Dietary supplement contract manufacturing · Hauppauge, New York
Dietary Supplement Manufacturer
A US dietary supplement manufacturer with published minimums, a 160,000 sq ft FDA-registered facility in New York, and its own botanical extraction operation running since 1972. Liquids are our specialty, including alcohol-free. We also run capsules, tablets and powders.
- Published minimums, not “available on request”. Liquids start at 2,500 units.
- We make the actives — botanical extracts produced in the same building as your finished goods.
- One FDA-registered US site. No import exposure, no offshore quality gap.
Talk to a formulator: (631) 231-5522
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NSF GMP certified
FDA-registered facility
USDA Organic
Kosher
Halal
Made in Hauppauge, NY
Extracting botanicals since 1972
1972
Extracting botanicals since
160,000
Sq ft FDA-registered facility
5,000
Unit minimum, liquids under 8 oz
300+
Ready private label formulas
What dietary supplement formats does BioB manufacture?
BioB manufactures liquid dietary supplements, including alcohol-free liquids, plus capsules, tablets and powders. We also produce oral care and pet wellness supplements. Liquids are the specialty: Bio-Botanica has extracted and formulated botanicals in liquid form since 1972, in the facility that fills your goods.
Most of this market treats liquids as a footnote behind capsules and gummies. We built the company on them. A liquid raises questions a powder line never answers: whether a botanical extract stays in solution at your dose, how it tastes unmasked, whether it holds up in the bottle, and whether it can be made without ethanol at all. Those are extraction problems before they are filling problems.
Liquid supplements
Our lead capability, built on botanical extracts we produce ourselves. Fills under 8 oz and 8 oz and larger, blended, filled and finished on one site.
Alcohol-free liquids
Alcohol-free extracts and finished alcohol-free liquids, for brands whose channel or certification path rules out an ethanol carrier. Ingestible only.
Capsules
Capsule supplements at production scale, including formulas using our own botanical extracts. Minimum 300,000 units total across the order.
Tablets
Tablet supplements at production scale, minimum 300,000 units total. Suited to an established SKU with a repeat forecast, not a first market test.
Powders
Powder blends and single-ingredient powders. Minimums confirmed at quote, because they move with the blend, the bulk density and the container.
Oral care and pet wellness
Oral care and pet wellness products, drawing on the same extract library and quality system as the human ingestible lines.
What is the minimum order quantity for dietary supplement manufacturing?
Liquid supplements start at 5,000 units under 8 oz and 2,500 units at 8 oz and larger. Capsules and tablets require 300,000 units total, counted across the order. Powders and other formats are confirmed at quote. Published numbers, not a figure released after a discovery call.
| Dosage form | Published minimum | What moves it |
|---|---|---|
| Liquid supplements, under 8 oz | 5,000 units | Small fills burn more components and more line time per batch. |
| Liquid supplements, 8 oz and larger | 2,500 units | Our lowest published minimum, and the most accessible first run with us. |
| Capsules | 300,000 units total | Counted across the order, not per SKU, so a multi-SKU program can reach it together. |
| Tablets | 300,000 units total | Counted across the order. Tooling and compression setup set the floor. |
| Powders | Confirmed at quote | Blend complexity, bulk density and container format decide the practical batch. |
| Oral care, pet wellness, other formats | Confirmed at quote | We will not publish a number we cannot hold. Ask, and you get a real one in writing. |
How long does dietary supplement manufacturing take?
We do not publish a lead time, because any number quoted before we have seen your project is padded or quietly excludes what eats the calendar. Five things drive yours. Packaging is almost always the long pole: bottles, closures, droppers and labels must land before filling starts. Raw material sourcing is agricultural — an extract we already run is fast, a new botanical is not. Formula status: catalog moves now, a modified base needs a bench trial, full custom needs R&D rounds you sign off. Testing and release scoped into your specification must finish first. Artwork approval gates the run more often than the line does. Repeat runs of a qualified formula are materially faster. Tell us your on-shelf date and we will say honestly whether it is reachable.
Which manufacturing pathway fits your brand?
