Which Drug Company Makes Metformin? | Brands And Generics

Here’s the quick orientation you came for. Metformin is an off-patent medicine with wide production. That means there isn’t one single maker. In the United States you’ll see dozens of FDA-approved manufacturers and labelers for metformin tablets and extended-release tablets, plus a few brand products such as Glucophage, Glumetza, and the oral solution Riomet. In Europe and many other regions, Glucophage is held by Merck Serono (Merck KGaA group). If you want the definitive source for who makes a specific product strength and dosage form sold in the U.S., the FDA’s Orange Book and the labeling pages on DailyMed list the current approvals and labelers.

Which Drug Company Makes Metformin? Quick Facts

Metformin is the international nonproprietary name (INN) for the same active ingredient used across many brands and generics. The molecule is identical across approved producers; what varies is the manufacturer, the dosage form (immediate-release tablets, extended-release tablets, or oral liquid), and the company that holds a particular brand name in a given country. In the U.S., the original branded metformin was Glucophage from Bristol-Myers Squibb; the current U.S. market is largely generic with multiple approved makers. In Europe, Glucophage and Glucophage SR are branded products from Merck Serono, the local affiliate of Merck KGaA.

Major Makers And Brands You’ll See

Below is a broad, in-depth table of well-known metformin makers and brand holders, with examples and authoritative label sources. This isn’t a complete list (the FDA maintains the official roster), but it covers the names you’ll most often encounter at the pharmacy counter.

Company	What They Make	Where / Notes
Bristol-Myers Squibb	Glucophage (original U.S. brand IR tablets)	See FDA label for Glucophage showing BMS as distributor/licensee (FDA label).
Merck Serono (Merck KGaA)	Glucophage / Glucophage SR (UK/EU)	UK SmPC lists Merck Serono as marketing authorisation holder (UK SmPC).
Bausch Health / Salix	Glumetza (metformin ER)	Current U.S. prescribing information lists Bausch Health (PI).
Sun Pharmaceutical	Riomet (metformin oral solution); Riomet ER	DailyMed and FDA labeling show Sun as distributor (Riomet label).
Andrx Labs (historical)	Fortamet (metformin ER) — brand now off the U.S. market	Original NDA holder was Andrx; brand discontinued in U.S. (NDA file).
Aurobindo Pharma	Metformin tablets (IR)	DailyMed package labels list Aurobindo (DailyMed).
Granules India / Granules Pharmaceuticals	Metformin tablets (IR), U.S. labeler Granules Pharmaceuticals	Label shows “Manufactured by: Granules India Limited” (DailyMed).
Lupin	Metformin (IR/ER in some markets)	Included among companies involved in 2020 ER recalls; current lots vary (FDA NDMA page).
Teva / Actavis	Metformin generics	Actavis lots were part of 2020 ER recall; IR remains widely available (FDA NDMA page).
Apotex	Metformin ER (select lots recalled in 2020)	See FDA notices for affected ER lots (FDA recall list).
Bausch Health (Canada)	Glumetza (ER) — Canada	Health Canada product listing shows Bausch Health Canada (Health Canada).
Merck Group	Glucophage family in many countries	Merck Group page for Glucophage (Merck HCP).

Who Manufactures Metformin Today: Brands, Labelers, And Generics

Pharmacies in the U.S. typically dispense metformin as a generic immediate-release tablet (500 mg, 850 mg, or 1000 mg) or as extended-release tablets (500 mg and 1000 mg). The bottle’s “labeler” name on the National Drug Code (NDC) tells you which company is responsible for the product on the U.S. market, and the DailyMed monograph often lists the manufacturing site as well. For instance, you’ll find Aurobindo-labeled immediate-release tablets, or Granules-manufactured tablets labeled by Granules Pharmaceuticals in Virginia via the DailyMed entry.

Branded ER tablets persist alongside generics. Glumetza remains a distinct extended-release formulation marketed by Bausch Health/Salix in the U.S., with a current U.S. prescribing information. Fortamet, a different ER brand originally approved under Andrx’s NDA in 2004, has been discontinued in the U.S. marketplace; pharmacies fill generic ER versions when available.

Why There Isn’t A Single Maker

Metformin’s patent protection ended long ago. Once exclusivity ended, many companies submitted abbreviated new drug applications (ANDAs) to the FDA, demonstrating equivalence to the brand. The FDA’s Orange Book lists the approved strengths and dosage forms along with therapeutic equivalence codes. This system encourages robust supply. If one manufacturer faces a shortage or a lot-specific recall, pharmacies can switch to another approved supplier.

