FORFIVO XL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Twi Pharms	FORFIVO XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022497	NDA	Upsher-Smith Laboratories, LLC	24979-247-06	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-247-06)	2023-12-15
Twi Pharms	FORFIVO XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022497	NDA AUTHORIZED GENERIC	Upsher-Smith Laboratories, LLC	24979-248-06	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-248-06)	2023-12-15
Twi Pharms	FORFIVO XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022497	NDA AUTHORIZED GENERIC	Alvogen Inc.	47781-637-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-637-30)	2018-09-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

FORFIVO XL is a prescription medication primarily utilized in the treatment of major depressive disorder (MDD). Marketed by Supernus Pharmaceuticals, Inc., FORFIVO XL contains the active ingredient bupropion hydrochloride, formulated as an extended-release tablet. As a novel, once-daily formulation, it offers an alternative to traditional antidepressant treatments, emphasizing patient compliance and consistent plasma drug levels. The supply chain for FORFIVO XL involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulation developers, packaging entities, and distribution channels. This analysis examines the key suppliers involved in the production and distribution of FORFIVO XL, their roles, and market implications.

1. Active Pharmaceutical Ingredient (API) Suppliers

Bupropion Hydrochloride API

At the core of FORFIVO XL’s manufacturing process is the supply of bupropion hydrochloride—the active pharmaceutical ingredient (API). The API's quality, sourcing, and production directly influence the efficacy, safety, and regulatory compliance of the finished product.

Global API Manufacturers

Major API producers of bupropion hydrochloride include multinational pharmaceutical chemical companies with facilities adhering to Good Manufacturing Practices (GMP). Key players include:
- Tapi TBD: While specific API manufacturers for bupropion hydrochloride are often undisclosed due to commercial confidentiality, prominent suppliers include companies like Mylan, Teva Pharmaceuticals, and generic API producers such as Zhejiang Hoshine Silicon Industry Co., Ltd., and Zhejiang Medicine Co., Ltd., which have capacity to produce bulk APIs at scale.
- Regulatory Status: Many of these API manufacturers hold approvals from regulatory agencies (FDA, EMA) or are approved for export to regulated markets, ensuring quality assurance for finished product manufacturing.
Supplier Selection and Qualification

Manufacturers of FORFIVO XL typically seek API suppliers with proven quality track records, consistent supply capabilities, and competitive pricing. These API sources often undergo rigorous qualification, including on-site audits, stability testing, and verification of GMP compliance.

2. Contract Manufacturing and Formulation Suppliers

Formulation of Forfivo XL

Supernus Pharmaceuticals manages product formulation and packaging, often collaborating with Contract Manufacturing Organizations (CMOs) specialized in solid oral dosage forms.

Key CMOs

Several pharmaceutical manufacturing firms globally serve as CMOs for extended-release formulations:
- Catalent Pharma Solutions: Known for expertise in controlled-release formulations and unit-dose packaging. Catalent’s facilities in the US and Europe are certified for high-quality pharma production.
- Patheon (a Thermo Fisher Scientific company): Offers formulation, manufacturing, and packaging, with capabilities specific to complex formulations such as extended-release systems.
- Recipharm: Provides manufacturing services for sustained-release tablets using advanced technologies, ensuring batch-to-batch consistency.
Formulation Technologies

Forfivo XL employs an extended-release matrix technology, likely utilizing hydrophilic matrix systems or osmotic systems. CMOs specializing in such technologies optimize stability, bioavailability, and controlled drug release profiles.

3. Packaging and Labeling Suppliers

Efficient supply depends on precise packaging solutions aligned with regulatory requirements.

Packaging Material Suppliers

Suppliers of blister packs, bottles, desiccants, and labeling components include:
- Gerresheimer: Supplies pharmaceutical-grade plastic containers, blisters, and closures.
- West Pharmaceutical Services: Provides sealing membranes, active blister packs, and tamper-evident features.
Labeling and Serialization

With increasing regulatory demands for track-and-trace systems, suppliers like Smart ID Technologies or Xavier Technologies enable serial coding, QR codes, and anti-counterfeit measures.

