Suppliers and packagers for generic pharmaceutical drug: VALPROIC ACID

VALPROIC ACID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bionpharma	VALPROIC ACID	valproic acid	CAPSULE;ORAL	073484	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8205-39	30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8205-39)	2016-07-15
Bionpharma	VALPROIC ACID	valproic acid	CAPSULE;ORAL	073484	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0152-1	100 POUCH in 1 BOX, UNIT-DOSE (17856-0152-1) / 1 CAPSULE, LIQUID FILLED in 1 POUCH	2016-07-15
Bionpharma	VALPROIC ACID	valproic acid	CAPSULE;ORAL	073484	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-279-53	60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-53)	2016-07-15
Bionpharma	VALPROIC ACID	valproic acid	CAPSULE;ORAL	073484	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-279-60	90 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-60)	2016-07-15
Bionpharma	VALPROIC ACID	valproic acid	CAPSULE;ORAL	073484	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-279-70	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-70)	2016-07-15

Valproic Acid API Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

Valproic Acid (VPA), a broad-spectrum anticonvulsant and mood-stabilizing agent, is synthesized through established chemical processes. Its primary active pharmaceutical ingredient (API) manufacturing relies on a limited number of key suppliers globally. The market is characterized by established players with long-standing production capabilities and ongoing regulatory oversight.

Who are the Primary Manufacturers of Valproic Acid API?

Key manufacturers of Valproic Acid API are concentrated in specific regions, primarily India and China, with some European presence. These companies operate under strict quality control measures and adhere to international regulatory standards such as Good Manufacturing Practices (GMP).

• Jubilant Pharmova Limited (India): A significant global supplier of VPA, with substantial manufacturing capacity. Their facilities are US FDA-inspected and hold numerous international certifications.
• Granules India Ltd. (India): Another major Indian producer with a strong portfolio of APIs, including VPA. They emphasize backward integration and cost efficiency.
• IOL Chemicals and Pharmaceuticals Ltd. (India): A leading manufacturer of bulk drugs and specialty chemicals, IOLCP is a notable supplier of VPA. Their production facilities are compliant with global regulatory requirements.
• Solvay S.A. (Belgium): While Solvay has historically been a significant producer, their divestments and focus shifts may impact future supply dynamics. Their European manufacturing base offers an alternative to Asian suppliers.
• Other Asian Manufacturers: Several other Chinese and Indian companies, such as Nanjing Pharmaceutical Factory (China) and various smaller producers, contribute to the global supply, often serving regional markets or acting as secondary suppliers.

The manufacturing process for VPA typically involves the reaction of diethyl malonate with sodium ethoxide, followed by alkylation with a propyl halide, and subsequent hydrolysis and decarboxylation. The purity and quality of the final API are critical for pharmaceutical formulations.

What is the Regulatory Status of Valproic Acid Manufacturing?

Valproic Acid API manufacturing is subject to rigorous regulatory scrutiny by health authorities worldwide. Compliance with GMP is mandatory for all API producers supplying to regulated markets like the United States, Europe, and Japan.

• US Food and Drug Administration (FDA): Manufacturers supplying VPA to the US market must comply with FDA regulations, including facility inspections and adherence to current Good Manufacturing Practices (cGMP). Facilities are regularly audited by the FDA.
• European Medicines Agency (EMA): For the European market, API manufacturers must meet the EMA's GMP standards. Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) are often required.
• Other National Regulatory Bodies: Agencies in Japan (PMDA), Canada (Health Canada), and other countries have their own specific requirements.

The regulatory landscape includes stringent impurity profiling and control. Analytical methods employed for quality control must be validated and comply with pharmacopoeial standards (e.g., USP, EP, JP). Changes in manufacturing processes, suppliers, or facilities require regulatory notification and, in some cases, re-approval.

What are the Key Raw Materials and Intermediates for Valproic Acid Production?

The synthesis of Valproic Acid relies on specific chemical precursors. The availability and cost of these raw materials can impact the overall supply chain stability and pricing of VPA.

• Diethyl Malonate: A primary ester used in the malonic ester synthesis route.
• Sodium Ethoxide: A strong base essential for deprotonating diethyl malonate.
• Propyl Halides (e.g., 1-Bromopropane, 1-Chloropropane): Alkylating agents used to introduce the propyl group.
• Sodium Hydroxide or Potassium Hydroxide: Used for hydrolysis.
• Acids (e.g., Sulfuric Acid): Used for decarboxylation and neutralization steps.

Suppliers of these key raw materials are often integrated into the chemical industry supply chain, with a global distribution network. Disruptions in the supply of any of these components, due to geopolitical events, environmental regulations, or production issues, can lead to VPA supply chain vulnerabilities.

What are the Major Pharmaceutical Companies Utilizing Valproic Acid API?

Numerous pharmaceutical companies across the globe formulate and market finished dosage forms of Valproic Acid. These companies rely on a consistent and high-quality supply of the API from approved manufacturers.