Where Glucophage Fits In

Glucophage is the best-known original brand name for metformin. In the U.S., Bristol-Myers Squibb introduced it in the 1990s; the FDA label confirms the BMS connection for the brand’s U.S. history (FDA label). Outside the U.S. and Canada, Merck Serono (Merck KGaA) holds the Glucophage family in many markets, including SR (prolonged-release) tablets; the UK SmPC shows Merck Serono as the marketing authorisation holder (UK SmPC).

Which Drug Company Makes Metformin? Picking Out Your Exact Maker

Two product identifiers on your bottle can tell you who made your tablets: the NDC and the imprint code. The NDC’s first digits identify the labeler (the company responsible for the product). The imprint code on the tablet (letters/numbers pressed into the pill) maps to a specific manufacturer and strength. You can match either against the product’s page on DailyMed, which mirrors current FDA-filed labeling.

How To Identify Your Metformin Product

What You See	Where To Check	What You Learn
NDC on pharmacy label	Lookup on DailyMed	Labeler company, dosage form, strength, packaging
Tablet imprint (letters/numbers)	Compare against product photos on DailyMed	Manufacturer site or contracted producer
Brand name (Glucophage, Glumetza, Riomet)	Brand PI (FDA/Health Canada/UK SmPC)	Brand holder and formulation details

Safety Notes: The 2020 ER Recalls And What Changed

In 2020, the FDA announced recalls of certain extended-release (ER) metformin lots due to NDMA contamination. Multiple labelers were involved, including Apotex, Amneal, Teva (Actavis-labeled), Lupin, and Marksans/Time-Cap. The FDA maintains a running list and directs patients to check their specific lot numbers rather than stopping therapy abruptly. See the agency’s summary page and recall search tool for the official status: FDA NDMA updates and the recall search.

How Pharmacies Choose Which Metformin You Get

Most retail pharmacies contract with wholesalers and group purchasing organizations. Those contracts determine which approved manufacturer’s lots they stock for each strength. If your refill looks different, your pharmacist likely sourced the same strength from a different approved supplier. That’s common with generics. If you have concerns about an inactive ingredient or tablet size, ask your pharmacist to review the product’s label and, if needed, request an alternative manufacturer on your next fill.

Practical Steps To Confirm The Manufacturer

Scan The NDC

Check your prescription label for a 10- or 11-digit NDC. The first segment maps to the labeler. Enter that NDC into the search box on DailyMed to pull up the exact package insert and images. That page lists who makes the tablets and, often, the site where they’re manufactured (for example, “Manufactured by: Granules India Limited” on a U.S. label for Granules-branded tablets).

Match The Imprint

Compare the letters/numbers stamped on your tablet to the imprint listed on DailyMed for your NDC. The imprint is unique to a strength and manufacturer, so the match gives you confidence that your bottle and insert align.

Ask For A Specific Maker If You Need One

Patients who prefer a certain tablet size, coating, or dye profile can ask the pharmacy to note a preferred manufacturer for future fills. Availability varies, but pharmacies can often honor the request when stock and wholesaler contracts allow.

Brand-By-Brand Snapshot

Glucophage And Glucophage SR

In the U.S., Glucophage established metformin’s presence. The FDA label shows Bristol-Myers Squibb as distributor/licensee during the brand era. Outside the U.S. and Canada, Merck Serono holds the Glucophage family; the UK SmPC and Merck’s professional page confirm marketing rights and dose lineup (UK SmPC; Merck HCP).

Glumetza (Extended-Release)

Glumetza uses a different ER technology. It remains branded in the U.S. and Canada under the Bausch Health/Salix umbrella. See the current U.S. prescribing information and Health Canada’s listing for the product family (Drug & Health Products Portal).

Riomet And Riomet ER (Oral Liquid / For Suspension)

Some patients prefer liquid metformin. Riomet (oral solution) and Riomet ER (for suspension) are distributed in the U.S. by Sun Pharmaceutical; labeling and DailyMed entries show Sun as the trademark owner and distributor (DailyMed).

Fortamet (Extended-Release, Historical U.S. Brand)

Fortamet received FDA approval in 2004 under Andrx’s NDA; the brand is now discontinued in the U.S., with generics filling the space. The original NDA file remains accessible via the FDA’s archive (FDA NDA).

