FDA Drug Establishment Registration

Under 21 CFR 207.77, registration "does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed."

What registration tells FDA, and what it does not

The same rule says a representation that registration signals approval is misbranding, a violation of the Federal Food, Drug, and Cosmetic Act. FDA's electronic registration and listing page adds that registering "does not indicate the products are approved or that FDA has verified the information provided."

Foreign makers are covered. 21 CFR 207.17 requires registration of any foreign establishment that makes a drug imported or offered for import into the US. FDA's API import page (current as of 15 June 2026) applies this to active pharmaceutical ingredients (APIs, the substances that make a medicine work) and requires foreign makers to list each importer they know of. To tell the substance from the finished medicine, see drug substance vs drug product.

Listing is a separate filing that names each product. Private label distributors that do not manufacture, repack, relabel or salvage are not required to register.

"FDA registered" is read as "FDA checked" when it means only "FDA was told." The label measures the supplier's paperwork, not its quality system, and the consequences land on the importer. FDA's shipment admissibility page (current as of 15 June 2026) says a drug may be misbranded if its manufacturer has not registered and listed.

The worked example is the 2017 Sal Pharma letter above. Two of the company's suppliers were not registered as drug manufacturers, and the company left the original manufacturers' names and addresses off the COAs it sent customers. FDA wrote that "customers and regulators rely on COA for information about the quality and source of drugs."

Three confusions follow from that case. Registration is not approval. A National Drug Code (NDC, a product identifier) or a DMF is not approval either. And a seller's registration says nothing about the plant that actually made your batch.

FDA's Drug Establishments Current Registration Site (DECRS) confirms that a named site is currently registered. It does not confirm quality. FDA's DECRS page (current as of 5 February 2026) says the file is updated each business day. It also says sites whose registration expires or is inactivated drop off the list.

Registration must be renewed between October 1 and December 31 each year. DECRS does not include wholesale distributors or third-party logistics providers, so a trader can be legitimate and still not appear. The useful lookup is the manufacturing site, not the seller. For the wider qualification map, see API suppliers for US importers.

Inspection history is held elsewhere. The FDA Data Dashboard shows final classifications, updated weekly:

• NAI: No Action Indicated.
• VAI: Voluntary Action Indicated.
• OAI: Official Action Indicated.

Its notes say it excludes pre-approval inspections, and some records may be withheld until compliance actions finish. FDA's inspections page says it aims to classify an inspection within 90 days of its end and generally posts the classification to the Data Dashboard. A clean dashboard entry is therefore not proof of a clean site today.

Ask for six items and test each one, because registration alone proves none of the quality points. The pass and fail columns are a recommended reading, not an FDA rule.

A DMF is reviewed only when an applicant references it. FDA's DMF guideline states that "a DMF is never approved or disapproved."

GMP evidence needs its own reading; what a WHO-GMP certificate proves covers it. An ICH Q7 audit report is the international GMP guideline for APIs. A Letter of Authorization is the DMF holder's permission for FDA to review the file for your company; compare batch documents with your quality agreement.

FDA's proposed rule on distributed manufacturing and certain foreign establishments (91 FR 42888, published in the Federal Register on 13 July 2026) would clarify that registration and listing apply to foreign establishments whose drug is further processed at another foreign establishment before import. It is a proposal and does not change current obligations. Asking for every site in the chain is already sound practice.

Aarise Pharmaceuticals operates as an API supplier, sourcing partner and exporter, not as the plant that makes every batch. It supplies bulk pharmaceutical, steroid, hormone and peptide APIs to business buyers and supports documentation and supply for US importers. It does not offer DMF, Certificate of Pharmaceutical Product (CPP) or Certificate of Suitability (CEP) support for steroid APIs, and it does not publish a US FDA establishment registration for itself.

Buyers should check the manufacturer's registration in DECRS themselves and remain responsible for confirming local registration, import authorization and permitted end use.

Buyers can send the document table through the contact page, and Aarise Pharmaceuticals will say per product which items it can supply and which it cannot.