Suppliers and packagers for MALARONE

MALARONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078	NDA	GlaxoSmithKline LLC	0173-0675-01	100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01)	2000-07-26
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078	NDA	GlaxoSmithKline LLC	0173-0675-02	24 TABLET, FILM COATED in 1 DOSE PACK (0173-0675-02)	2000-07-26
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078	NDA	GlaxoSmithKline LLC	0173-0676-01	100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01)	2000-07-26

Malarone Drug Substance and Finished Product Suppliers

Last updated: February 19, 2026

This analysis identifies and profiles key suppliers involved in the production of Malarone, a fixed-dose combination antimalarial drug. It details active pharmaceutical ingredient (API) manufacturers and contract manufacturing organizations (CMOs) responsible for the drug's formulation and packaging.

Who Supplies the Active Pharmaceutical Ingredients for Malarone?

The primary active pharmaceutical ingredients (APIs) for Malarone are atovaquone and proguanil hydrochloride. The manufacturing of these APIs is concentrated among a limited number of specialized chemical producers.

Atovaquone API Suppliers:

• Company: IOL Chemicals and Pharmaceuticals Ltd.

  • Location: Barnala, Punjab, India.
  • Key Information: IOL CP is a significant producer of APIs, including atovaquone. The company operates multiple manufacturing plants with a focus on sterile and non-sterile APIs. They have a documented history of supplying atovaquone to global markets. [1]
  • Capacity: While specific production volumes for atovaquone are not publicly disclosed, IOL CP's overall API production capacity is substantial, positioning them as a key player.
  • Regulatory Status: The company holds various international certifications, including US FDA, EDQM, WHO GMP, and others, indicating adherence to stringent quality standards.

• Company: Apeloa Pharmaceutical Co., Ltd.

  • Location: Hangzhou, Zhejiang, China.
  • Key Information: Apeloa is a diversified pharmaceutical company with a strong API manufacturing division. They are known to produce atovaquone and have a global reach. [2]
  • Capacity: Apeloa's API segment operates multiple production sites, contributing to their overall capacity for various therapeutic classes.
  • Regulatory Status: The company's facilities are compliant with GMP standards and have undergone inspections by international regulatory bodies.

Proguanil Hydrochloride API Suppliers:

• Company: Divi's Laboratories Limited

  • Location: Hyderabad, Telangana, India.
  • Key Information: Divi's Labs is a leading global manufacturer of APIs and intermediates. They produce proguanil hydrochloride at their Visakhapatnam facility. [3]
  • Capacity: Divi's Labs is recognized for its large-scale API production capabilities, particularly for high-volume generic APIs.
  • Regulatory Status: The company has a strong regulatory track record with approvals from US FDA, EDQM, and other major health authorities.

• Company: Granules India Limited

  • Location: Hyderabad, Telangana, India.
  • Key Information: Granules India is another significant API manufacturer with a portfolio that includes proguanil hydrochloride. They focus on backward integration and cost-effective manufacturing. [4]
  • Capacity: Granules India operates multiple manufacturing units designed for large-scale API production.
  • Regulatory Status: Their facilities comply with international GMP standards and have received approvals from regulatory agencies worldwide.

What Contract Manufacturing Organizations (CMOs) Produce Finished Malarone Dosage Forms?

The finished dosage form of Malarone, a tablet containing atovaquone and proguanil hydrochloride, is typically manufactured by contract manufacturing organizations (CMOs) or by the brand holder's own manufacturing facilities. Given the proprietary nature of many pharmaceutical supply chains, specific CMOs for Malarone are not always publicly disclosed. However, the general landscape involves companies with expertise in solid dosage form manufacturing.

Key CMO Capabilities Relevant to Malarone Production:

Companies involved in the finished product manufacturing of Malarone must possess capabilities for:

• Granulation: Wet or dry granulation of API blends.
• Tableting: High-speed tablet presses for accurate weight and hardness control.
• Coating: Film coating for taste masking, stability, and ease of swallowing.
• Packaging: Blister packing and bottle filling, often with serialization for track-and-trace requirements.
• Quality Control: Comprehensive in-process and finished product testing to meet pharmacopoeial standards.

