Dietary supplement contract manufacturing · Hauppauge, New York
Dietary Supplement Manufacturer
A US dietary supplement manufacturer with published minimum order quantities, 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 minimum order quantities, not “available on request”. 5,000 units for liquids and personal care, 300,000 for capsules and tablets.
- We make the botanical extracts, sourced globally and made in New York, in the same building as your finished goods.
- One FDA-registered US site. No import exposure, no offshore quality gap.
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No obligation.
NSF GMP certified
FSSC 22000
FDA-registered facility
USDA Organic
Kosher
Halal
Botanicals sourced globally
Extracts made in New York since 1972
1972
Extracting botanicals since
160,000
Sq ft FDA-registered facility
5,000
Unit minimum order quantity, liquids and personal care
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.
Browse liquid supplements →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.
Browse alcohol-free liquids →Capsules
Capsule supplements at production scale, including formulas using our own botanical extracts. Minimum order quantity 300,000 units total across the order.
Browse capsule supplements →Tablets
Tablet supplements at production scale, minimum order quantity 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. Minimum order quantities 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.
Browse oral care →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 | Minimum order quantity | 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 | Applies to 8 oz and 16 oz fills. |
| 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?
About 12 weeks from approved formula and packaging to finished goods. The variable is almost always packaging component availability rather than manufacturing capacity. Five things move yours. Packaging is 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. 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 formula from our proven private label catalog of more than 300, formulas already in the market through other brands. Semi-custom modifies one of those bases. Development from a benchmark or specification you provide builds a formula to it. Speed, cost and differentiation move in opposite directions across the three.
Private label
Pick from 300+ formulations in our proven private label catalog, 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.
Browse all products →Semi-custom
Start from a catalog base and change what matters: swap or add a botanical extract, adjust an ingredient level, move from ethanol to alcohol-free, redirect the flavor. Genuinely yours, without full development time.
Development from a benchmark or specification
Development with our formulators and extraction chemists from a benchmark product or a specification you provide. You bring the target and the botanical ingredients you want to lead with; we build the formula, the specification and the manufacturing record.
Why does it matter that we make our own botanical extracts?
Because the botanical extract is the part of a botanical supplement most likely to go wrong, and most contract manufacturers buy theirs from a broker. Bio-Botanica has made botanical extracts, sourced globally and made in New York, 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 extracts 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.
For ingredients we do not make ourselves, such as vitamins, minerals, amino acids and specialty botanicals, you buy through Bio-Botanica’s purchasing volume rather than your own. That means volume pricing on raw materials from the first run, qualified suppliers already on file, and one quality system covering both the extracts we make and the ingredients we source.
We do not white label. Every lot is made fresh to order.
White label means pre-made stock on a shelf waiting for a label. We do not keep one. Your product is manufactured when you order it, so it ships with its full shelf life, every repeat run is made to the same specification, and nothing you sell has been sitting in someone else’s warehouse. It is one of the reasons retailers and marketplaces accept our documentation without a second look.
What happens from first call to shipped lot
Six steps, about 12 weeks from approved formula and packaging to finished goods. The order never changes; what moves the date is how much of the specification already exists when you arrive and how quickly packaging components can be secured.
1
Scope call
Product, format, volume and timing. We tell you plainly whether our minimum order quantities fit your plan and whether private label or custom is the right route.
2
Formula
Choose a formulation from our proven private label catalog, or we review the specification you bring and develop one to your benchmark.
3
Preliminary quote
Pricing, minimum order quantities, components and lead time, so you know the numbers before anyone makes a sample.
4
Samples and specification sign-off
You assess samples until you approve. The finished-product specification and the test panel are fixed in writing here. Nothing scales until the sample is the product you want to sell.
5
Label and artwork review
You supply the artwork. We supply the ingredient and specification data it has to reflect, and check the printed panel against the actual product before the run.
6
Production, QC release and documentation
Manufacture under NSF GMP, release against the agreed specification, and ship from New York with the Certificate of Analysis and documentation package for the lot. Repeat runs start at step five unless the specification has changed.
