Regulated Medicine

GMP is a set of binding quality regulations that govern how medicines are produced, tested, and documented. It covers facility cleanliness, equipment calibration, staff training, raw material sourcing, batch record keeping, and in-process quality testing. A GMP-certified facility is inspected regularly by the issuing authority.

The key GMP standards applicable to our suppliers are:

• WHO-GMP — World Health Organization Good Manufacturing Practice
• EU-GMP — European Medicines Agency Good Manufacturing Practice
• USFDA cGMP — United States Food and Drug Administration current Good Manufacturing Practice
• PIC/S — Pharmaceutical Inspection Co-operation Scheme

India has more than 1,400 facilities certified to at least one of these standards — more than any other country outside the United States.

We source exclusively from Indian pharmaceutical manufacturers that meet at least one international GMP standard. We do not purchase from gray-market resellers, unverified wholesalers, or facilities without documented quality certifications.

Where a manufacturer is listed on one of our product pages, that name corresponds to the actual licensed producer of the product as supplied to us. Our manufacturer heritage data — founding year, headquarters location — is verifiable through public corporate records.

A generic medicine is considered bioequivalent to its brand-name counterpart when it contains the same active ingredient, in the same dosage and route of administration, and produces the same pharmacological effect in the body within a regulated tolerance range. Bioequivalence is established through clinical studies comparing blood concentration profiles (FDA bioequivalence guidance).

A generic tablet may have different inactive fillers, a different tablet color, or a different imprint — but the chemical action on the body is the same. This is why regulators worldwide accept bioequivalent generics as therapeutic substitutes for brand-name drugs.

We do not claim that our products are FDA-approved for sale in the United States. Most international generics are not registered with the USFDA for domestic distribution, even when they are produced in USFDA-inspected facilities. The distinction is important: USFDA inspection of a facility is separate from USFDA approval of a specific product marketed within the United States.

Customers are responsible for understanding the regulatory status of any medicine in their own country of residence. See our Disclaimer and the Personal Importation section of our Terms of Service for the legal framework that applies to personal-use importation of medicines.