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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037	NDA	Citra Labs LLC	23731-6051-1	10 VIAL, SINGLE-USE in 1 CASE (23731-6051-1) / 30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	2003-08-26
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037	NDA	Citra Labs LLC	23731-6051-2	25 VIAL, SINGLE-USE in 1 CASE (23731-6051-2) / 30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	2003-08-26
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037	NDA	Citra Labs LLC	23731-6051-3	30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	2003-08-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

Voltaren, the brand name for diclofenac sodium, is a widely used nonsteroidal anti-inflammatory drug (NSAID). Sourcing of its active pharmaceutical ingredient (API) and key excipients is critical for consistent supply chain management and product quality. This analysis identifies significant suppliers and relevant regulatory considerations.

Who Supplies Diclofenac Sodium API?

The global market for diclofenac sodium API is served by a concentrated group of manufacturers, primarily located in India and China. These suppliers are subject to stringent quality controls and regulatory oversight from bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key API Manufacturers:
- Divi's Laboratories: A leading Indian API manufacturer with significant capacity for NSAIDs, including diclofenac sodium. Divi's facilities are regularly inspected by global regulatory authorities. [1]
- Laurus Labs: Another prominent Indian pharmaceutical company that produces a range of APIs. Laurus Labs has established a strong track record in regulated markets. [2]
- Granules India: Granules India manufactures multiple APIs and is a significant player in the global supply chain. Their diclofenac sodium production adheres to international pharmacopeial standards. [3]
- Teva Pharmaceutical Industries: While primarily known as a finished dosage form manufacturer, Teva also has API manufacturing capabilities and is a potential supplier.
- Chinese Manufacturers: Several Chinese pharmaceutical chemical companies are active in the diclofenac sodium API market. These include, but are not limited to, companies with FDA Drug Master Files (DMFs) and EMA Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs). Specific company names in this segment often fluctuate based on market demand and regulatory status.
Regulatory Compliance: Manufacturers must hold approved Drug Master Files (DMFs) in the U.S. and obtain CEPs in Europe to supply diclofenac sodium for regulated markets. Compliance with Good Manufacturing Practices (GMP) is mandatory. [4]

What Are the Primary Excipients for Voltaren Formulations?

Voltaren formulations, particularly oral tablets and topical gels, utilize several common excipients to ensure drug stability, bioavailability, and ease of administration. The selection and quality of these excipients are critical for the performance and safety of the final drug product.

Oral Dosage Forms (Tablets/Capsules):
- Fillers/Diluents: These add bulk to the formulation. Common examples include:
  - Lactose Monohydrate: A disaccharide often used in tablets. USP/NF and EP compliant grades are required.
  - Microcrystalline Cellulose (MCC): A widely used binder and filler.
  - Corn Starch: Another common diluent and disintegrant.
- Binders: These hold the tablet ingredients together. Examples include:
  - Povidone (PVP): Polyvinylpyrrolidone is a synthetic polymer used as a binder.
  - Hydroxypropyl Methylcellulose (HPMC): Used for binding and film coating.
- Disintegrants: These help the tablet break apart in the digestive tract. Examples include:
  - Croscarmellose Sodium: A modified cellulose that swells rapidly.
  - Sodium Starch Glycolate: A cross-linked starch that swells and disintegrates tablets.
- Lubricants/Glidants: These improve powder flow and prevent sticking during tablet compression.
  - Magnesium Stearate: A common lubricant.
  - Colloidal Silicon Dioxide: Acts as a glidant.
- Coating Agents: For film-coated tablets.
  - Hypromellose (HPMC): Forms the basis of many film coatings.
  - Titanium Dioxide: A white pigment used for opacity and color.
  - Macrogol (Polyethylene Glycol - PEG): Used as a plasticizer in coatings.
Topical Dosage Forms (Gels/Creams):
- Gelling Agents: Provide the gel structure.
  - Carbomers: Acrylic acid polymers that form clear gels upon neutralization.
  - Hydroxyethyl Cellulose (HEC): A nonionic polymer used to thicken aqueous solutions.
- Solvents/Co-solvents: Aid in dissolving diclofenac and promoting skin penetration.
  - Propylene Glycol: A humectant and solvent.
  - Ethanol: An anti-inflammatory and solvent.
  - Isopropanol: A solvent.
- Emulsifiers (for creams): Stabilize oil-in-water or water-in-oil emulsions.
  - Cetyl Alcohol: A fatty alcohol.
  - Stearyl Alcohol: Another fatty alcohol.
- Preservatives: Prevent microbial growth.
  - Parabens (e.g., Methylparaben, Propylparaben): Common antimicrobial preservatives.
  - Phenoxyethanol: A widely used broad-spectrum preservative.
- Emollients: Soften and moisturize the skin.
  - Medium-Chain Triglycerides.

What Are the Key Supplier Considerations?

Pharmaceutical companies sourcing API and excipients for Voltaren must prioritize reliability, quality, and regulatory compliance.

Supplier Qualification: A rigorous supplier qualification process is essential. This includes auditing manufacturing sites for GMP compliance, reviewing quality control data, and assessing supply chain security.
Regulatory Filings: Ensure suppliers have up-to-date DMFs or CEPs for API and meet pharmacopeial standards (USP/NF, EP, JP) for excipients. Changes in regulatory status can impact supply continuity.
Quality Agreements: Establish comprehensive quality agreements with all critical suppliers. These agreements detail responsibilities for quality control, change management, and issue resolution.
Supply Chain Resilience: Diversify supplier bases where feasible to mitigate risks associated with geopolitical instability, natural disasters, or single-source dependencies.
Cost Management: While quality and reliability are paramount, ongoing cost analysis and negotiation are critical for commercial viability.
Audits: Conduct regular audits of key suppliers to ensure ongoing adherence to GMP and quality standards.
Lead Times and Capacity: Understand supplier lead times and production capacities to ensure timely delivery and scale-up potential.