Likely CMO Profile:

Based on industry practices, CMOs that would be qualified to manufacture Malarone tablets typically have experience with fixed-dose combination products and adhere to stringent GMP regulations. These entities are often large, multinational CMOs with a broad range of pharmaceutical manufacturing services.

• Example of a CMO Type: Thermo Fisher Scientific (through its Patheon brand)

  • Services: Offers comprehensive drug substance and drug product manufacturing, including solid dosage forms.
  • Global Network: Operates facilities across North America, Europe, and Asia, equipped for large-scale production.
  • Regulatory Compliance: Holds numerous global regulatory approvals.

• Example of a CMO Type: Catalent Pharma Solutions

  • Services: Specializes in drug development and manufacturing, with extensive capabilities in oral solid dose forms.
  • Technological Expertise: Utilizes advanced technologies for granulation, coating, and packaging.
  • Global Reach: Operates manufacturing sites in multiple countries.

• Example of a CMO Type: Recipharm AB

  • Services: A leading contract development and manufacturing organization (CDMO) providing services across the pharmaceutical value chain, including finished dose manufacturing.
  • Manufacturing Scale: Possesses capabilities for both small-scale and large-scale commercial production.
  • European Base: Strong presence in Europe, with expanding global operations.

While specific contracts for Malarone may be confidential, these types of organizations represent the caliber of manufacturing partners involved in producing established pharmaceutical products like Malarone.

What are the Regulatory Considerations for Malarone Supply Chain?

The supply chain for Malarone, encompassing API production and finished drug manufacturing, is subject to rigorous regulatory oversight by health authorities worldwide.

Key Regulatory Aspects:

• Good Manufacturing Practices (GMP): All manufacturing sites, for both APIs and finished products, must comply with GMP standards as defined by regulatory bodies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). [5]
• Drug Master Files (DMFs) / Active Substance Master Files (ASMFs): API manufacturers must file DMFs or ASMFs with regulatory agencies. These confidential documents provide detailed information about the API manufacturing process, quality control, and stability. [6]
• Site Inspections: Manufacturing facilities are subject to regular inspections by regulatory authorities to ensure ongoing compliance with GMP and other applicable regulations.
• Quality Agreements: Robust quality agreements between API suppliers, finished product manufacturers, and the brand holder are essential. These agreements define responsibilities for quality control, change management, and issue resolution.
• Pharmacopoeial Standards: APIs and finished products must meet the quality specifications outlined in official pharmacopoeias, such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.). [7]
• Traceability and Serialization: With increasing regulatory focus on supply chain security, manufacturers are required to implement serialization and track-and-trace systems to ensure product authenticity and prevent counterfeiting. [8]
• Import/Export Regulations: Compliance with international trade regulations, including customs declarations and import/export permits for pharmaceutical products and their components, is mandatory.

What is the Market Landscape for Malarone APIs and Finished Products?

The market for Malarone is primarily driven by its use in malaria prevention and treatment. As a combination therapy, its demand is influenced by malaria incidence rates, travel patterns to endemic regions, and public health initiatives.

API Market Dynamics:

• Generic Competition: While Malarone was originally patented by GlaxoSmithKline (GSK), patent expiries have opened the door for generic versions. This increases competition among API suppliers to offer cost-effective, high-quality atovaquone and proguanil hydrochloride.
• Price Sensitivity: The market for antimalarials, particularly in regions with high malaria burden, is often price-sensitive. This necessitates efficient and scalable API production processes.
• Geographic Concentration of API Production: A significant portion of global API manufacturing, including for antimalarials, is concentrated in India and China due to cost advantages and established manufacturing infrastructure.

Finished Product Market Dynamics:

• Brand vs. Generic: The market includes both the branded Malarone and its generic equivalents. Brand recognition and established distribution networks play a role, but price becomes a critical factor for generic adoption.
• Distribution Channels: Malarone is distributed through pharmacies, travel clinics, and governmental health programs. The effectiveness of these channels influences market penetration.
• Public Health Programs: Non-governmental organizations (NGOs) and governmental health organizations often procure antimalarials in large volumes for distribution in endemic areas. These entities are significant purchasers.
• Traveler Demand: A substantial segment of the market is driven by international travelers requiring malaria prophylaxis.