Three routes. Private label puts your brand on a proven formula from a catalog of more than 300. Semi-custom modifies one of those bases. Full custom develops a formula from the ground up. Speed, cost and differentiation move in opposite directions across the three.
Private label
Pick from 300+ existing formulations, apply your brand, run it. Already formulated, specified and documented, so it is the fastest, lowest-risk route to market. Best when proving demand matters more than owning a unique formula.
Semi-custom
Start from a catalog base and change what matters: swap or add a botanical extract, adjust an active level, move from ethanol to alcohol-free, redirect the flavor. Genuinely yours, without full development time.
Full custom
Ground-up development with our formulators and extraction chemists. You bring the concept and target actives; we build the formula, the specification and the manufacturing record.
Why does it matter that we make our own botanical extracts?
Because the active is the part of a botanical supplement most likely to go wrong, and most contract manufacturers buy theirs from a broker. Bio-Botanica has extracted botanicals since 1972. When BioB makes your product, the extract inside it usually came from the same building.
Three practical consequences. Provenance: we can tell you what the raw botanical was and what was done to it, because we did it, rather than forwarding a supplier document we ourselves have to qualify. Control: if a batch of extract misses specification we know before it reaches your fill, and we change the extraction instead of renegotiating with a vendor. Formulation freedom: an extract house can move the carrier, the ratio or the concentration to make a formula work; a filler buying finished actives can only change how much it adds. It is also why alcohol-free is real here: that is an extraction decision, not a blending one.
How does supplement manufacturing work, step by step?
Six steps from first call to delivered goods: scoping, formulation, quote and specification sign-off, component and raw material qualification, production under batch record, then release with documentation. You approve at each gate, and nothing advances without your sign-off.
1
Scope the project
You give us the dosage form, the actives, the volume and the channel. We say immediately whether it is catalog, a modification or development work, and whether your volume clears the minimum.
2
Formulate or select
We point you at an existing formulation, or our formulators and extraction chemists build one. Samples let you assess taste, appearance and dose. Iterations happen here, before anything reaches a production record.
3
Quote and sign off the specification
You get pricing, the confirmed minimum for your format, and a written finished-product specification. That specification is the contract for what gets made and what gets tested.
4
Qualify components and materials
Packaging is sourced and approved, artwork is checked against the specification, and incoming raw materials are held under quarantine, released to production only once identity is confirmed.
5
Manufacture under batch record
The batch runs against a master manufacturing record, with in-process checks recorded as work proceeds and a unique lot number assigned to your goods.
6
Release, document and ship
Quality reviews the completed batch record against the specification and releases the lot. You receive the goods and the documentation package. Reorders skip most of steps two through four.
What quality testing and documentation do you receive?
Every lot ships with a Certificate of Analysis issued against your agreed finished-product specification, and stays traceable through a batch production record retained here. What gets tested is decided in your specification at quote stage, not assumed. We would rather name what is scoped than imply a panel you are not buying.
What you actually receive
- Certificate of Analysis, every lot — issued against your specification and tied to the lot number on the goods, not a one-time document reused across a year of production.
- The finished-product specification — agreed in writing before production. It defines the identity, physical attributes and test parameters your product is judged against, and your own quality file should be built on it.
- Lot traceability — a unique lot number tying finished goods back through the batch record to the raw material and component lots inside them. If you ever have to answer a question about one bottle, the chain exists.
- Certification status documentation — support for USDA Organic, Kosher and Halal where your formula and its inputs qualify. We confirm at quote which yours can carry, since it depends on every input, not our facility alone.
- Master and batch production records — retained here and open for review during a customer audit, alongside reserve samples held per lot.
- Incoming material identity records — because we extract our own botanicals, that chain often starts at the plant material rather than a broker’s paperwork.
- NSF GMP certification and FDA facility registration — in a form you can file directly in your supplier qualification record.
Scoped per project, not promised by default
Stability studies and shelf-life dating are a scoped work package: protocol, timepoints and storage conditions all cost time and money, so they are agreed at quote, and we will not assign a date we have not supported. Testing beyond your specification — whatever a particular retailer, marketplace or export market demands — is added to the specification and priced when you tell us about it. Third-party laboratory work to a named external standard is arranged on request. And label review is support, not a legal opinion: we check artwork against the specification and flag what looks wrong, but your regulatory counsel signs it off.