• AbbVie Inc. (USA): Through its acquisition of Allergan, AbbVie markets Depakote (delayed-release oral VPA), a widely prescribed medication for epilepsy and bipolar disorder.
• Teva Pharmaceutical Industries Ltd. (Israel): A major generic pharmaceutical company that manufactures and markets various VPA formulations, including generic versions of Depakote.
• Lannett Company, Inc. (USA): Another significant player in the generic market, offering VPA tablets and capsules.
• Sun Pharmaceutical Industries Ltd. (India): A global pharmaceutical giant that produces a wide range of generic and branded VPA products.
• Pfizer Inc. (USA): While not a primary VPA molecule holder, Pfizer may be involved in the distribution or formulation of products containing VPA through its subsidiaries or partnerships.
• Bayer AG (Germany): Historically, Bayer has had products containing VPA, and continues to be a presence in related therapeutic areas.

These pharmaceutical companies maintain robust quality assurance programs for their API suppliers, including regular audits and testing of incoming materials. Contract manufacturing organizations (CMOs) also play a role in the formulation and packaging of VPA-based drugs.

What is the Projected Market Trend for Valproic Acid API?

The market for Valproic Acid API is influenced by factors such as the prevalence of epilepsy and bipolar disorder, generic competition, regulatory changes, and the introduction of alternative therapies.

• Stable Demand: The established therapeutic applications of VPA for epilepsy and bipolar disorder ensure a consistent demand for the API.
• Genericization Impact: The expiration of patents on branded VPA formulations has led to significant generic competition, increasing the demand for cost-effective API from multiple suppliers.
• Regulatory Scrutiny: Increased regulatory focus on impurity control and quality standards may lead to consolidation among API manufacturers, favoring those with robust compliance systems.
• Geographic Shifts: While India and China remain dominant manufacturing hubs, efforts to diversify supply chains may lead to increased interest in alternative manufacturing locations.
• Therapeutic Advancements: The development of novel treatments for epilepsy and bipolar disorder could potentially impact the long-term demand for VPA, although its established efficacy and affordability position it for continued use.

The market is characterized by price sensitivity, particularly in the generic segment. Manufacturers who can achieve economies of scale and maintain high-quality, compliant production are best positioned.

Key Takeaways

• Global Valproic Acid API manufacturing is dominated by a select group of Indian and Chinese companies, with a smaller European presence.
• Regulatory compliance, particularly with cGMP standards from the FDA and EMA, is a critical prerequisite for market access.
• The synthesis of Valproic Acid relies on a standard set of chemical raw materials, the consistent supply of which is vital.
• Major pharmaceutical companies, both branded and generic, are the primary purchasers of Valproic Acid API for finished dosage forms.
• Market trends indicate stable demand driven by chronic disease prevalence, with price competition and stringent regulatory oversight shaping the supply landscape.

FAQs

1. What is the primary chemical synthesis route for Valproic Acid API? The most common synthesis route involves the malonic ester synthesis, beginning with diethyl malonate and proceeding through alkylation with a propyl halide, followed by hydrolysis and decarboxylation.

2. Are there any significant supply chain risks associated with Valproic Acid API production? Risks include potential disruptions in the supply of key raw materials (e.g., diethyl malonate, propyl halides), geopolitical instability affecting manufacturing regions, and stringent regulatory enforcement that could lead to plant shutdowns or recalls.

3. How does the pricing of Valproic Acid API compare between major manufacturers? Pricing is largely determined by production volume, manufacturing efficiency, raw material costs, and the level of regulatory compliance and quality certifications achieved. Indian and Chinese manufacturers often compete aggressively on price due to scale and cost advantages.

4. What are the typical impurity profiles monitored for Valproic Acid API? Key impurities monitored include residual starting materials, intermediates, process-related impurities (e.g., isomers, related acids), and potential degradation products. Regulatory guidelines specify acceptable limits for these impurities.

5. Does Solvay still have a significant presence in the Valproic Acid API market? While historically a major player, Solvay's strategic focus and portfolio adjustments may have altered their direct involvement. Companies seeking VPA API should verify current manufacturing and supply commitments directly with Solvay or its successors.

Citations

[1] Jubilant Pharmova Limited. (n.d.). Active Pharmaceutical Ingredients. Retrieved from https://www.jubilantpharmova.com/products/api/

[2] Granules India Ltd. (n.d.). Products. Retrieved from https://www.granulesindia.com/products/

[3] IOL Chemicals and Pharmaceuticals Ltd. (n.d.). APIs. Retrieved from https://www.iolcp.com/apis

[4] U.S. Food and Drug Administration. (n.d.). Guidance for Industry, Drug Master Files. Retrieved from https://www.fda.gov/

[5] European Medicines Agency. (n.d.). Active substances. Retrieved from https://www.ema.europa.eu/

[6] AbbVie Inc. (n.d.). Depakote Product Information. Retrieved from https://www.rxabbvie.com/

[7] Teva Pharmaceutical Industries Ltd. (n.d.). Product Catalog. Retrieved from https://www.tevapharm.com/

[8] Sun Pharmaceutical Industries Ltd. (n.d.). Product Portfolio. Retrieved from https://www.sunpharma.com/