NAICS Code 325412-06 - Pharmaceutical Preparation (Manufacturing)

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NAICS Code 325412-06 Description (8-Digit)

Pharmaceutical Preparation Manufacturing involves the production of medicinal and therapeutic products that are used to treat or prevent diseases. This industry includes the manufacturing of prescription and over-the-counter drugs, vitamins, and other nutritional supplements. The process of pharmaceutical preparation manufacturing involves the synthesis of active pharmaceutical ingredients (APIs) and their formulation into finished dosage forms such as tablets, capsules, and injectables. The industry is highly regulated by government agencies to ensure the safety and efficacy of the products.

Hierarchy Navigation for NAICS Code 325412-06

Tools

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

  • High-performance liquid chromatography (HPLC)
  • Gas chromatography (GC)
  • Mass spectrometry (MS)
  • Ultraviolet-visible spectroscopy (UV-Vis)
  • Fourier transform infrared spectroscopy (FTIR)
  • Nuclear magnetic resonance spectroscopy (NMR)
  • Particle size analyzer
  • Dissolution tester
  • Stability chambers
  • Lyophilizer (freeze dryer)
  • Tablet press
  • Capsule filling machine
  • Injection molding machine
  • Blister packaging machine
  • Labeling machine
  • Cleanroom equipment
  • Autoclave
  • Water purification system
  • HVAC system

Industry Examples of Pharmaceutical Preparation (Manufacturing)

Common products and services typical of NAICS Code 325412-06, illustrating the main business activities and contributions to the market.

  • Antibiotics
  • Antidepressants
  • Antihistamines
  • Antipsychotics
  • Cardiovascular drugs
  • Chemotherapy drugs
  • Hormonal contraceptives
  • Insulin
  • Pain relievers
  • Probiotics
  • Vaccines
  • Vitamins
  • Weight loss drugs

Certifications, Compliance and Licenses for NAICS Code 325412-06 - Pharmaceutical Preparation (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 pharmaceutical products are consistently produced and controlled according to quality standards. The FDA provides guidance and inspections to ensure compliance.
  • Drug Enforcement Administration (DEA) Registration: A DEA registration is required for any facility that manufactures, distributes, or dispenses controlled substances. The DEA provides guidance and inspections to ensure compliance.
  • United States Pharmacopeia (USP) Verification: USP verification is a voluntary program that verifies the quality, purity, and potency of dietary supplement finished products and ingredients. The USP provides guidance and testing to ensure compliance.
  • Occupational Safety and Health Administration (OSHA) Hazard Communication Standard: The Hazard Communication Standard requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import and provide information about them through labels and safety data sheets. OSHA provides guidance and inspections to ensure compliance.
  • Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) Certification: TSCA certification is required for any facility that manufactures, imports, processes, or distributes chemical substances in the US. The EPA provides guidance and inspections to ensure compliance.

History

A concise historical narrative of NAICS Code 325412-06 covering global milestones and recent developments within the United States.

  • The pharmaceutical industry has a long and rich history dating back to ancient times. The first recorded use of opium dates back to 3400 BC in Mesopotamia, and the ancient Egyptians used various plant extracts for medicinal purposes. In the 19th century, the isolation of active compounds from plants and the development of synthetic drugs revolutionized the industry. In the United States, the Pure Food and Drug Act of 1906 was a significant milestone in regulating the industry and ensuring the safety of pharmaceutical products. In recent years, the industry has seen notable advancements in areas such as biotechnology, personalized medicine, and gene therapy.

Future Outlook for Pharmaceutical Preparation (Manufacturing)

The anticipated future trajectory of the NAICS 325412-06 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

  • Growth Prediction: Growing

    The pharmaceutical preparation manufacturing industry in the USA is expected to grow in the coming years due to the increasing demand for drugs and medicines. The aging population and the rise in chronic diseases are the main drivers of this growth. The industry is also expected to benefit from the increasing investment in research and development, which will lead to the development of new drugs and treatments. However, the industry is also facing challenges such as increasing competition, regulatory pressures, and rising costs. Overall, the industry is expected to continue to grow in the coming years, but companies will need to adapt to the changing market conditions to remain competitive.

Industry Innovations for NAICS Code 325412-06

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

  • Artificial intelligence (AI) and machine learning (ML) are being used to develop new drugs and treatments, which can help to speed up the drug discovery process and reduce costs.
  • 3D printing technology is being used to create personalized medicines, which can be tailored to the specific needs of individual patients.
  • Gene editing technology is being used to develop new treatments for genetic diseases, such as cystic fibrosis and sickle cell anemia.
  • Nanotechnology is being used to develop new drug delivery systems, which can improve the effectiveness of drugs and reduce side effects.
  • Immunotherapy is a new approach to cancer treatment that uses the body's own immune system to fight cancer cells. This approach has shown promising results in clinical trials and is expected to become a major area of research in the coming years.

NAICS Code 325412-06 - Pharmaceutical Preparation (Manufacturing)

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