Name your retailer, marketplace or export market at quote stage. Building those requirements into the specification costs far less than retrofitting them onto a finished lot.
Who is responsible for 21 CFR Part 111 compliance — you or your manufacturer?
Both of you, separately. Under 21 CFR Part 111, a brand owner that holds the label is itself a manufacturer, even though it never touches the product. Your contract manufacturer’s compliance does not transfer to you, and brand owners who assumed otherwise have found that out the hard way.
Part 111 is the current Good Manufacturing Practice regulation for dietary supplements, covering personnel, plant, equipment, production and process control, holding and distribution, returns, complaints and records. The full text is public: 21 CFR Part 111 on eCFR. Almost no manufacturer explains what it puts on the brand owner. Here is the honest split.
| Obligation | BioB, as your manufacturer | You, as the brand owner on the label |
|---|---|---|
| Written procedures and a quality unit | We hold the quality system, the SOPs and the unit that releases every batch. | You need written procedures for what you control, including how you qualify us. |
| Identity of incoming ingredients | Confirmed before release to production; for our own extracts the chain starts at the plant material. | You must show you verified this happens, not merely that you were told it does. |
| Master and batch production records | Written, executed and retained by us for every lot of your product. | Hold the specification and the per-lot COA in your own file at minimum. |
| Finished product specification | Drafted with you and tested against. We will not manufacture to an undefined specification. | You approve it. A missing parameter that matters to your claim is your gap to close. |
| Supplier qualification, §111.75 | We supply the documentation that shortens the work, listed below. | Yours. You must qualify us independently. A COA alone is not sufficient. |
| Complaints and adverse event reports | We investigate manufacturing-related complaints you route to us and document the outcome. | You receive them, keep the file, and carry the reporting duty as the labeler. |
| Labeling and claims | We review artwork against the specification and flag conflicts we can see. | The claims are yours, as is structure and function claim substantiation and notification. |
The §111.75 trap: a COA is not enough on its own
This is the most misunderstood obligation in the industry. Under §111.75, a brand owner holding the label is itself a manufacturer under Part 111 and must independently qualify its supplier before relying on a Certificate of Analysis. That means three things in practice: confirm the COA with your own testing rather than taking it at face value, document the qualification you performed, and periodically reconfirm it rather than qualifying us once and filing it away. Buying from a certified facility is a good idea. It is not the same as having done your own work — and most brand owners learn that during a retailer audit or an FDA inspection.
What BioB supplies to shorten that work
- NSF GMP certification and FDA facility registration, in a form that drops straight into your supplier qualification file.
- The finished-product specification we manufacture and test against, so your confirmatory testing has a defined target rather than a guess.
- A Certificate of Analysis per lot, tied to the lot number, so confirmatory testing can be sampled against a specific batch.
- Batch documentation open for review during a customer audit, a facility you are welcome to walk, and a named quality contact who answers a written questionnaire rather than routing it to a sales inbox.
None of this discharges your obligation. It turns it into a manageable amount of work instead of an open-ended one.
Why brands choose BioB Manufacturing
We manufacture in the United States, we make the actives, and we put our minimums and our obligations in writing before you speak to a salesperson. The US dietary supplement contract manufacturing market was valued at USD 6,649.3 million in 2025 and is projected to reach USD 16,644.3 million by 2033, a 12.2% CAGR, per Grand View Research. No shortage of manufacturers; a shortage of straight answers.
One US site, no import exposure
One 160,000 sq ft FDA-registered facility in Hauppauge, New York. No tariff surprise buried in your landed cost, no ocean freight in your lead time, and when something needs looking at, someone walks down the hall.
We control the actives
Bio-Botanica has extracted botanicals since 1972; BioB is its finished-goods arm. That is the difference between telling you where your active came from and forwarding a document from someone who told you.
Ingestible and topical, one roof
Launching a supplement and a companion topical? Run both here: one vendor, one quality system, one documentation package. Brands learn the cost of splitting that only after doing it.
