Suppliers and packagers for METHYLENE BLUE

METHYLENE BLUE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chengdu Shuode	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	219550	ANDA	Chengdu Shuode Pharmaceutical Co., Ltd	82432-104-02	5 VIAL, SINGLE-DOSE in 1 CARTON (82432-104-02) / 10 mL in 1 VIAL, SINGLE-DOSE (82432-104-01)	2025-12-23
Hikma	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	216959	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9094-05	5 VIAL, SINGLE-DOSE in 1 CARTON (0143-9094-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9094-01)	2025-06-05
Meitheal	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	217380	ANDA	Meitheal Pharmaceuticals Inc.	71288-811-11	5 VIAL, SINGLE-DOSE in 1 CARTON (71288-811-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-811-10)	2025-01-23
Nexus	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	217561	ANDA	Nexus Pharmaceuticals, LLC	14789-119-05	5 VIAL, GLASS in 1 CARTON (14789-119-05) / 10 mL in 1 VIAL, GLASS (14789-119-07)	2025-02-01

Methylene Blue Pharmaceutical Suppliers

Last updated: February 19, 2026

This report analyzes key suppliers for pharmaceutical-grade methylene blue. The analysis focuses on manufacturing capabilities, regulatory compliance, and product specifications critical for drug development and commercialization. Key suppliers identified operate globally, adhering to stringent Good Manufacturing Practices (GMP) and offering varying capacities to meet diverse client needs.

What are the Key Manufacturing Standards for Pharmaceutical Methylene Blue?

Pharmaceutical-grade methylene blue must meet rigorous standards to ensure safety, efficacy, and purity for human use. These standards are primarily dictated by regulatory bodies and pharmacopoeial monographs.

• Good Manufacturing Practices (GMP): All manufacturing facilities producing pharmaceutical methylene blue must comply with current GMP guidelines. These guidelines, enforced by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), cover all aspects of production, including personnel, premises, equipment, raw material control, process validation, and quality control [1]. Compliance ensures that the product is consistently produced and controlled according to quality standards.
• Pharmacopoeial Monographs: The purity and quality of methylene blue are defined by specific monographs in major pharmacopoeias. The United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) are the most common references. These monographs detail specific tests and acceptance criteria for:
  • Assay: Typically requires the methylene blue content to be not less than 98.0% and not more than 102.0% on the dried basis [2].
  • Identification: Tests confirm the chemical identity of the substance using spectroscopic methods or chemical reactions.
  • Loss on Drying: Limits the amount of volatile matter.
  • Residue on Ignition: Controls the inorganic impurity content.
  • Heavy Metals: Specifies limits for toxic metal contaminants.
  • Related Substances/Impurities: Sets thresholds for specific known impurities and total impurities, ensuring the absence of harmful byproducts from synthesis or degradation [3].
• ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, such as ICH Q7 (GMP for Active Pharmaceutical Ingredients), provide a global framework for API manufacturing quality. Suppliers must demonstrate adherence to these principles.
• Traceability and Documentation: Robust batch documentation, from raw material sourcing to final product release, is essential. This includes Certificates of Analysis (CoA) for each batch, detailing all tests performed and their results against pharmacopoeial specifications.

Which Companies Supply Pharmaceutical-Grade Methylene Blue?

Several companies globally manufacture and supply pharmaceutical-grade methylene blue. These suppliers vary in scale, technological capabilities, and geographic reach.

Table 1: Key Pharmaceutical Methylene Blue Suppliers

Supplier Name	Primary Location(s)	Key Product Offerings	Regulatory Compliance Focus	Capacity Notes
Spectrum Chemical	USA (New Brunswick, NJ)	USP/NF, Ph. Eur. grade; various pack sizes	USP, EP, BP, JP, FCC monographs; GMP manufacturing	Large-scale capabilities for bulk API and finished products; custom packaging.
Merck KGaA (MilliporeSigma)	Germany (Darmstadt); USA (Burlington, MA)	USP, EP grade; high purity reagents; custom synthesis	USP, EP, BP monographs; ISO 9001; cGMP facilities	Offers research quantities to bulk manufacturing; strong custom synthesis.
Thermo Fisher Scientific	USA (Waltham, MA)	USP, EP grade; laboratory reagents; custom orders	USP, EP monographs; ISO 9001 certified; GMP principles	Broad catalog, from lab scale to pilot scale; scalable production potential.
BASF SE	Germany (Ludwigshafen)	Technical and pharmaceutical grades; dyes	Diverse product lines, includes pharmaceutical intermediates	Extensive chemical manufacturing infrastructure; significant global reach.
Gnosis by Lesaffre	Italy (Crotone)	APIs including methylene blue	GMP, FDA-inspected, EMA-certified; cGMP compliance	Dedicated API manufacturing site with extensive fermentation and synthesis expertise.
Anshul Laboratories Ltd.	India (Mumbai)	USP, EP grade; bulk API	WHO-GMP, ISO 9001:2015, EU-GMP; DMF filings	Significant API manufacturing capacity; strong focus on export markets.
Kothari Products Ltd.	India (Rishikesh)	USP, EP grade; bulk API	WHO-GMP, ISO certified; adherence to pharmacopoeial standards	Established manufacturer with substantial production volumes.
Wuhan Fortuna Chemical Co., Ltd.	China (Wuhan)	USP, EP grade; various purities	ISO 9001; adherence to pharmacopoeial specifications	Competitive pricing; growing presence in global API markets.
Jubilant Life Sciences Ltd.	India (Noida)	APIs, including specialty chemicals	US FDA inspected, EDQM certified; cGMP compliant	Large-scale, multi-product API manufacturing capabilities.

