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A New Chemical Entity (NCE) minus 1 filing, also known as a paragraph IV filing, is a type of application submitted to the U.S. Food and Drug Administration (FDA) for a new drug that represents a slight modification of an existing approved drug. The term "minus 1" indicates that the NCE is only one small change away from…

A New Chemical Entity (NCE) refers to a compound identified during the drug discovery process in the pharmaceutical industry. This compound has a novel structure, possibly a new chemical class that has been discovered by the innovator. NCE also implies that such a compound has never been approved for medical use by any regulatory authority worldwide. The…

A tablet is a compressed solid dosage form that contains medicinal substances, with or without excipients. According to the Indian Pharmacopoeia, pharmaceutical tablets are solid, flat, or biconvex units created by compressing drugs or a mixture of drugs, with or without diluents. These tablets come in various shapes, sizes, and weights, which depend on the quantity of active…

An expectorant is a cough syrup as commonly known. Expectorant is a medication that aids in loosening and expelling mucus from the respiratory tract. It functions by boosting saliva production and thinning mucus, which facilitates easier coughing and clearing of the airways. Expectorants are used to treat the symptoms of respiratory tract infections, such as the common cold,…

Many medications are taken orally, available in various forms such as solid tablets, capsules, chewable tablets, or orally disintegrating tablets meant to be swallowed whole or dissolved in the mouth. Additionally, medications can come in liquid forms like drops, syrups, or solutions. They are also available as powders and granules to be mixed with water…

The field of medicine is continuously advancing, with new discoveries and innovations emerging daily. A fundamental aspect of medical treatment that has remained essential over time is the practice of injections. Injections are crucial for administering lifesaving treatments directly into our blood, thereby making the medicinal component available to act instantly.  In the medical field, injections…

Vaccines are composed of various components that work together to stimulate the immune system to recognize and fight specific pathogens. The primary components of vaccines include: Antigens: These are the main active ingredients in vaccines. They can be parts of the virus or bacteria (such as proteins or sugars) or the whole pathogen in a weakened…

The capsule is an oral dosage form and is designed in a cylindrical shape that contains the medicine, and it is manufactured to be easy to swallow. Pharmaceutical capsules are increasingly becoming a preferred alternative to tablets. A capsule can hold powders, granules, pellets, liquids that are otherwise nonpalatable and cannot be provided in a…

Healthcare management requires several different types of product range of which medical instruments and consumables are very important. These products are typically designed and manufactured in a clean environment to minimize contamination from viable organisms. These products are often intended for procedures or situations where the risk of infection is low. Common types of non-sterilized medical…

Sterilization is a process that removes, kills, or deactivates all forms of viable life of various germs. It is related to the term "sterile," which means completely free of viable microorganisms or viruses that could potentially reproduce. Products that require sterilization are often treated using chemicals (gas), heat, or radiation methods. This process eliminates any…

Oral dosage forms are pharmaceutical formulations designed for administration by mouth, offering various options to cater to different age groups and patient needs and drug properties. Tablets are solid, compressed forms containing active ingredients and excipients, ideal for precise dosing and stability. Capsules encase the drug in a gelatin or non-gelatin shell, facilitating easier swallowing and…

Every pharmaceutical product needs to be free from viable bacteria, yeast and fungi. The principles of GMP therefore mandate manufacturing hubs to be clean and free from such contaminants.  The clean room concept is based on maintaining high hygiene areas that free from such contaminants. Topical and external application preparations do not require to be…