Published minimums, honest timelines
Our minimums are on this page. We will not publish a lead time we cannot honor, but we will tell you what drives yours and give you a real date in the quote.
Explore more of BioB Manufacturing
Dietary supplement manufacturing FAQ
What is the minimum order quantity for dietary supplement manufacturing?
Liquid supplements start at 5,000 units for fills under 8 oz and 2,500 units at 8 oz and larger. Capsules and tablets require 300,000 units total, counted across the order rather than per SKU. Powders, oral care, pet wellness and other formats are confirmed at quote.
What drives the cost of a dietary supplement manufacturing run?
Four things dominate: the actives, especially where a botanical is scarce or the extract ratio is high; the packaging, often the largest line on a liquid quote; the run size, since setup and cleaning are fixed costs spread across units; and the testing scoped into your specification.
How long does dietary supplement manufacturing take?
We do not publish a lead time, because the honest answer depends on your project. Packaging availability is usually the long pole, followed by raw material sourcing, whether your formula is catalog or custom, the testing scoped for release, and your artwork sign-off. You get a real date in the quote.
Can I get samples or a pilot batch before committing to production?
Yes. Formulation samples are prepared during development so you can assess taste, appearance and dose before anything reaches a production record. A pre-production or pilot batch can be scoped where the format and the project justify it. Both are agreed at quote stage rather than assumed.
Do you provide a Certificate of Analysis for every lot?
Yes. Every lot ships with a Certificate of Analysis issued against your agreed finished-product specification and tied to the lot number printed on the goods. It is per lot, not a one-time qualification document reused across a year of production. What appears on it is defined by your specification.
What is 21 CFR Part 111?
21 CFR Part 111 is the FDA current Good Manufacturing Practice regulation for dietary supplements. It governs personnel, the physical plant, equipment, production and process control, holding and distribution, returns, complaints and records. It applies to anyone who manufactures, packages, labels or holds a dietary supplement, brand owners included.
Who is responsible for cGMP compliance, the brand or the manufacturer?
Both, separately. We are responsible for manufacturing your product under Part 111 in our facility. You are responsible for your own Part 111 obligations as the label holder, including qualifying us as a supplier, holding your specification and COAs, and handling complaints. Our compliance does not transfer to you.
Do you perform identity testing on botanical raw materials?
Yes. Part 111 requires the identity of an incoming dietary ingredient to be confirmed before it is used, and incoming materials are held under quarantine until that is done. Because Bio-Botanica extracts its own botanicals, for many formulas that chain of custody starts at the plant material rather than a broker document.
What is NSF/ANSI 455-2 and do I need it?
NSF/ANSI 455-2 is a voluntary industry GMP standard for dietary supplements that some retailers use as a supplier qualification benchmark, separate from FDA registration. BioB is NSF GMP certified and manufactures in an FDA-registered facility. If your channel requires a specific scheme by name, raise it at quote stage so we can confirm what we can document.
Can I audit your facility?
Yes. Customer audits are welcome and are the most efficient way to complete your supplier qualification under Part 111. You can walk the facility in Hauppauge, review the quality system and see the batch documentation for your product. We will also answer a written quality questionnaire if a visit is not practical.
Do you run stability testing and set shelf life?
Stability work is scoped per project rather than included by default, because the protocol, the timepoints and the storage conditions carry real cost. If you need a supported shelf life or an expiration date on the label, tell us at quote stage and we will scope the study with you. We do not assign dates we have not supported.
What is the difference between private label and contract manufacturing?
Private label means putting your brand on an existing formulation from our catalog of 300-plus, already developed, specified and documented. Contract manufacturing means we make a formula specific to you, whether modified from a base or developed from scratch. Private label is faster and cheaper; contract manufacturing is differentiated.
Do I need a finished formula before contacting you?
No. Most brands arrive with a concept, a target dose or a competitor product rather than a formula. Our formulators and extraction chemists can build one, or point you at a catalog base that already does the job. Bring the concept, the volume and the channel, and we will tell you which pathway fits.
Get a dietary supplement manufacturing quote
Published minimums, US manufacturing, and botanical actives we make ourselves. Tell us the dosage form and the volume, and you get a real number and a real timeline.
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