The Highest Medical-Grade Oral Semaglutide, Meticulously Engineered for Your Patients

Our Guaranteed Supply of USA-Made Weight Loss Medication

Unlike other semaglutide brands, Optimal Scripts manufactures the single most consistent supply of medical-grade GLP-1 medications available anywhere. Elsewhere, you may have to wait months to get the first dosages of Rybelsus® or Wegovy®, or their generic alternatives. Leveraging our streamlined ordering system, we not only simplify the prescription process for physicians, but also expedite delivery, ensuring that your patients receive their medication at their doorstep in as few as two days. Our guaranteed supply of thoroughly tested semaglutide, made by fully licensed U.S. compounding pharmacies and facilities, eliminates both the wait and the hassle.

Your Trusted Pharmaceutical Partner

Optimal Scripts is a leading pharmaceutical brand committed to quality, safety and innovation. Our facilities are fully automated, adhering to CGMP (Current Good Manufacturing Practices) standards.

Direct API Sourcing

We source APIs (Active Pharmaceutical Ingredients) directly from originators.
This promotes the highest quality and traceability of our raw materials.

Our Facilities

Optimal Scripts operates multiple 503A and 503B facilities in the USA.
These facilities are equipped with state-of-the-art technology to produce high-quality pharmaceutical products.

Compliance

Optimal Scripts holds multiple FDA (Food and Drug Administration) and DEA (Drug Enforcement Administration) licenses.
These licenses demonstrate our commitment to compliance and safety.

Integrated Testing Labs

Optimal Scripts is committed to quality. Our facilities have integrated testing labs for quality assurance.
Our labs are CLIA (Clinical Laboratory Improvement Amendments)- and COLA (Commission on Office Laboratory Accreditation)-certified.
Our labs conduct rigorous testing for safety and efficacy of our products.

How We Developed Our Generic Drug

The process for a generic drug to enter the market in the United States involves several steps regulated by the U.S. FDA. Here's an overview of the process that approved Optimal Script’s generic semaglutide:

1. Submission of Abbreviated New Drug Application (ANDA)

The manufacturer of the generic drug submits an Abbreviated New Drug Application (ANDA) to the FDA. This application includes data demonstrating the drug's bioequivalence to the brand-name drug, as well as information on its safety, efficacy, manufacturing process, and labeling.

2. Review and Evaluation by the FDA

The FDA reviews the ANDA to ensure that the generic drug meets the same quality, safety, and efficacy standards as the brand-name drug. This involves assessing the bioequivalence of the generic drug to the brand-name drug, as well as evaluating its manufacturing process and labeling.

3. Approval of the ANDA

If the FDA determines that the generic drug is bioequivalent to the brand-name drug and meets all other regulatory requirements, it approves the ANDA. This allows the manufacturer to market and distribute the generic drug in the United States.

4. Patent Challenges

Before granting final approval, the FDA may need to address any patent challenges or exclusivity rights associated with the brand-name drug. This can involve litigation between the generic manufacturer and the brand-name manufacturer to resolve patent disputes.

5. Post-Market Monitoring

After the generic drug is approved and enters the market, the FDA continues to monitor its safety and efficacy through post-market surveillance programs. This helps ensure that any potential safety concerns are promptly identified and addressed. Overall, the process for a generic drug to enter the market in the U.S. involves rigorous evaluation by the FDA to ensure that it is safe, effective, and of high quality. This helps provide patients with access to affordable medications while maintaining stringent regulatory standards.

License & Certification

Optimal Scripts holds multiple FDA (Food and Drug Administration) and DEA (Drug Enforcement Administration) licenses. These licenses demonstrate our commitment to compliance and safety. Our facilities are fully automated, adhering to CGMP (Current Good Manufacturing Practices) standards. Our labs are CLIA (Clinical Laboratory Improvement Amendments) - and COLA (Commission on Office Laboratory Accreditation)-certified, assuring patients and healthcare providers of our legitimacy and ethical practices.

CGMP

FDA

CLIA

COLA

HIPAA

DEA

A Comparison of 503A & 503B Compounding Pharmacies

The Optimal Scripts brand is comprised of several 503A and 503B compounding pharmacies. Each plays a specific role in our manufacturing, logistical, and sales processes. Understanding the differences between the two will empower the sales force to explain why Optimal Scripts, made in America, is simply the best choice on the market.

Designations

503A: Compound Pharmacies

503B: Outsourcing Facilities

Regulatory Oversight

503A: Primarily regulated by state boards of pharmacy

503B: Regulated by the U.S. Food and Drug Administration (FDA)

Bulk Compounding

503A: Limited to small-scale compounding for individual patient prescriptions

503B: Permitted to produce large batches of compounded medications not for specific patient prescriptions

Quality Standards

503A: Subject to USP <795> and <797> standards for compounding practices

503B: Required to adhere to Current Good Manufacturing Practices (CGMP) standards

Drug Testing

503A: May perform in-house testing of compounded medications

503B: Required to conduct rigorous testing and quality assurance protocols

Labeling

503A: Must include patient-specific information and directions for use

503B: Labels must comply with FDA regulations for commercial drug products

Prescription Requirements

503A: Requires patient-specific prescriptions for each compounded medication

503B: Can compound medications without patient-specific prescriptions for office use