DEPAKOTE ER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168	NDA	AbbVie Inc.	0074-7401-13	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7401-13)	2000-08-04
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168	NDA	AbbVie Inc.	0074-7402-13	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7402-13)	2000-08-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

DEPAKOTE ER (divalproex sodium extended-release) suppliers: active ingredient, manufacturing, and secondary sources

Executive summary: DEPAKOTE ER (divalproex sodium extended-release) is sourced through upstream valproate supply chains (valproic acid and related intermediates) and down the chain through contract manufacturing for oral solid dosage manufacturing and packaging. The supplier set is typically split across (1) active pharmaceutical ingredient (API) producers for divalproex sodium and (2) finished-dose manufacturers and packaging sites for ER tablets. Identify the exact current DEPAKOTE ER manufacturing and packaging sites by cross-referencing the FDA Orange Book “Drug Product” listing (TE codes/manufacturing sites) and the latest FDA establishment inspection records tied to the label.

What companies supply the active pharmaceutical ingredient (API) for DEPAKOTE ER?

Featured snippet answer: DEPAKOTE ER’s API is divalproex sodium. The API supplier list is determined by the FDA Orange Book drug product listing and current NDA/ANDA labeling manufacturing sites, then mapped upstream to divalproex sodium/API producers via registration, DMF status, and inspection records.

API supply chain inputs for divalproex sodium

Divalproex sodium manufacture depends on upstream availability of valproic acid and related intermediates (chemical intermediates and purification steps), with typical industrial controls around halogen impurities, residual solvents, and endotoxin-free process requirements for final oral solid manufacture (for drug products).

How to translate DEPAKOTE ER label and Orange Book listings into API suppliers

The fastest defensible supplier approach for business due diligence is:

Pull the Orange Book “Drug Product” listing for DEPAKOTE ER, including the labeled manufacturer/labeler and the dosage form and strength for the ER tablets.
Use the labeled manufacturing/packaging sites to identify contract or affiliate plants.
Trace the upstream API via:
- DMF-linked API manufacturing sites (where disclosed in regulatory documents),
- FDA establishment inspection history tied to API manufacture,
- supply chain statements in regulatory filings where available.

What contract manufacturers make and package DEPAKOTE ER tablets?

Featured snippet answer: Finished-dose DEPAKOTE ER is produced and packaged at one or more labeled manufacturing and packaging sites. Those sites appear on the product label and Orange Book listing for the specific strength and dosage form.

What to check on the label for supplier identification

For contract-manufacturing and packaging due diligence, the label typically identifies:

Manufactured for / Distributed by (corporate labeler)
Manufactured at sites (tablet production and conditioning)
Packaged at sites (bottling or blister packaging depending on presentation)
Any site-specific identifiers that correspond to FDA establishment registrations

Why ER tablet production changes the supplier set

Extended-release tablet supply depends on:

controlled-release excipient systems,
tablet press parameters and coating processes (for ER profile),
stability qualification for the release-determining layers.

Those requirements increase reliance on specialized solid-dose CMOs with ER coating and process controls, compared with immediate-release valproate products.

Which suppliers handle bulk divalproex sodium for extended-release formulations?

Featured snippet answer: Suppliers for bulk divalproex sodium are generally the same upstream API producers used for multiple divalproex sodium presentations, but the ER finished-dose plants select based on qualification of API particle size, impurity profile, and release-critical performance.

Qualification criteria that narrow the supplier pool

ER tablets often require tight control over:

API polymorphic form and particle size distribution,
residual solvents and process impurities,
water content and flow properties impacting blending and coating uniformity.

These criteria drive multi-year qualification cycles and can restrict switching of API suppliers without bridging stability batches.

How many suppliers are in the DEPAKOTE ER supply chain and how is it structured?

Featured snippet answer: The effective supplier set usually comprises multiple upstream API sources (often 2+ qualified suppliers) feeding one or more finished-dose manufacturing plants, with separate packaging suppliers for bottles or blister packs.

Typical structure (commercial reality for oral solid ER)

API: divalproex sodium from one or more API manufacturing sites
Finished dosage: one or more tablet manufacturing plants producing ER coating/press/blend steps
Packaging: dedicated pack-out sites (bottling and cartonization) listed on Orange Book and label

What is the FDA Orange Book status of DEPAKOTE ER, and how does it show manufacturing suppliers?

Featured snippet answer: The Orange Book listing for DEPAKOTE ER identifies the NDA holder, drug product details, and manufacturing/labeler information that maps to FDA-registered establishment sites.

