Hauppauge, New York · Extracting botanicals since 1972
Nutraceutical Contract Manufacturer in New York
BioB Manufacturing makes finished nutraceutical products on Long Island — and makes the botanical extracts that go into them. One 160,000 sq ft FDA-registered facility in Hauppauge, New York holds both the active and the finished bottle.
- Published minimums. Liquids from 2,500 units. Capsules and tablets from 300,000 units total. No “available on request”.
- We make the actives. Bio-Botanica has extracted botanicals since 1972. Our finished-goods arm runs on our own extract library.
- NSF GMP, USDA Organic, Kosher and Halal in an FDA-registered facility, manufacturing under 21 CFR Part 111.
Talk to a manufacturing engineer: (631) 231-5522
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NSF GMP
FDA-registered facility
USDA Organic
Kosher
Halal
Made in Hauppauge, NY
Extracting botanicals since 1972
1972
Extracting botanicals in New York since
160,000
Sq ft FDA-registered facility, Hauppauge NY
2,500
Unit minimum on liquids 8 oz and larger
300+
Ready private label formulations in catalog
What is a nutraceutical contract manufacturer?
A nutraceutical contract manufacturer produces finished nutraceutical products — supplements, functional liquids, capsules, tablets and powders — under another company’s brand name. It handles formulation, sourcing, blending, filling, packaging and batch documentation in a facility operating under 21 CFR Part 111, while the brand owns the label, the marketing and the regulatory filings.
In practice the word covers two very different kinds of company. One is a filler: it buys finished actives on the open market, blends them to your spec, runs them into a bottle and hands you a Certificate of Analysis from someone else’s lab. The other controls the input as well as the output. BioB Manufacturing is the second kind. We are the finished-goods arm of Bio-Botanica, Inc., which has been extracting botanicals at the same Hauppauge, New York address since 1972.
That distinction shows up in the parts of a project buyers usually discover too late: whether the extract behind your hero ingredient can be reformulated when a supplier changes, whether the identity documentation on that active came from the people who made it, and whether a reorder is exposed to an importer’s lead time. Contract manufacturing is a supply chain decision as much as a production decision.
What is the difference between a nutraceutical and a dietary supplement?
“Dietary supplement” is a legal category defined by DSHEA: a product taken by mouth, labeled as a dietary supplement, containing a dietary ingredient. “Nutraceutical” is a marketing and industry term with no FDA definition. It covers dietary supplements plus functional foods and beverages. Every dietary supplement can be called a nutraceutical; not every nutraceutical is a dietary supplement.
The practical consequence is regulatory. If the product is a dietary supplement, it is manufactured under 21 CFR Part 111 and labeled with a Supplement Facts panel. If it is a conventional food or beverage carrying a functional ingredient, a different set of rules applies to the facility and the panel. Deciding which one you are making is the first conversation, not a detail to settle after the formula is locked. BioB manufactures dietary supplements under Part 111.
How big is the nutraceutical contract manufacturing market?
Precedence Research values the global nutraceutical contract manufacturing services market at USD 187.92 billion in 2025, projecting USD 577.95 billion by 2035 at an 11.89% CAGR. Source: Precedence Research, Nutraceutical Contract Manufacturing Services Market. Useful context for a board deck; it will not tell you what your run costs. The rest of this page is the part that will.
What we manufacture
Liquids are the specialty. Most contract manufacturers treat liquid as the difficult format and steer you toward a capsule; we built the company on extraction, so liquid is the native case. Alcohol-free formats matter here: our alcohol-free extracts are made for ingestible products, which opens up the families that a traditional tincture base closes off.
Liquid supplements, including alcohol-free
Tinctures, concentrates, drops, syrups and liquid blends. Alcohol-free extract bases for ingestible products. Minimums are published below and are lower for 8 oz and larger.
Capsules
Powder-filled two-piece capsules from botanical extracts, vitamins, minerals and blends. Encapsulation runs carry a 300,000-unit total minimum.
Tablets
Compressed tablets, including coated finishes. Same 300,000-unit total minimum as capsules, for the same reason: tooling and press setup.
Powders
Blended powders for bulk canisters, sticks and scoops. Flavor and solubility work is done in house. Minimum confirmed at quote.
Oral care
Rinses and oral liquids built on the same botanical inputs. Format and pack size drive the run; minimum confirmed at quote.