Competitive Factors:

• Cost of Goods: The ability of suppliers to produce APIs and finished products at competitive costs is paramount.
• Quality and Regulatory Compliance: Unwavering adherence to quality standards and regulatory requirements is non-negotiable. Any regulatory non-compliance can lead to product recalls and significant financial losses.
• Supply Chain Reliability: Consistent and reliable supply of both APIs and finished products is critical to meet market demand and prevent stockouts.
• Intellectual Property: While core patents may have expired, there can still be ongoing considerations related to formulation patents, manufacturing process patents, and trademarks.

Key Players in the Broader Market:

Beyond the direct API and CMO suppliers, the broader market for Malarone involves:

• Brand Holder: Historically, GlaxoSmithKline (GSK) has been the primary brand holder and marketer of Malarone. [9]
• Generic Manufacturers: Numerous pharmaceutical companies globally produce generic versions of atovaquone/proguanil. Examples include Teva Pharmaceuticals, Mylan (now Viatris), and various manufacturers in India and China.
• Distributors and Wholesalers: Companies that manage the logistics and distribution of pharmaceutical products to various markets.

Key Takeaways

• The manufacturing of atovaquone API is primarily undertaken by companies like IOL Chemicals and Pharmaceuticals Ltd. and Apeloa Pharmaceutical Co., Ltd., located in India and China, respectively.
• Proguanil hydrochloride API is predominantly supplied by Indian manufacturers, including Divi's Laboratories Limited and Granules India Limited.
• Finished Malarone dosage forms are likely produced by large, multinational contract manufacturing organizations (CMOs) with extensive experience in solid dosage forms and stringent GMP compliance, such as those within the Thermo Fisher Scientific (Patheon), Catalent Pharma Solutions, or Recipharm AB networks.
• The entire supply chain is subject to strict regulatory oversight, including GMP compliance, DMF/ASMF filings, site inspections, and pharmacopoeial standard adherence.
• The market is characterized by increasing generic competition, price sensitivity, and a significant role for public health programs in addition to traveler demand.

FAQs

1. What are the primary regulatory bodies overseeing Malarone production? The primary regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). National regulatory agencies in countries where Malarone is manufactured or sold also play a role.

2. Are there any specific certifications required for Malarone API suppliers? API suppliers must adhere to Good Manufacturing Practices (GMP) and typically require certifications such as US FDA approval, EDQM certification for Europe, and WHO GMP certification for global supply, especially for products used in public health programs.

3. How does patent expiration impact the suppliers of Malarone? Patent expiration leads to the entry of generic manufacturers. This increases demand for APIs from a broader base of suppliers and intensifies competition based on price and quality.

4. What are the typical quality control measures for Malarone APIs? Quality control for Malarone APIs includes testing for identity, purity, assay, residual solvents, heavy metals, and microbial limits, all according to pharmacopoeial standards (e.g., USP, Ph. Eur.) and internal company specifications.

5. Can a single CMO produce both Malarone APIs and the finished tablets? While some large pharmaceutical companies have integrated manufacturing capabilities, it is more common for specialized API manufacturers to produce the active ingredients, and separate contract manufacturing organizations (CMOs) to formulate and produce the finished dosage form (tablets) of Malarone.

Citations

[1] IOL Chemicals and Pharmaceuticals Ltd. (n.d.). Products. Retrieved from https://www.iolcp.com/products [2] Apeloa Pharmaceutical Co., Ltd. (n.d.). API Manufacturing. Retrieved from https://www.apeloa.com/en/about/apeloa-api/ [3] Divi's Laboratories Limited. (n.d.). Product List. Retrieved from https://www.divislabs.com/product-list/ [4] Granules India Limited. (n.d.). Product Portfolio. Retrieved from https://www.granulesindia.com/products.html [5] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practices (GMP). Retrieved from https://www.fda.gov/inspections-compliance-enforcement-and-self-assessments/good-manufacturing-practice-gmp [6] European Medicines Agency. (n.d.). Active Substance Master File (ASMF). Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/scientific-guideline-application-active-substance-master-file-asmf-procedure-rev2_en.pdf [7] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from https://www.usp.org/products/usp-nf [8] U.S. Food and Drug Administration. (n.d.). Drug Supply Chain Security Act (DSCSA). Retrieved from https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa [9] GlaxoSmithKline plc. (n.d.). Our Medicines. Retrieved from https://www.gsk.com/en-gb/products/our-medicines/