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 and FSSC 22000 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.
| Responsibility | BioB Manufacturing | You, the brand owner |
|---|---|---|
| Manufacturing under Part 111 | Operates the GMP quality system, batch records and production controls at our facility | Not required to operate a plant, but still a manufacturer under Part 111 by virtue of holding the label |
| Specification | Provides the finished-product specification and manufactures to it | Reviews and formally accepts the specification as the definition of your product |
| Certificate of Analysis | Issues a COA for every lot against the agreed specification | Under §111.75, must not rely on that COA alone — confirm it with your own testing and document why the supplier is qualified |
| Supplier qualification | Supplies the certification, facility and specification evidence you need to build the file | Performs and documents the qualification, and reconfirms it periodically |
| Label content and claims | Supplies the ingredient and specification data the panel must reflect; reviews artwork against the product | Owns the finished label, the claims made on it, and the substantiation behind them |
| Adverse event reporting | Supports investigation with batch and production records | Holds the reporting obligation as the firm whose name is on the label |
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.
We cannot do your supplier qualification for you — the regulation deliberately puts it on you. What we can do is make it short: published certifications, a specification you receive before production rather than after, a COA on every lot, and a straight answer when your quality consultant emails with a question.
Why brands choose BioB Manufacturing
We manufacture in the United States, we make the botanical extracts, and we put our minimum order quantities and our obligations in writing before you speak to a salesperson. The US dietary supplement contract manufacturing market was valued at USD 6.65 billion in 2025 and is projected to reach USD 16.6 billion by 2033, a 12.2% CAGR, per Grand View Research. No shortage of manufacturers; a shortage of straight answers.
We make the botanical extracts
Botanical extraction in house since 1972, in the same building as the filling line. Sourced globally, made in New York, so traceability starts with us, not a broker.
Made fresh to order
No white label stock. Every lot is manufactured when you order it and ships with its full shelf life.
Minimum order quantities in print
5,000 units for liquids and personal care, 2,500 for liquids 8 oz and larger, 300,000 for capsules and tablets. Qualify us in a minute, not after three calls.
One US site
A single 160,000 sq ft FDA-registered facility in New York. No import step, no tariff variable, no offshore transit between you and a stockout.
Supplements and personal care together
Liquids, capsules, tablets, powders, oral care and pet wellness alongside serums, creams, lotions and sprays. One vendor, one quality system, one documentation package.
We tell you what you own
The 21 CFR Part 111 responsibility split is on this page, before the quote. You should know your obligations before you sign, not after.
Explore more of BioB Manufacturing
Dietary supplement manufacturing FAQ
What is the minimum order quantity for dietary supplement manufacturing?
Liquids and personal care start at 5,000 units for fills under 8 oz, and liquids 8 oz and larger start at 2,500 units. 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 botanical extracts, 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?
About 12 weeks from approved formula and packaging to finished goods. The variable is almost always packaging component availability rather than manufacturing capacity, followed by raw material sourcing, whether your formula is catalog or custom, the testing scoped for release, and your artwork sign-off. Tell us your on-shelf date and we will say whether it is reachable.
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 white label?
No. We do not keep pre-made stock waiting for a label. Every lot is manufactured to order, so your product ships with its full shelf life and every repeat run matches the same specification.
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 proven private label catalog of 300-plus, formulas already in the market through other brands, already developed, specified and documented. Contract manufacturing means we make a formula specific to you, whether modified from a base or developed to your benchmark or specification. 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 benchmark product, a specification or a target dose rather than a finished formula. Our formulators and extraction chemists build to it, or point you at a catalog base that already does the job. Bring the benchmark, the volume and the channel, and we will tell you which pathway fits.
Get a dietary supplement manufacturing quote
Published minimum order quantities, US manufacturing, and botanical extracts we make ourselves. Tell us the dosage form and the volume, and you get a real number and a real timeline.