Pet wellness
Liquids and powders for companion animal brands, using the same extract library and the same batch documentation. Minimum confirmed at quote.
The input behind all of it is the extract library. Bio-Botanica maintains a large working range of botanical extracts produced in house, and BioB formulates from it. That is the difference between a manufacturer and a filler: when a formula needs a different ratio, a different solvent base or an alcohol-free version of an active, that is a production conversation down the hall rather than a purchase order to a broker. Browse the finished formats on our full product range, or read the capability detail on our dietary supplement manufacturing page.
Minimum order quantities by format
Liquids under 8 oz start at 5,000 units. Liquids 8 oz and larger start at 2,500 units. Capsules and tablets each start at 300,000 units total per order. Every other format is confirmed at quote. We publish these because the rest of the category hides them behind a contact form.
| Format | Minimum order | What sets it |
|---|---|---|
| Liquids under 8 oz | 5,000 units | Filling line changeover and cleaning on small-fill bottles |
| Liquids 8 oz and larger | 2,500 units | Fewer units for the same batch volume, so the floor drops |
| Capsules | 300,000 units total | Encapsulation setup; counted across the whole order, not per SKU |
| Tablets | 300,000 units total | Tooling and press setup; counted across the whole order |
| Powders | Confirmed at quote | Blend size, pack format and fill weight |
| Oral care | Confirmed at quote | Format and container |
| Pet wellness | Confirmed at quote | Format and container |
| Lozenges | Confirmed at quote | No published minimum for this format |
| Topicals (creams, serums, lotions, sprays, oils) | 5,000 units | Separate line; same facility and same quality system |
On lead time: we do not publish a fixed schedule, because on nearly every project the timing is set by packaging, not by us. Bottles, closures, droppers, cartons and printed labels arrive on their own clocks, and a decorated component can outrun the bulk by a wide margin. We confirm a schedule at quote once the components are specified, and we tell you which item on the bill of materials is the one holding the date.
Minimums are per order rather than per SKU on capsules and tablets, which is how a brand launching three strengths reaches the floor without warehousing a year of one of them. If your volume is below a published figure, say so in the form — sometimes the answer is a different pack size, and sometimes it is honestly that we are not the right fit yet.
Three ways to work with us
1. Private label
Take one of 300+ existing formulations, put your label on it and go. Fastest route to a shelf-ready product and the least development risk. Detail on our private label supplement manufacturing page.
2. Semi-custom
Start from a proven base and change what matters: swap or add an active, adjust strength, change the flavor, move to an alcohol-free base, or re-spec the pack. Most of the development work is already done and paid for.
3. Full custom
Ground-up development from a target profile, a claim direction and a landed cost. Bench work, pilot batches, specification setting and scale-up. See contract manufacturing made to your specification.
We make the actives, not just the bottle
This is the part of the page that no page-one competitor on this term can copy. Bio-Botanica, Inc. has manufactured botanical extracts since 1972. BioB Manufacturing is its finished-goods arm. The extraction and the finished product happen at one address in Hauppauge, New York — the active is made in the same 160,000 sq ft FDA-registered facility that fills your bottle.
Every other nutraceutical contract manufacturer ranking for this term buys its botanical actives from someone else. That is not a criticism of them; it is a structural fact about where the risk sits. When the active is purchased, four things are outside the manufacturer’s control:
- Identity and documentation. The paperwork on the active originates with a third party. Qualifying that supplier becomes work you and your manufacturer both repeat.
- Reformulation speed. A ratio change, a different extract base or an alcohol-free version means a new purchase order and a new qualification cycle rather than a production run.
- Continuity of supply. A broker’s crop year, allocation or discontinuation lands on your reorder date, and you find out when the reorder is already late.
- Landed cost. An imported active carries freight, duty and currency exposure that gets rebuilt into your unit cost every time the market moves.
Controlling the extract does not make us cheaper on a commodity blend, and we will say so. Where it changes the outcome is any product whose story is the botanical: a standardized extract, an unusual plant part, an alcohol-free base, or a formula you expect to iterate on over several years. More on the company at about BioB Manufacturing and the people running it on our team page.
How a nutraceutical project runs
1
Scoping call
Format, target market, volume, pack and budget. We tell you on this call whether your volume clears the minimum for the format you want, and if it does not, what would.
2
Formulation
Pick a stock formulation, modify a base, or develop from scratch. Actives are drawn from our own extract library wherever the formula allows it.