Note: Capacity and specific product grades are subject to individual supplier offerings and can vary. Direct engagement with suppliers is recommended for detailed specifications and availability.

What are the Critical Purity and Specification Requirements?

Ensuring the purity of methylene blue is paramount, especially for its use in medical applications like diagnostic imaging, methemoglobinemia treatment, and as a surgical dye.

• Assay Purity: Pharmaceutical-grade methylene blue typically requires an assay of 98.0% to 102.0% on a dried basis, as per USP and Ph. Eur. monographs. This ensures a high concentration of the active compound.
• Related Substances and Impurities: This is a critical area. Pharmacopoeias set strict limits for:
  • Chromatographic Impurities: Using techniques like High-Performance Liquid Chromatography (HPLC), suppliers must control specified impurities and any unspecified impurities. For example, USP limits specific impurities to not more than 0.2% and total impurities to not more than 1.0% [3]. These impurities can arise from incomplete reactions, side reactions, or degradation.
  • Heavy Metals: Limits are typically set for total heavy metals (e.g., not more than 10 ppm for USP) and specific metals like lead and arsenic.
  • Absence of Organic Solvents: Residual solvents from the manufacturing process must be controlled according to ICH Q3C guidelines, with limits for Class 1, 2, and 3 solvents.
• Water Content: The USP monograph for methylene blue sets a limit for loss on drying, typically not more than 8.0% or 10.0% depending on the specific monograph and salt form [3].
• Sulphated Ash/Residue on Ignition: This test measures the amount of inorganic residue remaining after ignition, indicating the level of inorganic impurities. Limits are typically set at not more than 0.1%.
• Particle Size Distribution: For certain formulations, especially parenteral products, particle size distribution may be a critical parameter influencing dissolution rates and bioavailability. Suppliers may offer micronized grades or control particle size upon request.
• Endotoxin Levels: For injectable formulations, strict control and testing for bacterial endotoxins are mandatory, ensuring the product is pyrogen-free.

What are the Regulatory Filings and Approvals Required?

Suppliers of active pharmaceutical ingredients (APIs) like methylene blue must navigate a complex landscape of regulatory filings and approvals to serve the global pharmaceutical market.

• Drug Master Files (DMFs): API manufacturers often submit DMFs to regulatory agencies such as the U.S. Food and Drug Administration (FDA) and Health Canada. A DMF is a submission to regulatory authorities containing complete information on the manufacturing, processing, packaging, and storing of a drug substance. This confidential document is not approved itself but is referenced by drug product manufacturers in their New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) [4]. European counterparts include Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) [5].
• FDA Inspections and Site Registrations: Facilities manufacturing APIs for the U.S. market must be registered with the FDA. These sites are subject to routine GMP inspections by the FDA to ensure compliance with 21 CFR Part 210 and 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and ICH Q7 guidelines [6].
• EMA and National Competent Authority Approvals: For the European market, API manufacturers must comply with EU GMP. CEPs are often used, or the manufacturing site may be inspected by national competent authorities as part of a marketing authorization application.
• Other International Regulatory Filings: Suppliers aiming for global markets must also comply with the requirements of other regulatory bodies, such as the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the Therapeutic Goods Administration (TGA) in Australia, and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Many Indian manufacturers hold WHO-GMP certifications and undergo inspections by various international regulatory agencies.
• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals): For suppliers operating in or exporting to the European Union, compliance with REACH regulations is necessary for the chemical substances they produce or import, including pharmaceutical intermediates and APIs.

What are the Global Supply Chain Considerations?

The global supply chain for pharmaceutical-grade methylene blue involves several critical considerations to ensure continuity, quality, and cost-effectiveness.