4. Distribution and Logistics Partners

After manufacturing, the finished product’s distribution hinges on reliable logistics providers.

Wholesale Distributors

Major pharmaceutical distributors—such as McKesson, Cardinal Health, and AmerisourceBergen—are responsible for warehousing, inventory management, and distribution to retail pharmacies, hospitals, and clinics.
Third-Party Logistics (3PL) Providers

Specialized 3PL companies like DHL Supply Chain, UPS Healthcare, and FedEx Custom Critical offer cold chain management, international shipping, and real-time tracking, ensuring the stability and security of the supply chain.

5. Regulatory and Quality Assurance Agencies

While not suppliers per se, agencies such as the FDA and EMA oversee the manufacturing compliance and licensing of suppliers involved in the FORFIVO XL supply chain. Their inspections and approvals influence the choice of suppliers and the integrity of the product pipeline.

Market Implications and Supply Chain Considerations

Global Sourcing: The reliance on a network of API manufacturers across Asia, Europe, and North America amplifies risks related to geopolitical tensions, supply disruptions, and regulatory divergences.
Supply Security: Limited number of API manufacturers for proprietary formulations like FORFIVO XL can impact supply continuity, especially amidst manufacturing disruptions or regulatory actions.
Regulatory Oversight: Ensuring supplier GMP compliance and robust quality management systems aligns with FDA and international standards, critical for maintaining market access.
Future Outlook: Supernus Pharmaceuticals might diversify or vertically integrate by developing in-house API production or establishing multiple vendor relationships to mitigate supply chain vulnerabilities.

Key Takeaways

FORFIVO XL’s supply chain is intricate, relying heavily on high-quality API inputs, specialized formulation CMOs, and a dependable distribution network.
The primary API manufacturer for bupropion hydrochloride is a critical node, with suppliers often sourced from established global API producers compliant with regulatory standards.
The industry's shift toward globalization necessitates vigilant supplier qualification, regulatory audits, and supply chain resilience planning.
As demand for effective depression treatments rises, ensuring uninterrupted supplies will depend on maintaining diversified supplier relationships and strategic inventory management.
Transparency in the supply chain enhances regulatory compliance and product integrity, essential for market confidence in FORFIVO XL.

FAQs

Q1: Who are the main API suppliers for bupropion hydrochloride used in FORFIVO XL?
A1: While specific supplier identities are confidential, prominent API producers globally include companies in China, India, and Europe, such as Zhejiang Hoshine and Zhejiang Medicine, who meet stringent GMP standards.

Q2: Do manufacturers of FORFIVO XL produce the drug domestically or internationally?
A2: Supernus Pharmaceuticals primarily handles formulation, often partnering with international CMOs. API sourcing is from global suppliers, emphasizing a mixed domestic and international supply chain.

Q3: How do supply chain disruptions impact the availability of FORFIVO XL?
A3: Disruptions in API supply, manufacturing delays, or regulatory issues can lead to shortages, affecting patient access and treatment continuity.

Q4: Are there alternatives to FORFIVO XL in the market?
A4: Yes. Other bupropion-based formulations include Wellbutrin XL (GlaxoSmithKline) and generic bupropion ER products, serving as alternatives, though each varies in release mechanism and dosing.

Q5: What steps are taken to ensure the quality of suppliers involved in the FORFIVO XL supply chain?
A5: Supernus verifies GMP compliance through supplier audits, quality agreements, and ongoing validation processes to ensure API and formulation standards meet regulatory and safety requirements.

References

Supernus Pharmaceuticals, Inc.. (2022). FORFIVO XL Product Monograph.
U.S. Food and Drug Administration (FDA). API Supplier Verification Program.
Pharmaceutical Technology. Top API Manufacturers and Suppliers.
Contract Pharma. Leading Contract Manufacturing Organizations in Pharma Industry.
World Health Organization (WHO). Good Manufacturing Practices for pharmaceutical products.

Suppliers and packagers for FORFIVO XL

FORFIVO XL

Suppliers for the Pharmaceutical Drug: FORFIVO XL