3
Samples and specification
Bench samples, then the written specification: actives, excipients, panel, appearance, container and closure. Nothing scales until the spec is signed.
4
Components and artwork
Bottles, closures, cartons and printed labels are specified and ordered. This is normally the longest item on the schedule, so it starts early.
5
Production and testing
Batch manufactured under 21 CFR Part 111 with in-process controls, identity verification on dietary ingredients, and finished-product testing against the spec.
6
Release and documentation
Batch record reconciled, Certificate of Analysis issued for the lot, retention samples held, and the documentation package handed over with the shipment.
Quality, testing and the documents you actually receive
A quality system you cannot see is a quality system you cannot use in an audit. Here is what physically arrives with a BioB lot, and why each piece exists.
| Document or control | What it is | Why it matters to you |
|---|---|---|
| Certificate of Analysis | Per lot, listing the specifications tested and the results obtained | Your primary evidence of conformance, and the document a retailer or distributor asks for first |
| Identity verification of dietary ingredients | At least one appropriate test or examination on each dietary ingredient before use | A specific Part 111 requirement and a routine focus of FDA inspection |
| Written specifications | Component, in-process, finished-product and packaging specs agreed before production | Defines what “correct” means, so a rejected lot is a fact rather than an argument |
| Batch production record | The executed record of what was made, from what, by whom and in what sequence | Traceability from finished bottle back to incoming raw material |
| Retention samples | Reserve samples of the lot held after shipment | Lets a later question about a specific lot be answered with the material itself |
| Stability data | Scoped per project and per package where a shelf life is required | Supports the expiration or best-by date you print on the label |
| Certification coverage | NSF GMP, USDA Organic, Kosher and Halal in an FDA-registered facility | Sell into channels and markets that require them without a second vendor |
We do not claim certifications we do not hold, and we will tell you plainly when a market you are targeting needs one that is outside our current scope. The full list is on our standards and certifications page.
21 CFR Part 111: who is responsible for what
Both of us are manufacturers in the eyes of the regulation. BioB is responsible for manufacturing, packaging, labeling and holding operations in our facility. A brand owner whose name is on the label is also a manufacturer under 21 CFR Part 111 and carries its own independent obligations, whether or not it ever touches the product.
| Responsibility | BioB Manufacturing | You, the brand owner |
|---|---|---|
| Manufacturing under Part 111 in the facility | Ours | Verify through qualification and audit |
| Written specifications and testing to them | We test and document | Approve the specifications |
| Certificate of Analysis per lot | We issue it | Qualify the supplier before relying on it |
| Supplier qualification under §111.75 | We supply the evidence | Yours to perform, document and reconfirm |
| Label content and Supplement Facts panel | We print what you approve | Yours — content, claims and accuracy |
| Structure/function claim substantiation and the FDA notification | Not ours | Yours |
| New Dietary Ingredient notification, where required | Not ours to file | Yours — at least 75 days premarket |
| Serious adverse event reporting | Not ours | Yours, as the firm named on the label |
| Product complaints and recall decisions | We support with records | Yours to decide and execute |
Why a Certificate of Analysis is not enough on its own
This is the part most brands learn during an inspection. Under §111.75 you may rely on a supplier’s Certificate of Analysis only after you have qualified that supplier: confirm the COA with your own testing, document why the supplier is qualified to produce that result reliably, and periodically reconfirm it. Holding a stack of COAs in a folder is not a qualification program, and a regulator will read it as exactly what it is.
What we do about it is unglamorous and specific. We give you the written specifications, the identity verification evidence, the batch documentation and access to the facility, so the qualification work in front of you is verification rather than archaeology. Read the regulation yourself: 21 CFR Part 111 on eCFR. Most manufacturers would rather you did not.
Why brands choose BioB Manufacturing
Made in New York, start to finish
One 160,000 sq ft FDA-registered facility in Hauppauge, on Long Island. The extract and the finished bottle come from the same site, so there is no ocean freight in the middle of your supply chain and no tariff surprise arriving inside your landed cost.
The actives are ours
Bio-Botanica has extracted botanicals since 1972. When a formula needs a different extract ratio or an alcohol-free base, that is a production decision here rather than a purchase order to a broker with its own lead time.