Who Manufactures Voltaren Finished Dosage Forms?

The brand Voltaren is owned by GSK (GlaxoSmithKline) in many regions. However, manufacturing of finished dosage forms can be conducted by GSK's internal facilities or through contract manufacturing organizations (CMOs). Furthermore, generic versions of diclofenac sodium products are manufactured by numerous pharmaceutical companies worldwide.

Primary Brand Owner:
- GSK (GlaxoSmithKline): Holds global rights for the Voltaren brand, overseeing its production and distribution.
Generic Manufacturers: A vast number of pharmaceutical companies produce generic diclofenac sodium tablets, capsules, and topical formulations. These include:
- Teva Pharmaceutical Industries.
- Sun Pharmaceutical Industries.
- Dr. Reddy's Laboratories.
- Mylan (now Viatris).
- Sandoz (Novartis).
- Major pharmaceutical companies in North America, Europe, and Asia.

The choice of CMO or internal manufacturing site for finished dosage forms will depend on factors such as existing infrastructure, regulatory approvals, capacity, and cost-effectiveness.

What Are the Regulatory Requirements for Diclofenac Sodium Products?

The approval and marketing of diclofenac sodium products are governed by strict regulatory frameworks in each target market.

U.S. FDA:
- API: Requires an approved DMF for diclofenac sodium API.
- Finished Dosage Form: Requires an Abbreviated New Drug Application (ANDA) for generic products, demonstrating bioequivalence to the reference listed drug. For new formulations or indications, a New Drug Application (NDA) is required. [5]
- Excipients: Must meet USP/NF monograph specifications and be sourced from GMP-compliant manufacturers.
European Medicines Agency (EMA):
- API: Requires a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) or an Active Substance Master File (ASMF).
- Finished Dosage Form: Requires a Marketing Authorisation Application (MAA). Generic applications rely on the principle of demonstrated bioequivalence. [6]
- Excipients: Must comply with the European Pharmacopoeia (EP) and be manufactured under GMP.
Other Regulatory Bodies: Similar requirements exist for Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and the Therapeutic Goods Administration (TGA) in Australia, among others.

Key considerations include stability testing, impurity profiling, dissolution testing, and adherence to current GMP standards.

Key Takeaways

Diclofenac sodium API is predominantly supplied by manufacturers in India and China, with regulatory compliance (FDA DMFs, EMA CEPs) being a critical differentiator.
Common excipients for oral and topical Voltaren formulations include fillers, binders, disintegrants, lubricants, gelling agents, solvents, and preservatives, all requiring adherence to pharmacopeial standards.
Supplier selection for both API and excipients must involve rigorous qualification, quality agreements, and ongoing audits to ensure supply chain integrity and product quality.
While GSK owns the Voltaren brand, generic diclofenac sodium products are manufactured by a wide array of global pharmaceutical companies.
Regulatory approval for diclofenac sodium products necessitates adherence to specific guidelines from agencies like the FDA and EMA, including approved API filings and bioequivalence studies for generics.

FAQs

What is the primary regulatory pathway for a generic diclofenac sodium product to be approved in the U.S.? A generic diclofenac sodium product requires an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA). This application must demonstrate bioequivalence to the approved reference listed drug and ensure the API used has an approved Drug Master File (DMF).
Are there any specific risks associated with sourcing diclofenac sodium API from China? While many Chinese manufacturers are GMP compliant and supply global markets, risks can include potential for fluctuating quality standards, intellectual property concerns, and complexities in regulatory oversight and enforcement compared to some other regions. Thorough due diligence and site audits are crucial.
What pharmacopeial standards must excipients for diclofenac sodium formulations meet? Excipients must generally meet the standards set forth in the relevant pharmacopeias for the target market, such as the United States Pharmacopeia/National Formulary (USP/NF) in the U.S., the European Pharmacopoeia (EP) in Europe, and the Japanese Pharmacopoeia (JP) in Japan.
How can a pharmaceutical company ensure the stability of its Voltaren finished drug product? Stability is ensured through rigorous stability testing programs conducted according to International Council for Harmonisation (ICH) guidelines. This involves testing the drug product under various environmental conditions (temperature, humidity, light) at different time points to establish its shelf life and recommended storage conditions. The quality and compatibility of both the API and excipients are foundational to product stability.
What is a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)? A CEP is a certificate issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM). It confirms that a specific substance (API) complies with the requirements of the relevant European Pharmacopoeia monograph. Holding a CEP facilitates the approval process for finished medicinal products within European Union member states and other countries that recognize it.

Citations

[1] Divi's Laboratories. (n.d.). API Products. Retrieved from https://www.divislabs.com/product-categories/api

[2] Laurus Labs. (n.d.). API Products. Retrieved from https://www.lauruslabs.com/products/api/

[3] Granules India. (n.d.). APIs. Retrieved from https://www.granulesindia.com/apis/

[4] U.S. Food & Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files-dmfs/drug-master-files-dmfs

[5] U.S. Food & Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs). Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas

[6] European Medicines Agency. (n.d.). Authorisation of medicines. Retrieved from https://www.ema.europa.eu/en/human-regulatory/authorisation/authorisation-medicines

Suppliers and packagers for VOLTAREN

VOLTAREN

Voltaren (Diclofenac Sodium) Active Pharmaceutical Ingredient and Excipient Suppliers