NAICS Code 325412-05 - Medicines-Patent (Manufacturing)

Marketing Level - NAICS 8-Digit

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NAICS Code 325412-05 Description (8-Digit)

Medicines-Patent (Manufacturing) is a subdivision of the Pharmaceutical Preparation Manufacturing industry that involves the production of patented medicines. These are medications that have been granted a patent by the government, giving the manufacturer exclusive rights to produce and sell the drug for a certain period of time. The manufacturing process for these medicines involves a range of complex procedures to ensure the drug is produced to the highest quality standards and meets all regulatory requirements.

Hierarchy Navigation for NAICS Code 325412-05

Tools

Tools commonly used in the Medicines-Patent (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
  • Lyophilizers
  • Microfluidizers
  • Homogenizers
  • Autoclaves
  • Fermenters
  • Centrifuges
  • Freeze dryers
  • Tablet presses
  • Capsule fillers
  • Coating machines
  • Blister packaging machines
  • Labeling machines
  • Sterilization equipment
  • Cleanrooms
  • HVAC systems

Industry Examples of Medicines-Patent (Manufacturing)

Common products and services typical of NAICS Code 325412-05, illustrating the main business activities and contributions to the market.

  • Anti-inflammatory drugs
  • Antidepressants
  • Antipsychotics
  • Blood thinners
  • Chemotherapy drugs
  • Diabetes medications
  • Hormone replacement therapy drugs
  • Immunosuppressants
  • Painkillers
  • Vaccines

Certifications, Compliance and Licenses for NAICS Code 325412-05 - Medicines-Patent (Manufacturing)

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

  • Good Manufacturing Practice (GMP): GMP 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 GMP certification to pharmaceutical manufacturers in the US.
  • Drug Enforcement Administration (DEA) Registration: The DEA registration is required for manufacturers of controlled substances. The DEA is responsible for enforcing controlled substance laws and regulations in the US.
  • United States Pharmacopeia (USP) Verification: USP is a non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements. USP verification is a voluntary program that verifies the quality of pharmaceutical products.
  • Occupational Safety and Health Administration (OSHA) Compliance: OSHA is a federal agency that sets and enforces safety and health standards in the workplace. Pharmaceutical manufacturers must comply with OSHA regulations to ensure the safety of their employees.
  • Environmental Protection Agency (EPA) Compliance: The EPA is a federal agency that sets and enforces environmental regulations in the US. Pharmaceutical manufacturers must comply with EPA regulations to ensure that their manufacturing processes do not harm the environment.

History

A concise historical narrative of NAICS Code 325412-05 covering global milestones and recent developments within the United States.

  • The "Medicines-Patent (Manufacturing)" industry has a long and rich history worldwide. One of the earliest examples of patent medicine was the "Elixir of Vitriol," which was a mixture of sulfuric acid, alcohol, and herbs. In the United States, the industry began to take shape in the late 19th century, with the rise of companies like Pfizer and Eli Lilly. These companies were responsible for many of the early breakthroughs in the industry, including the development of penicillin and other antibiotics. In recent years, the industry has continued to evolve, with the rise of biotech companies and the increasing importance of personalized medicine. In the United States, the "Medicines-Patent (Manufacturing)" industry has undergone significant changes in recent years. One of the most notable developments has been the rise of generic drugs, which now account for a significant portion of the market. Another important trend has been the increasing focus on research and development, with many companies investing heavily in new drug discovery. Additionally, the industry has faced significant regulatory challenges, including increased scrutiny from the FDA and other government agencies. Despite these challenges, the industry remains a vital part of the US economy, with many companies continuing to innovate and develop new treatments for a wide range of diseases and conditions.

Future Outlook for Medicines-Patent (Manufacturing)

The anticipated future trajectory of the NAICS 325412-05 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

  • Growth Prediction: Stable

    The future outlook for the Medicines-Patent (Manufacturing) industry in the USA is positive. The industry is expected to grow due to the increasing demand for innovative and effective medicines. The aging population and the rise in chronic diseases are also expected to drive the growth of the industry. The industry is also expected to benefit from the increasing investment in research and development by pharmaceutical companies. However, the industry is also facing challenges such as increasing competition, regulatory hurdles, and rising costs of research and development. Overall, the industry is expected to grow steadily in the coming years.

Industry Innovations for NAICS Code 325412-05

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

  • Pfizer's COVID-19 Vaccine: Pfizer's COVID-19 vaccine is a major milestone in the Medicines-Patent (Manufacturing) industry. The vaccine has been shown to be highly effective in preventing COVID-19 and has been approved for emergency use in many countries.
  • Novartis' Kymriah: Kymriah is a breakthrough CAR-T cell therapy that has been approved for the treatment of certain types of cancer. The therapy involves reprogramming a patient's own immune cells to attack cancer cells.
  • Merck's Keytruda: Keytruda is a revolutionary cancer immunotherapy that has been approved for the treatment of many types of cancer. The drug works by blocking a protein that helps cancer cells evade the immune system.
  • Roche's Hemlibra: Hemlibra is a breakthrough treatment for hemophilia A that has been shown to reduce bleeding episodes in patients. The drug works by mimicking the function of a missing protein in the blood.
  • Gilead's Biktarvy: Biktarvy is a highly effective treatment for HIV that has been approved by the FDA. The drug is a combination of three antiretroviral drugs and has been shown to be highly effective in suppressing the virus.

NAICS Code 325412-05 - Medicines-Patent (Manufacturing)

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