Ingestible and topical, one vendor
Liquids, capsules, tablets, powders, oral care and pet wellness alongside creams, serums, lotions and sprays. A brand launching a supplement and a companion topical gets one quality system and one documentation package instead of two.
Numbers you can plan against
Published minimums by format, an honest answer on scheduling rather than a made-up one, and a clear account of which regulatory obligations are ours and which are yours. That is the whole pitch.
Nutraceutical contract manufacturing FAQs
What is a nutraceutical contract manufacturer?
A nutraceutical contract manufacturer produces finished nutraceutical products under another company’s brand. BioB Manufacturing formulates, blends, fills, packages and documents liquids, capsules, tablets and powders at a 160,000 sq ft FDA-registered facility in Hauppauge, New York. The brand owns the label, the claims and the FDA filings; we own the manufacture and the batch record.
What is the difference between a nutraceutical and a dietary supplement?
Dietary supplement is a legal category under DSHEA: taken by mouth, labeled as a dietary supplement, containing a dietary ingredient. Nutraceutical is an industry term with no FDA definition that also reaches functional foods and beverages. Every dietary supplement can be called a nutraceutical; not every nutraceutical meets the legal definition of a dietary supplement.
What are your minimum order quantities?
Liquids under 8 oz start at 5,000 units. Liquids 8 oz and larger start at 2,500 units. Capsules and tablets each start at 300,000 units total per order rather than per SKU. Powders, oral care, pet wellness and lozenges are confirmed at quote. Topicals start at 5,000 units.
What drives the cost per unit?
Four things: the formula, the packaging, the run size and the testing. Botanical actives and standardized extracts cost more than commodity blends. Packaging is frequently the largest single line and the longest lead item. Larger runs spread setup and cleaning across more units. We quote the four separately so the trade-offs are visible.
Do I need a finished formula before contacting you?
No. There are three routes. Choose from 300+ existing private label formulations and change only the label. Take one as a base and modify the actives, the strength, the flavor or the pack. Or start from a target profile and a price point and we develop the formula from the ground up.
Do you provide a Certificate of Analysis for every lot?
Yes. Every lot ships with a Certificate of Analysis tied to the batch record for that lot, reporting the specifications the batch was tested against and the results obtained. Under 21 CFR Part 111 you should not rely on a supplier COA alone, so we also supply the specifications and batch documentation behind it.
Who is responsible for compliance under 21 CFR Part 111?
Both of us. We are responsible for manufacturing under Part 111 in our facility. A brand owner that holds the label is itself a manufacturer under Part 111. Under §111.75 you must qualify your supplier rather than accept a Certificate of Analysis on trust: confirm it with your own testing, document the qualification, and periodically reconfirm it.
Do you verify the identity of dietary ingredients?
Yes. 21 CFR Part 111 requires at least one appropriate test or examination to verify the identity of every dietary ingredient before it is used, plus confirmation that other components meet their specifications. Bio-Botanica has identified and tested incoming botanical raw material since 1972, and the same discipline applies to the actives we make in house.
What is an NDI notification and who files it?
A New Dietary Ingredient notification is a premarket submission to FDA, made at least 75 days before a supplement containing an NDI is introduced into interstate commerce, unless the ingredient was marketed in the United States before 15 October 1994 or is otherwise exempt. The obligation sits with the manufacturer or distributor of the finished supplement, normally the brand. BioB does not file NDI notifications for customers.
Can we audit the facility or visit before committing?
Yes. We host qualification audits and customer visits in Hauppauge by appointment, and we complete supplier qualification questionnaires. Bringing your quality lead to the plant is the fastest way to close out the supplier qualification work Part 111 puts on you. Call (631) 231-5522 or book a call to arrange it.
Do you run stability testing and set the shelf life?
Stability is scoped per project and per package, because shelf life is a property of a formula in a specific container and closure rather than of the formula alone. We agree the protocol, the storage conditions and the pull points in writing before the first production batch, and the resulting data supports the date you print.
Do you also manufacture topicals?
Yes. BioB manufactures creams, serums, lotions, sprays and oils alongside ingestibles, at a 5,000-unit minimum for topicals. A brand launching a supplement and a companion topical gets one vendor, one quality system and one documentation package. Formats and minimums are on our private label skin care manufacturing page.
Get a nutraceutical manufacturing quote
Tell us the format, the volume and the target market. You get published minimums, an honest read on what will set your schedule, and a clear split of who is liable for what — before you commit to anything.
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