-vncg) The deal assures diversity of supply to meet future long-term plans for expanded availability of the gene therapy Two additional state-of-the-art manufacturing facilities for Adstiladrin® are near completion in Finland and the U.S. Saint-Prex, Switzerland and King

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Keys To Effective Method Development

Effective method development is crucial for the quality control of Active Pharmaceutical Ingredients (API) and Drug Products (DP). Thorough method development enables successful downstream method validation.  The regulatory guidance  specifies that:  Method development and validation vary by application (quantitative, qualitative, etc.).  It is phase appropriate.  The client may provide additional guidance/validation criteria.  The validation guidance

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Extractables and Leachables

Extractables and Leachables (E&L) are essential areas of concern for the pharmaceutical and food industries, specifically regarding their packaging, usage components (e.g., medical devices or syringes), and the manufacturing chain. We will examine testing of analysis of them within pharmaceutical applications. The two terms are related but distinct, each with its own analytical requirements.    Definitions of

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Nitrosamines: An Overview

Nitrosamines are organic compounds found in the human diet and other environmental outlets. Being potent carcinogens that can cause tumors in nearly all organs, they have been classified as genotoxic impurities (GTIs). There are guidelines and rulings by various regulatory organizations, including the FDA, EPA, EMA, and the IARC (International Agency for Research on Cancer).

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SK pharmteco to Showcase its Extensive APIs and CGT Capabilities at CPHI 2023

RANCHO CORDOVA, Calif. and KING OF PRUSSIA, Pa., Oct. 18, 2023 /PRNewswire/ — SK pharmteco will participate at the CPHI 2023 in Barcelona and prepare a dedicated booth at the event. As a multi-modality CDMO with expertise in small molecule active pharmaceutical ingredients (APIs) and biopharmaceuticals, SK pharmteco aims to present its business competitiveness and actively pursue business opportunities. With a dedicated booth

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SK pharmteco is a Pharma Award Finalist for CPHI Barcelona 2023

On Sept. 15, 2023, CPHI Barcelona announced the finalists for the 2023 CPHI Pharma Awards. The awards ceremony will be held on Oct. 24, 2023, the opening day of CPHI Barcelona, the world’s largest pharma event, at the Fiera Barcelona. SK pharmteco (SKPT) was honored to be among 12 finalists in the “Accelerating Innovation” category.

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