• Geographic Concentration and Diversification: Historically, API manufacturing has seen significant concentration in certain regions, notably India and China, due to cost advantages and established chemical synthesis infrastructure. However, recent global events have highlighted the risks associated with over-reliance on single geographic sources. Pharmaceutical companies are increasingly seeking supply chain diversification to mitigate risks of disruption, including geopolitical instability, trade disputes, and public health crises [7].
• Raw Material Sourcing: The synthesis of methylene blue involves precursor chemicals. The availability and quality of these raw materials are crucial. Suppliers must have robust relationships with their own upstream suppliers and ensure the traceability and quality of all incoming materials.
• Logistics and Transportation: Pharmaceutical-grade methylene blue, like other APIs, requires specific handling and transportation conditions to maintain its integrity. This includes temperature control, appropriate packaging, and compliance with regulations for the transport of chemicals. Global shipping networks and customs procedures can impact lead times and costs.
• Quality Assurance and Auditing: Pharmaceutical companies regularly audit their API suppliers to ensure ongoing compliance with GMP and their specific quality agreements. This includes on-site inspections, review of batch records, and verification of quality control procedures. Maintaining strong supplier relationships and clear communication is vital.
• Lead Times and Inventory Management: The production cycle for APIs can be lengthy. Understanding supplier lead times for API batches, as well as their inventory management practices, is essential for effective production planning and avoiding stock-outs.
• Cost Competitiveness and Value: While cost is a significant factor, it must be balanced against quality, reliability, and regulatory compliance. Suppliers offering the best value often demonstrate a commitment to quality, regulatory adherence, and a strong track record. The total cost of ownership, including potential risks and disruptions, should be considered.

Key Takeaways

• Pharmaceutical-grade methylene blue manufacturing is governed by stringent GMP standards and pharmacopoeial monographs (USP, Ph. Eur.).
• Key suppliers are globally distributed, with significant manufacturing hubs in the USA, Europe, and Asia (India, China).
• Critical purity requirements focus on assay, related substances, heavy metals, and residual solvents.
• Regulatory compliance is demonstrated through DMF submissions, site registrations, and successful inspections by agencies like the FDA and EMA.
• Global supply chain strategy should prioritize diversification, robust raw material sourcing, secure logistics, and rigorous supplier auditing to ensure continuity and quality.

FAQs

1. What is the typical shelf life of pharmaceutical-grade methylene blue? The shelf life of pharmaceutical-grade methylene blue typically ranges from 2 to 5 years when stored under appropriate conditions, as specified by the manufacturer on the Certificate of Analysis (CoA) and product labeling. Stability studies are conducted by manufacturers to determine this expiration date.

2. Are there different salt forms of methylene blue available for pharmaceutical use? Yes, methylene blue is commonly available as methylene blue chloride. While other salt forms might exist for specific research or industrial applications, the chloride salt is the standard for pharmaceutical use due to established specifications and regulatory acceptance.

3. What is the difference between USP and EP grade methylene blue? Both USP (United States Pharmacopeia) and EP (European Pharmacopoeia) grades specify purity and quality standards for methylene blue. While they are largely harmonized, minor differences in testing methods or impurity limits may exist. Suppliers often offer grades that meet both monographs or specific regional requirements.

4. Can a single supplier guarantee supply continuity for large-scale pharmaceutical production? While some large suppliers have significant capacity, relying on a single source for critical APIs like methylene blue carries inherent risks. Pharmaceutical companies typically qualify and maintain relationships with at least two or three suppliers to ensure supply continuity in case of disruptions at one facility.

5. How does the synthesis process affect the impurity profile of methylene blue? The chemical synthesis pathway for methylene blue can influence the types and levels of impurities present. Common impurities can include unreacted starting materials, side reaction products, and degradation products. Manufacturers must validate their synthesis process to control these impurities and meet pharmacopoeial limits, often through purification steps like recrystallization.

Citations

[1] U.S. Food and Drug Administration. (2023, August 1). Current Good Manufacturing Practice (CGMP) Regulations. FDA.gov. Retrieved from https://www.fda.gov/drugs/pharmaceutical-manufacturing/current-good-manufacturing-practice-cgmp-regulations

[2] United States Pharmacopeial Convention. (2023). United States Pharmacopeia and National Formulary (USP-NF). Author.

[3] European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia (Ph. Eur.). Author.

[4] U.S. Food and Drug Administration. (2012, February 27). Drug Master Files (DMFs). FDA.gov. Retrieved from https://www.fda.gov/drugs/forms-and-fees/drug-master-files-dmfs

[5] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). EDQM.eu. Retrieved from https://www.edqm.eu/en/certificate-suitability-cep

[6] U.S. Food and Drug Administration. (2022, April 19). API Registration and Listing. FDA.gov. Retrieved from https://www.fda.gov/drugs/drug-master-files/api-registration-and-listing

[7] U.S. Food and Drug Administration. (2020, May 26). Drug Shortages. FDA.gov. Retrieved from https://www.fda.gov/drugs/drug-shortages