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NAICS Code 325412-02 Description (8-Digit)

The Drug (Manufacturing) industry is a subdivision of the Pharmaceutical Preparation Manufacturing industry, which involves the production of drugs for human and animal use. This industry includes the manufacturing of prescription and over-the-counter drugs, as well as biologics, vaccines, and other pharmaceutical products. The process of drug manufacturing involves a range of activities, including research and development, clinical trials, formulation, production, packaging, and distribution.

Hierarchy Navigation for NAICS Code 325412-02

Tools

Tools commonly used in the Drug (Manufacturing) industry for day-to-day tasks and operations.

  • High-performance liquid chromatography (HPLC)
  • Gas chromatography (GC)
  • Mass spectrometry (MS)
  • Nuclear magnetic resonance (NMR) spectroscopy
  • Infrared (IR) spectroscopy
  • Ultraviolet-visible (UV-Vis) spectroscopy
  • Particle size analyzers
  • Dissolution testers
  • Stability chambers
  • Lyophilizers
  • Autoclaves
  • Fermenters
  • Mixers
  • Granulators
  • Tablet presses
  • Capsule fillers
  • Coating machines
  • Labeling machines
  • Blister packaging machines

Industry Examples of Drug (Manufacturing)

Common products and services typical of NAICS Code 325412-02, illustrating the main business activities and contributions to the market.

  • Antibiotics (Manufacturing)
  • Antidepressants (Manufacturing)
  • Antihistamines (Manufacturing)
  • Antipsychotics (Manufacturing)
  • Blood products (Manufacturing)
  • Chemotherapy drugs (Manufacturing)
  • Hormones (Manufacturing)
  • Insulin (Manufacturing)
  • Pain relievers (Manufacturing)
  • Vaccines (Manufacturing)

Certifications, Compliance and Licenses for NAICS Code 325412-02 - Drug (Manufacturing)

The specific certifications, permits, licenses, and regulatory compliance requirements within the United States for this industry.

  • Current Good Manufacturing Practice (Cgmp): cGMP is a set of regulations enforced by the FDA to ensure that drugs are consistently produced and controlled according to quality standards. The FDA provides cGMP certification to drug manufacturers after an inspection of their facilities and processes.
  • Drug Enforcement Administration (DEA) Registration: The DEA requires drug manufacturers to register with them to manufacture controlled substances. The registration process involves a background check and an inspection of the facility.
  • Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS): The HCS requires drug manufacturers to provide information about hazardous chemicals used in their facilities to their employees and customers. Compliance with the HCS involves labeling, safety data sheets, and employee training.
  • Environmental Protection Agency (EPA) Hazardous Waste Generator: Drug manufacturers generate hazardous waste during their manufacturing processes. The EPA requires them to obtain a hazardous waste generator identification number and comply with regulations for the storage, transportation, and disposal of hazardous waste.
  • International Organization for Standardization (ISO) 9001: ISO 9001 is a quality management system standard that can be applied to any industry, including drug manufacturing. Compliance with ISO 9001 involves a certification process that verifies that a company's quality management system meets the standard's requirements.

History

A concise historical narrative of NAICS Code 325412-02 covering global milestones and recent developments within the United States.

  • The "Drug (Manufacturing)" industry has a long and rich history dating back to ancient times. The first recorded use of drugs dates back to 2600 BC in China, where the use of herbal remedies was common. In the 19th century, the development of synthetic drugs revolutionized the industry, and the first modern drug, aspirin, was introduced in 1899. In the United States, the Pure Food and Drug Act of 1906 was a significant milestone in the industry, as it required drugs to be labeled with their ingredients and dosage. In the 20th century, the industry continued to grow, with the development of antibiotics, vaccines, and other life-saving drugs. In recent years, the industry has faced challenges such as rising drug prices and the opioid epidemic, but it continues to be a vital part of the healthcare system. Recent history in the United States has been marked by a focus on innovation and research. The industry has seen significant investment in new technologies such as gene therapy and personalized medicine. The FDA has also streamlined the drug approval process, allowing for faster development and approval of new drugs. However, the industry has also faced criticism for high drug prices and the role of pharmaceutical companies in the opioid epidemic. Overall, the "Drug (Manufacturing)" industry in the United States has a complex and evolving history, with both successes and challenges.

Future Outlook for Drug (Manufacturing)

The anticipated future trajectory of the NAICS 325412-02 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

  • Growth Prediction: Growing

    The future outlook for the Drug (Manufacturing) industry in the USA is positive. The industry is expected to grow due to the increasing demand for drugs and the aging population. The industry is also expected to benefit from the increasing prevalence of chronic diseases and the growing need for personalized medicine. The industry is also expected to benefit from the increasing investment in research and development, which is expected to lead to the development of new drugs and therapies. However, the industry is also expected to face challenges such as increasing competition, regulatory hurdles, and rising costs. Overall, the industry is expected to continue to grow in the coming years, driven by the increasing demand for drugs and the growing need for innovative therapies.

Industry Innovations for NAICS Code 325412-02

Recent groundbreaking advancements and milestones in the Drug (Manufacturing) industry, reflecting notable innovations that have reshaped its landscape.

  • CRISPR Gene Editing Technology: This technology has the potential to revolutionize drug development by allowing scientists to edit genes and create new treatments for diseases.
  • 3D Printing Of Drugs: This technology allows for the creation of personalized drugs that are tailored to the specific needs of individual patients.
  • Immunotherapy: This innovative treatment approach uses the body's own immune system to fight cancer and other diseases.
  • Precision Medicine: This approach to medicine takes into account a patient's genetic makeup, lifestyle, and environment to create personalized treatment plans.
  • Artificial Intelligence: AI is being used to analyze large amounts of data and identify new drug targets and treatment approaches.
  • MRNA Vaccines: These vaccines use a new technology that allows for the rapid development of vaccines for new diseases.
  • Gene Therapies: These therapies use genes to treat or cure diseases by replacing or modifying defective genes.
  • Biosimilars: These are generic versions of biologic drugs that are similar in quality, safety, and efficacy to the original drug.
  • Continuous Manufacturing: This innovative approach to drug manufacturing allows for the continuous production of drugs, which can lead to cost savings and increased efficiency.
  • Digital Therapeutics: These are software-based treatments that use digital technology to treat diseases and improve patient outcomes.

NAICS Code 325412-02 - Drug (Manufacturing)

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