Tag: API

The Active Pharmaceutical Ingredient (API) is the part of any drug that is active. Some drugs, such as combination therapies, have multiple active ingredients to treat different diseases. While production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries, in recent years many corporations have opted to send manufacturing overseas to cut costs. This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put into place.
All drugs are made up of two core components: the API, which is the central ingredient, and the excipient, the substance inside the drug that helps deliver the medication to your system. Excipients are inactive substances, such as mineral oil, and not chemically active.
Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. One brand might use one test, another a different one.

EMA Requests Risk Evaluation for Drugs Containing Chemically Synthesised APIs

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EMA published a statement titled “EMA advises companies on steps to take to avoid nitrosamines in human medicines (EMA/511347/2019)”. This document addresses all marketing authorisations holders for d...

FDA Called on Drug Compounders to be More Diligent with Suppliers

The US Food and Drug Administration (FDA) is calling on drug compounders to be more diligent with their suppliers to ensure that bulk active pharmaceutical ingredients they receive have been tested an...

IMCoPharma Announced Registration of API Potassium Chloride in Ukraine

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IMCoPharma informed about successful completed registration of API Potassium chloride, produced by Macco Organiques s.r.o., Czech Republic. At the same time, the API registration of Hydroxyethyl starc...

Jiuzhou Pharmaceutical to Buy Novartis API Manufacturing Facility

Zhejiang Jiuzhou Pharmaceutical has entered into a contractual commitment for the purchase of Suzhou Novartis Pharmaceutical Technology (SNPT), an API manufacturing facility in Changshu Economic Techn...

Takeda Openes First API Manufacturing Plant outside Japan

Takeda has officially opened a new manufacturing plant at its site at Grange Castle, in Dublin, Ireland. The company CEO, government ministers and industry officials together with staff and guests ...

FDA Warned Three Repackers of API for Violations of CGMP Requirements

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The U.S. Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing business as Eno...

Concept Life Sciences Opens New Facility

Concept Life Sciences, a knowledge-based provider of integrated discovery, development and analytical services, has unveiled a new, state-of-the-art clinical and niche commercial facility to support p...

Chugai Pharmaceutical to Construct a New Facility for API

Chugai Pharmaceutical Co., Ltd. (hereafter, “Chugai”) announced today the decision to construct a new manufacturing building for active pharmaceutical ingredients (APIs) for clinical studies in Fujied...

CPI Partenrs with GSK and AZ to Create New Site

GSK, AstraZeneca, and GEA join resources to create a site in the UK for developing small-scale oral solid dosage APIs. CPI is collaborating with partners GSK and AstraZeneca to establish a bespoke,...

WuXi STA Passed First GMP Inspection by MPA

STA Pharmaceutical Co., Ltd., – a subsidiary of WuXi AppTec – announces that its new drug product manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the Eu...

SP Scientific Announced First New Advanced Freeze Dryers

The LyoConstellation series allows the development of highly aggressive cycles and the mapping of the furthest reaches of theoretical design space for a formulation. SP Scientific has announced the...

FDA Commented Recalling Lots of Blood Pressure Drugs

The US agency has said a problem with the manufacturing process is the likely source of contaminants. The recall of hundreds of lots of contaminated blood pressure drugs last summer has been the su...

FDA’s Update on Impurity in API Investigation

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The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufact...

Olon Acquire Capua BioServices

Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, announced today the acquisition of Capua BioServi...

Particle Sciences Launches Nanomilling Feasibility Program

Advanced formulation techniques such as nanomilling may provide an excellent route to improved bioavailability and enhanced therapeutic effect. CDMO, Particle Sciences, a Lubrizol LifeSciences comp...

Alternative Technologies of Removing Catalysts from API

As the pharmaceutical industry has changed and grown in the last two decades, there are increasing concerns about the safe handling of active pharmaceutical ingredients (APIs)— particularly in the pro...