The manufacturing of a pharmaceutical product is a highly regulated and controlled process to ensure the safety, quality and effectiveness of the medicine.

Among its phases we can highlight:

1. Research and Development (R&D): Before a medicine is manufactured, extensive research is carried out to identify chemical compounds that may have useful pharmacological properties. This stage involves laboratory testing and preclinical studies in animals to evaluate the safety and effectiveness of the compounds.

2. Formulation Development: Once a promising compound is identified, a suitable formulation is developed to administer it, such as a tablet, capsule, solution, etc. Different formulations are tested to determine the best one in terms of stability, bioavailability and efficacy.

3. Clinical Studies: Before a drug can be approved for use in humans, it must undergo clinical trials in different phases to evaluate its safety and effectiveness. These trials involve administering the drug to human volunteers under medical supervision.

4. Regulatory Approval: Once clinical trials are completed and evidence of safety and efficacy is collected, an application for approval is submitted to the corresponding regulatory agency, such as the FDA in the United States or the EMA in Europe, among others.

5. Manufacturing: Once the drug has been approved, large-scale manufacturing begins. This process involves several stages:

a.Obtaining Raw Materials: The active ingredients and excipients necessary for the formulation of the medicine are acquired.

b.Formulation Preparation: The ingredients are mixed in the correct proportions according to the formulation developed during the R&D stage.

c.Manufacturing Process: This may include various operations such as granulation, compression, coating (in the case of tablets), encapsulation (in the case of capsules), sterilization (if necessary), among others.

d.Packaging and Labeling: Once the medication has been manufactured, it is packaged in its final form (bottles, blister packs, vials, etc.) and labeled with the information required by regulations.

6. Quality Control: Throughout the manufacturing process, extensive quality checks are carried out to ensure that the medicine meets the required standards for identity, purity, potency and stability. Such as, for example, the pharmacovigilance programs required by the Institute of Public Health of Chile (ISP) and the National Medicines Agency of Chile (ANAMED).

7. Storage and Distribution: Once manufactured and approved, the medication is stored and distributed according to applicable regulations, ensuring adequate storage conditions to maintain its quality.

It is important to note that each stage of the pharmaceutical manufacturing process is subject to strict controls and regulations to ensure the safety and effectiveness of the medicine. Additionally, manufacturing facilities must comply with specific Good Manufacturing Practice (GMP) regulations, as well as high regulatory agencies in our case.