How Orange Book listings are used for supplier confirmation

Orange Book provides the drug product entry by strength and dosage form
It typically includes the labeler and manufacturer attribution per listing entry
For supplier verification, each Orange Book listing must be matched to:
- the product presentation on the market (bottle vs blister, NDC mapping),
- the label’s manufacturing/packaging site text,
- the FDA establishment registration associated with that site.

Which finished-dose manufacturers are responsible for DEPAKOTE ER for each strength?

Featured snippet answer: Responsibility varies by strength and package configuration and must be tied to the exact NDC/strength entry in Orange Book and the label.

Strength-specific supplier mapping

In practice, a single labeler can source multiple strengths from different plants. ER tablet equipment constraints and capacity planning often lead to:

different manufacturing plants for 250 mg vs 500 mg vs 750 mg,
different packaging sites for different pack formats.

This is why supplier due diligence should use NDC-level mapping, not only the branded product name.

What manufacturing/IP barriers limit switching DEPAKOTE ER suppliers?

Featured snippet answer: The main barriers are release-critical formulation and process parameter qualification, ER coating reproducibility, and stability bridging requirements tied to NDA changes.

Key technical constraints

ER release profile depends on excipient system and process controls
API switching triggers impurity and performance bridging
Site transfers require validation batches and regulatory reporting

Key business constraints

long qualification and contracting cycles,
capacity lock-in for ER tablet coating lines,
supply risk management tied to valproate market dynamics.

How do supplier changes affect DEA/controlled substance constraints and distribution?

Featured snippet answer: Supplier identification does not directly change DEA scheduling for valproates in the US, but distribution is affected by:

pharmacy allocation practices during shortage periods,
wholesaler channel requirements tied to manufacturing site.

If a shortage occurs, supply chain substitutions can shift bottle/labeling inventory among pack formats even when the API remains qualified.

What generic or biosimilar risk exists for DEPAKOTE ER that could change supplier sourcing?

Featured snippet answer: The supplier set for DEPAKOTE ER can tighten during generic competition or enforcement actions only if new manufacturing demand changes allocation, but the core supply chain for valproate ER is driven by the NDA/brand holder’s manufacturing strategy and regulatory constraints tied to equivalent release.

Paragraph IV challenges and supplier implications

Even when generics are approved, brand manufacturing supplier switching is not automatic. Typically:

the brand maintains qualified supply to protect supply continuity,
any site changes require NDA reporting and validation.

Competitive landscape: do suppliers overlap with other divalproex products (IR vs ER)?

Featured snippet answer: Upstream API suppliers can overlap across divalproex products, while ER finished-dose plants are usually more specialized due to extended-release coating and release profiling.

Overlap pattern

API: common
Immediate-release tablet production: less ER-specific equipment
ER tablet production: ER coating and controlled-release blend processes

Key Takeaways

DEPAKOTE ER’s supplier chain splits into upstream divalproex sodium API sources and downstream finished-dose manufacturing and packaging sites.
The most reliable way to identify the current supplier set for business use is Orange Book + NDC-level label mapping, then verify the mapped manufacturing sites against FDA establishment registration and inspection records.
ER tablets increase the number of qualification and process barriers, which narrows the viable set of finished-dose suppliers and slows switching.
Supplier responsibility can be strength- and presentation-specific, so supplier identification should be done at the NDC/strength level rather than only by brand name.

FAQs

How do I find DEPAKOTE ER manufacturing sites from the Orange Book? Use the DEPAKOTE ER drug product listing and match the specific strength and presentation to the listing entries that include manufacturer/labeler site attribution.
Can the API supplier for divalproex sodium change for DEPAKOTE ER? Yes, but switching is constrained by impurity profile and ER performance qualification requirements and requires regulatory reporting.
Do packaging suppliers differ from tablet manufacturing suppliers for DEPAKOTE ER? Yes. Pack-out for bottles vs blisters commonly uses separate FDA-registered packaging sites.
What causes DEPAKOTE ER supply constraints at the supplier level? ER tablet coating line capacity, qualified API availability, and stability/validation constraints tied to maintaining the release profile.
Do generic divalproex ER approvals automatically change brand suppliers? No. Brand manufacturing is governed by qualification and NDA change controls; generic entry mainly affects commercial allocation rather than forcing brand supplier swaps.

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
FDA. Drug Establishment Registration and Drug Listing (DEDR). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-establishment-registration-and-drug-listing

Suppliers and packagers for DEPAKOTE ER

DEPAKOTE ER