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.