Your Semaglutide Source
Affordable Weight Loss for Your Patient
Available for Office Use
Ready to Use Formula
Non Refrigerated Shipping
12 Month Shelf Life
Packs of 25
Semaglutide Base Form
Drug Master File API
FDA Licensed and 503B OF
Inquires
Are you a medical professional with a private practice? Are your patients in need of efficacious weight loss treatments?
Inquire how we can help become your provider today.
WHAT MAKES US DIFFERENT
We operate under a 503B license which holds us to a higher standard and we adhere to cGMP standards. Our semaglutide has a FDA’s National Drug Code Number, which makes it easier for prescribers to identify and track the medication, ensuring that patients receive the correct treatment.
Our product is pure semaglutide. We do not mix with untested ingredients like a peptide or B12 as there is no science related to the safety and efficacy of such mixtures.
Since you and or your patient do not have to reconstitute this will save time, energy, and help prevent mistakes. This also leaves less room for any mistakes in dosing.
Our manufacturer is a 503B facility and has the ability to produce large, consistent quantities providing major cost savings to healthcare partners and customer
Our product comes constituted and it is not lyophilized. Which means we do not freeze dry the product. We believe that this process could impact the quality and efficacy of semaglutide.
503B FACILITIES
What is a FDA 503B Outsourcing Facility?
It is a facility located at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B under the Drug Quality and Security Act (DQSA).
What are the Requirements for a 503B Outsourcing Facility?
503B outsourcers must comply with state and federal guidelines and meet strict Current Good Manufacturing Process (cGMP) standards. They must compound drugs under the direct supervision of a licensed pharmacist within the facility and have their compounded drugs and facility routinely inspected by the FDA.
What are the Benefits of a 503B Outsourcing Facility?
503B facilities are held to higher standards of safety and quality and must follow strict testing standards for sterility, potency, and endotoxins. Often through automation, 503B facilities also have the ability to produce higher volumes which provides major cost savings to 503B healthcare partners and customers.
FREQUENTLY ASKED QUESTIONS
No, the Semaglutide formulation is a ready to use product that does not have to be reconstituted.
Semaglutide vials are intended to be stored under refrigeration between 2°C to 8°C (36°F to 46°F) and protected from freezing and light.
In addition to the above storage conditions, the product can be kept from 8°C to 25°C (46°F — 77°F) up to 15 days and from 8°C to 35°C (46°F — 95°F) up to 4 days, according to specific temperature studies conducted.
The product has 8 months dating when refrigerated.
The Semaglutide API (Active Pharmaceutical Ingredients) only comes from FDA registered manufactures that have an active DMF (Drug master File) listed with the US FDA.
Our manufacturer only uses the base form of Semaglutide, similar to the FDA approved Semaglutide products.
No, the Semaglutide does not contain a sodium or acetate salt form. Products containing salt forms have not been shown to be safe and effective.
Our manufacturer only uses DMF active ingredients along with validated inactive ingredients to assure the purest materials are incorporated. All ingredients are tested inhouse, upon arrival and must meet our strict standards and methods that are developed with our manufacturer’s in-house QC chemistry lab and microbiology labs.
Dot RX is partnered with an FDA registered drug manufacturer who produces commercial sterile products utilized throughout hospitals nationwide. Our manufacturer is also a registered 503B Outsourcing Facility which executes with full CGMP operations with no difference from our commercial products.
No, our manufacturing facility only uses Semaglutide and no other added ingredients. Many compounding pharmacies add vitamins and additional medications. Our Semaglutide product does not contain any other ingredients as they are not proven to be safe or effective when combined with Semaglutide.
Disodium Phosphate Dihydrate, Sodium Chloride, Benzyl Alcohol and Water for Injection.
Our manufacturer is an FDA registered drug manufacturer along with a 503b outsourcing facility. Our partners are only one of a few companies in the country that have carry this dual licensure.
Our partner being a licensed drug manufacturer that produces commercially approved ANDA and NDA drugs, provides the confidence all 503b products are made under the same stringent standards. The manufacturing facility uses the same quality standards and same operating procedures to make all 503B products as it does FDA approved drugs.
Our manufacturer has been issued a NOC by the FDA because our manufacturer is a registered FDA drug manufacturer.
Because our partner carries dual licensure as a Drug Manufacturer and a 503b Outsourcing Facility they are able to support nationwide drug shortages, getting to consumers quicker, as long as that product is listed on the FDA drug shortage list.
The manufacturer has full chemistry and microbiology labs within their facility that allow them to meet more strict, self generated guidelines and parameters. This way, they provide full confidence in producing industry best results for the consumers.
Our drug manufacturing partner operates in ISO 5 clean environments, utilizing cutting-edge robotic filling technology to mix and fill our sterile products. This is unlike, most every other 503A or 503b, that uses technicians and laminar flow hoods during the compounding and filling processes.