Does The Manufacturer Affect How Well It Works?

All FDA-approved generics must meet the same quality and bioequivalence standards as the reference listed drug. That said, excipients, tablet hardness, and coatings differ. Some patients notice a change in swallowing feel or timing of GI side effects when their pharmacy switches suppliers. If a particular version suits you better, ask the pharmacy to note your preference in your profile.

What About Outside The U.S.?

Every country has its own regulator and brand landscape. Across the EU, Glucophage and Glucophage SR appear alongside numerous national generics; the European Medicines Agency notes metformin’s long authorisation history dating back to the 1960s (EMA overview). In many markets, Merck Serono is the brand holder for Glucophage, while local firms produce approved generics.

Finding A Reliable List Of Makers

For the U.S., rely on two official sources. First, the FDA’s Orange Book for approved products, dosage forms, and therapeutic equivalence. Second, DailyMed for the current label, including the company that manufactures or distributes the finished product and, in many cases, the exact manufacturing site printed under “Manufactured by.”

Shopping Tips If You Care Which Company Makes Yours

Call Ahead

Ask the pharmacy which manufacturer’s NDC they have in stock for your strength. If they don’t have your preferred one, they can tell you what they do have and whether an order is possible.

Check Your Refill At Pickup

Before you leave, compare the imprint and NDC to what you had before. If it changed and you want the prior version, the pharmacy can advise on options.

Work With Your Prescriber

If you have a strong preference because of excipients or tablet size, your prescriber can write a note on the prescription requesting a specific generic manufacturer. Availability still depends on wholesaler contracts, but it can help.

Key Takeaways: Which Drug Company Makes Metformin?

➤ Metformin is generic with many approved makers.

➤ Glucophage began with BMS in the U.S.

➤ Merck Serono holds Glucophage in Europe.

➤ DailyMed and the Orange Book confirm makers.

➤ ER recalls targeted select lots, not all forms.

Frequently Asked Questions

Is Generic Metformin The Same As Glucophage?

Yes, the active ingredient is the same. FDA-approved generics must match the reference in strength, dosage form, and bioequivalence. Differences are in excipients, tablet size, or coating, which can change pill feel or timing of GI effects.

If a switch causes issues, ask your pharmacist about alternative manufacturers or consider an extended-release option if your clinician agrees.

Who Makes Metformin Oral Solution?

In the U.S., Riomet (metformin oral solution) and Riomet ER are distributed by Sun Pharmaceutical. The product labels on DailyMed list Sun and the manufacturing partner for each lot.

Ask your pharmacy which NDC they stock; liquid supply may be more limited than tablets.

How Can I Confirm The Manufacturer Of My Tablets?

Match the NDC on your bottle to the product page on DailyMed. The page lists the labeler and often the manufacturing site under “Manufactured by.” You can also match the tablet imprint to the images and descriptions on that page.

For a high-level view of all approved versions, search the FDA Orange Book by active ingredient.

What Happened With The 2020 NDMA Recalls?

Select extended-release lots from multiple labelers were recalled after testing found excess NDMA, a contaminant that can form during manufacturing. The FDA posted the affected companies and lot numbers and later cleared replacement supply.

Immediate-release tablets weren’t the focus of those early notices. Don’t stop therapy without a clinician’s advice; check the FDA recall pages instead.

Does The Country Of Manufacture Matter?

Quality standards are set by the regulator and enforced through inspections and lot testing, not by a country name alone. Many U.S.-approved generics are made at FDA-inspected sites worldwide, with the label showing site details.

If you have concerns about a specific site, ask your pharmacist to print the current product insert that lists the “Manufactured by” line.

Wrapping It Up – Which Drug Company Makes Metformin?

There isn’t a single answer because metformin is a mature, off-patent medicine produced by many FDA-approved firms in the U.S. and by numerous authorised manufacturers worldwide. If you want to identify the exact company behind your bottle, use the NDC and imprint to pull up the DailyMed label. For brand context, Glucophage established the name under Bristol-Myers Squibb in the U.S., while Merck Serono maintains the Glucophage family in Europe. Extended-release brands like Glumetza continue under Bausch Health, and liquid options like Riomet sit with Sun Pharmaceutical. With those references, you can always trace your exact product to a responsible manufacturer and choose a version that suits you.