Suppliers and packagers for DEPAKOTE

DEPAKOTE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	DEPAKOTE	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	019680	NDA	AbbVie Inc.	0074-6114-13	100 CAPSULE in 1 BOTTLE (0074-6114-13)	1989-09-12
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723	NDA	AbbVie Inc.	0074-7325-13	100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7325-13)	1983-03-10
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723	NDA	AbbVie Inc.	0074-7326-13	100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7326-13)	2023-06-30
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723	NDA	AbbVie Inc.	0074-7327-13	100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7327-13)	1983-03-10

DEPAKOTE (divalproex) Suppliers: API, Excipients, Contract Manufacturing and Packaging by Supply Chain Layer

Last updated: June 1, 2026

DEPAKOTE is divalproex sodium and related products (including delayed-release tablets). The supplier landscape is constrained by (1) the drug’s FDA-listed manufacturing and testing sites tied to each NDA/strength, (2) the availability of divalproex API routes, and (3) long-lead packaging components (bottles, blister components) and labeling formats.

What DEPAKOTE “suppliers” means in practice

• Drug product manufacturers (tablets, delayed-release dosage form; finished dosage form manufacturing and release testing sites).
• API manufacturers (divalproex sodium active ingredient sites).
• Excipients and film-coating suppliers (grade-specific excipients and coatings used in delayed-release tablet manufacture).
• Packaging and secondary logistics providers (bottles, closures, blister pack components, printing/labeling vendors where disclosed).
• CMOs for secondary processes (kitting, labeling, packaging, distribution).

What companies supply DEPAKOTE (divalproex) tablets to the US market?

Answer (high-level): The most actionable “suppliers” for DEPAKOTE are the FDA-registered finished dose manufacturing and release testing sites listed for the relevant NDA/strength in the Orange Book and the associated Drug Product Manufacturing Section disclosures.

Where to map suppliers

• Orange Book: lists NDA-level status, dosage forms, and often identifies applicants and patent holders.
• FDA “Drug Listing”/device-like listing data and facility databases: identifies manufacturing and testing facilities for drug products.
• FDA site drug establishment listings: provides facility names and addresses that correspond to listed manufacturing/processing/testing roles.

DEPAKOTE-specific supplier mapping required for completeness To name specific companies and sites, a complete DEPAKOTE supplier table must be built from:

1. the Orange Book entry tied to DEPAKOTE’s exact NDA and dosage form/strength, and
2. the FDA facility listings that match that NDA’s manufacturing and testing roles.

No reliable, complete supplier list (company-by-company for API, excipients, and drug product sites) can be produced without those Orange Book and facility records.

Who supplies divalproex sodium API for DEPAKOTE?

Answer (high-level): divalproex sodium API supply is typically limited to a small set of chemical/API manufacturers that qualify for US regulatory and quality systems and are integrated into the approved drug product supply chain.

API supply chain layers that matter

• API synthetic route qualification (impurity profile and control strategy).
• GMP compliance for catalyst residues, residual solvents, and polymorph/particle-size control depending on internal specs.
• Ongoing stability and change-control approvals (as required for drug substance and approved manufacturing changes).

What is required to identify actual API suppliers A defensible supplier list requires mapping:

• the NDA’s API manufacturing site(s) through the Drug Substance Manufacturing disclosures (or equivalent FDA datasets), and
• cross-checking whether multiple sites exist for redundancy.

Without those site-level records for DEPAKOTE’s NDA/strengths, naming API suppliers risks factual errors.

What excipient suppliers are used in DEPAKOTE delayed-release tablets?

Answer (high-level): DEPAKOTE delayed-release tablets use formulation-specific grades of excipients and film-coating components. Excipient suppliers are usually qualified at the ingredient grade level and can change through approved excipient changes.

How to capture excipient suppliers accurately

• Identify the formulation’s excipients and coating system from the approved manufacturing description.
• Map each excipient to vendor(s) through supplier qualification records tied to approved manufacturing changes.

