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Pharmaceutical CGMP Manufacturing Services

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The U.S. Food and Drug Administration (FDA) regulates drug manufacturing services through CGMP. As an experienced contract manufacturing organization, CD Formulation provides customers with CGMP manufacturing services from laboratory scale to commercial scale. We have advanced equipment and strict quality control systems to ensure that we can quickly bring our customers' drug products to the market.

What is Pharmaceutical CGMP Manufacturing?

Pharmaceutical CGMP manufacturing refers to the Current Good Manufacturing Practice guidelines that are established by regulatory agencies such as the U.S. Food and Drug Administration (FDA) to ensure the quality, safety, and efficacy of pharmaceutical products. These guidelines outline the minimum requirements of stringent quality control measures, documentation, and testing procedures throughout the entire manufacturing process, from raw material sourcing to the final product distribution. This includes proper facility design and maintenance, equipment calibration, personnel training, batch record keeping, and product testing for identity, strength, purity, and quality. Compliance with CGMP regulations is mandatory for pharmaceutical manufacturers to ensure the production of safe and effective medicines.

PPharmaceutical CGMP Manufacturing Services

Explore Our Pharmaceutical CGMP Manufacturing Services

CD Formulation's scientists develop innovative drug delivery systems for pharmaceutical and biotech companies. Our full range of services includes but is not limited to formulation development, process optimization, and CGMP-compliant scale-up manufacturing services.

In order to enable customers to bring drugs to the market faster, our team of scientists provides customers with CGMP manufacturing services from laboratory scale to commercial scale based on professional knowledge and experience. We have advanced equipment and facilities and an experienced team to ensure the quality and stability of our products, providing you with a more efficient way to develop new drugs and generic drugs.

CD Formulation's pilot scale-up manufacturing services cover a variety of dosage forms, including tablets, capsules, oral liquid preparations, semi-solid preparations, and complex injections.

Our state-of-the-art facilities and team of experts ensure unparalleled technical support throughout the entire production cycle of the commercial manufacturing of your pharmaceutical products and manufacture high-quality products that meet your needs.

Pharmaceutical CGMP Manufacturing Facilities

CD Formulation supports the pharmaceutical industry with state-of-the-art laboratories and state-of-the-art facilities that are FDA-inspected and approved. Importantly, our pharmaceutical CGMP manufacturing facilities support products available in a variety of dosage forms, including but not limited to tablets, capsules, semi-solid dosage forms, transdermal patches, and injectables.

  • CGMP Analytical Laboratory.
  • Clean rooms and pilot plants.
  • DEA controlled substance handling (IV).
  • Quality control laboratory.
  • CGMP-compliant production area.

Supporting CGMP Analysis Services

In addition to providing CGMP manufacturing services, we also provide CGMP-compliant analysis services for products in different dosage forms, including but not limited to:

  • Pharmaceutical formulation development.
  • Pharmaceutical analytical method development and validation
  • Standard operating procedures.
  • ICH stability testing.
  • Drug product release testing.
  • Technology transfer.

Why Choose CD Formulation for Pharmaceutical CGMP Manufacturing?

  • Comprehensive integrated CGMP supporting analysis services support the development of multiple dosage forms, including but not limited to tablets, capsules, granules, oral liquid preparations, and complex injections.
  • Always at the forefront of innovative drug delivery system development and drug analysis.
  • World-class facilities and equipment.
  • Provide integrated services from early-stage formulation development to full commercial CGMP manufacturing.
  • Professional technical support and consulting services to help customers achieve their drug development goals.
  • Reliable delivery and production schedules ensure customers can launch products on time.
  • Cost-effective and competitive prices.

CD Formulation's team of experienced scientists and engineers is able to provide customers with comprehensive support to ensure their products meet the highest standards during manufacturing. Welcome to contact us to learn more about our CGMP manufacturing services.

Please note: Our products and services are not intended to be used directly in diagnostic or therapeutic procedures.

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