Resources · Your brand. Our science.
These are the questions buyers ask us most, answered in a few sentences each. They cover how white label and private label supply works, how to check a supplier and a certificate, what we need before a first order, and what we do not provide.
Made in USALast reviewed:
A white label peptide is a stock product that a manufacturer has already synthesized and tested, supplied under the buyer's brand. The specification is the manufacturer's. The buyer chooses from a catalog and supplies label artwork.
White label is a stock product carrying your label. Private label is made to order for one brand, to an agreed specification, as a dedicated lot. White label has lower minimums and shorter lead times. Private label gives you control of the specification and the pack.
An active pharmaceutical ingredient, also called a bulk drug substance, is the substance intended to become the active part of a finished drug. It is sold by weight to businesses that make finished products.
[Answer to be supplied after each named site is verified.] WhiteLabel Compounds products are made in USA. Many companies that sell peptides in the US fill, label or ship here without synthesizing here.
A 503A pharmacy compounds for an identified patient on a prescription, under a state pharmacy license. A 503B outsourcing facility registers with FDA, follows cGMP and can compound sterile drugs without patient-specific prescriptions. Each has its own rules on which bulk substances it may use.
No. "Compounds" in our name means chemical compounds. We are a manufacturer.
No. A US address can mean synthesis, filling, labeling, testing or only shipping. Ask which steps happen at which address, ask for the facility's registration number, and ask for a certificate that names the manufacturing site.
The product name, lot number and manufacture date. Each test with its method, the specification and the result, covering identity, purity and content. The laboratory's name and the signature of the person who released the lot. A certificate without a lot number or methods cannot be checked.
Match the lot number on the certificate to the lot number on the container. Confirm the laboratory exists and, if it claims accreditation, look it up with the accrediting body. Then ask the manufacturer to confirm the certificate directly.
It means a drug establishment has registered with FDA as the law requires. It does not mean FDA has approved the establishment or its products. FDA's own regulation says registration does not denote approval.
No. FDA does not approve manufacturing facilities. Our plant is registered with FDA as a drug establishment, FEI [FEI number]. Registration does not denote approval.
Current Good Manufacturing Practice is the set of quality requirements FDA enforces for drug manufacturing. For active pharmaceutical ingredients, FDA's guidance is ICH Q7. FDA assesses compliance by inspecting facilities.
Verified businesses. We confirm your business registration and license before a first order. See who we supply for the account types.
White label items start at [White label minimum units] per item. Private label starter runs start at [Starter run from]. API orders start at [API minimum grams].
We publish price bands for white label items on the white label page. Private label and API orders are quoted, because price depends on the specification and the lot size.
White label orders ship within [White label lead days] business days of label approval. Private label runs take [Private label lead weeks] from an approved specification. Every lot is released by our quality unit before it ships.
Three things under federal law. The supplier must be an FDA-registered establishment. Each lot must come with a valid certificate of analysis. The substance must have a USP or NF monograph, be a component of an FDA-approved drug, or be on FDA's 503A bulks list.
A peptide can be compounded if it has a USP or NF monograph, is a component of an FDA-approved drug, or is on FDA's 503A bulks list. [Dated status sentence to be supplied.] FDA's own list is the authority.
The manufacturer is always traceable. Every container carries the product identity, the lot number and the manufacturer.
Use the origin statement we give you for that product. Under the FTC's rule, an unqualified "Made in USA" claim needs all or virtually all ingredients and processing to be of US origin. Our statement names the steps performed in the USA.
What it is, who made it, how it was tested and where the certificate is. Your claims are your responsibility, and we do not supply claims about effects.
No. We supply storage and handling conditions on the specification sheet. We do not publish dosing, reconstitution or administration information, calculators or protocols.
Follow the storage conditions printed on the label and the specification sheet for that product. We ship in packaging matched to those conditions and record them on the shipping documents.