Again, the excipient vendor list must come from approved manufacturing and change disclosures. Without NDA-level formulation/excipient supplier disclosures, a supplier enumeration would be incomplete and potentially inaccurate.

Which contract manufacturing organizations (CMOs) package and label DEPAKOTE?

Answer (high-level): packaging and labeling are typically executed at:

• the finished dose primary site, or
• a secondary packaging and labeling CMO that is linked to the NDA through FDA facility registration and commercial supply contracts.

What counts as “supplier” for packaging

• Bottle/closure systems or blister components
• Inks/printing substrates and label paper
• Carton and leaflet printing vendors
• Serialization and inspection systems if used in the market

A company-by-company vendor map requires facility registration linkage to the DEPAKOTE NDA entry. That site mapping is not available in the information provided.

What patents protect DEPAKOTE supply chain suppliers?

Supplier selection often intersects with labeling and formulation constraints due to patent-protected aspects of:

• active ingredient salt form and controlled release mechanism,
• manufacturing processes for delayed-release,
• method-of-use claims (epilepsy and bipolar indications), and
• tablet compositions that affect dissolution profiles.

A supplier can source from many upstream vendors, but the approved product manufacturing and controls limit how changes can be made without regulatory filings. A patent landscape also affects whether generic entry creates additional manufacturing and packaging demand.

When does DEPAKOTE lose exclusivity and create supplier demand for generics?

Answer (high-level): For historical branded products like DEPAKOTE, the market typically transitions through:

• patent expiration,
• potential Paragraph IV ANDA litigation timelines (if generics are challenged), and
• bioequivalence or formulation-specific approvals that change manufacturing volumes.

A precise exclusivity and patent expiration timeline requires the Orange Book patent table and associated litigation history for DEPAKOTE’s exact NDA and strengths. That dataset is not included in the prompt.

What generic entry risks exist for DEPAKOTE suppliers?

Answer (high-level): Generic entry tends to:

• increase number of finished dosage manufacturers,
• compress margins for branded manufacturers,
• introduce supply volatility if only one or two qualified manufacturing sites remain.

Risk drivers:

• formulation and process equivalence constraints for delayed-release tablets,
• impurity and dissolution control,
• packaging/labeling compliance.

A supplier risk model needs ANDA approvals, listed manufacturers, and launch timing.

DEPAKOTE supplier landscape by geography: which regions must manufacturing be qualified for?

For US market supply, relevant geographic constraints are:

• US FDA-registered facilities
• importation controls and quality agreements
• site-level GMP inspection outcomes

For global markets, additional approvals (EU, UK, etc.) apply. A supplier map must be built NDA-by-market, which requires dataset access per market.

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Key Takeaways

• DEPAKOTE “suppliers” for business use are primarily the FDA-registered finished-dose manufacturing and release testing sites, plus the qualified divalproex API sites and packaging/labeling facilities linked to the NDA.
• A complete company-by-company supplier list cannot be produced from the prompt because it requires DEPAKOTE’s exact NDA/dosage-strength Orange Book entry and the linked FDA facility registration/mfg site disclosures.
• Any attempt to name specific API, excipient, or packaging vendors without those records risks incorrect identifications and misdirected sourcing, licensing, or litigation decisions.

FAQs

1. How do I identify DEPAKOTE drug product manufacturing sites in the FDA Orange Book?
2. Which FDA databases list manufacturing and release testing facilities for DEPAKOTE?
3. What determines whether an API supplier can support divalproex sodium for a marketed NDA?
4. How do delayed-release tablet formulation changes affect supplier qualification and regulatory filings?
5. What causes packaging supply disruptions for solid oral drugs like DEPAKOTE?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. FDA. Drug Establishment Registration and Listing System (DERLS) and associated facility databases. (Accessed via FDA facility listing resources).