KETOROLAC TROMETHAMINE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	214456	ANDA	A-S Medication Solutions	50090-6772-0	25 VIAL in 1 CARTON (50090-6772-0) / 2 mL in 1 VIAL	2022-11-02
Alembic	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	214456	ANDA	A-S Medication Solutions	50090-6772-1	1 VIAL in 1 CARTON (50090-6772-1) / 2 mL in 1 VIAL	2022-11-02
Alembic	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	214456	ANDA	A-S Medication Solutions	50090-6807-0	25 VIAL in 1 CARTON (50090-6807-0) / 1 mL in 1 VIAL	2022-11-02
Alembic	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	214456	ANDA	Alembic Pharmaceuticals Inc.	62332-599-25	25 VIAL in 1 CARTON (62332-599-25) / 1 mL in 1 VIAL (62332-599-01)	2022-11-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This analysis identifies key global suppliers of ketorolac tromethamine active pharmaceutical ingredient (API). It details product specifications, regulatory compliance, and current market dynamics impacting supply chains.

Who are the primary global manufacturers of ketorolac tromethamine API?

The global supply of ketorolac tromethamine API is concentrated among a select group of manufacturers, primarily located in India and China, with some presence in Europe. These companies operate under stringent quality control and regulatory frameworks to meet international pharmaceutical standards.

Major Manufacturers:
- India:
  - Divi's Laboratories: A significant producer of APIs, including NSAIDs. They operate multiple FDA-inspected facilities.
  - Dr. Reddy's Laboratories: A diversified pharmaceutical company with a strong API manufacturing arm.
  - Laurus Labs: Known for its robust manufacturing capabilities and diverse API portfolio.
  - Aarti Industries: A major chemical and pharmaceutical manufacturer with a focus on intermediates and APIs.
- China:
  - Nanjing Pharmaceutical Factory Co., Ltd.: A key player in the Chinese API market.
  - Zhejiang Jiuzhou Pharmaceutical Co., Ltd.: Engaged in the production of APIs and intermediates.
  - Hubei Biocause Pharmaceutical Co., Ltd.: A listed company with substantial API production capacity.
- Europe:
  - Roche Diagnostics (Switzerland): While primarily known for diagnostics, they have historically been involved in certain API manufacturing. (Note: Direct API supply of ketorolac tromethamine from Roche for generic markets is less prominent compared to Indian and Chinese manufacturers. This mention reflects historical broader involvement in pharmaceutical manufacturing and may require specific confirmation for current ketorolac tromethamine API sourcing.)

What are the typical product specifications and quality standards for ketorolac tromethamine API?

Ketorolac tromethamine API is manufactured to meet pharmacopeial standards established by major regulatory bodies. These specifications ensure the identity, purity, strength, and quality of the drug substance.

Key Pharmacopeial Standards:
- United States Pharmacopeia (USP)
- European Pharmacopoeia (EP)
- Japanese Pharmacopoeia (JP)
Typical Specifications:
- Appearance: White to off-white crystalline powder.
- Solubility: Freely soluble in water, sparingly soluble in methanol, practically insoluble in ether.
- Identification: Confirmed by Infrared (IR) spectroscopy and High-Performance Liquid Chromatography (HPLC) retention time.
- Assay: Typically not less than 98.0% and not more than 102.0% of ketorolac tromethamine, calculated on the dried basis.
- Related Substances/Impurities: Limits are set for specific known impurities (e.g., ketorolac impurity A, B, C, D) and total impurities, as determined by HPLC. These limits are usually in the range of NMT 0.1% for individual impurities and NMT 0.5% for total impurities.
- Water Content: Determined by Karl Fischer titration, typically NMT 1.0%.
- Residue on Ignition (Sulfated Ash): Usually NMT 0.1%.
- Heavy Metals: NMT 10 ppm.
- Residual Solvents: Conforms to ICH Q3C guidelines, with specific limits for solvents used in the manufacturing process (e.g., methanol, ethanol, isopropyl alcohol, ethyl acetate).
- Particle Size Distribution: Can be critical for formulation and dissolution rates, with specific requirements depending on the intended dosage form (e.g., oral tablets, injectable solutions).

Which regulatory bodies oversee the manufacturing and quality of ketorolac tromethamine API?

Manufacturers must comply with regulations set forth by national and international health authorities to ensure the safety and efficacy of their API.

Primary Regulatory Bodies:
- U.S. Food and Drug Administration (FDA): Inspects manufacturing facilities for compliance with Current Good Manufacturing Practices (cGMP) and reviews Drug Master Files (DMFs).
- European Medicines Agency (EMA): Oversees API quality through national competent authorities within EU member states and assesses Certificates of Suitability (CEPs).
- Pharmaceuticals and Medical Devices Agency (PMDA) of Japan: Regulates APIs for the Japanese market.
- Central Drugs Standard Control Organization (CDSCO) of India: Licenses API manufacturers within India.
- National Medical Products Administration (NMPA) of China: Regulates pharmaceutical products and manufacturing in China.

What are the common manufacturing routes and raw materials for ketorolac tromethamine?

The synthesis of ketorolac tromethamine involves several chemical steps, starting from readily available chemical precursors.

Key Intermediates and Starting Materials:
- Pyrrole-2-carboxylic acid derivatives: Often serve as a core building block.
- 2-Amino-4-chlorobenzoic acid: A common precursor for the benzoyl moiety.
- Tromethamine (Tris(hydroxymethyl)aminomethane): The counter-ion, crucial for salt formation.
- Various reagents and solvents: Including acylating agents, bases, acids, and organic solvents for reaction and purification.
Typical Synthesis Steps (Simplified):
1. Formation of the ketorolac acid precursor through acylation and cyclization reactions.
2. Purification of ketorolac acid.
3. Salt formation with tromethamine in a suitable solvent system.
4. Crystallization and drying of ketorolac tromethamine API.

The efficiency and cost-effectiveness of these routes are influenced by the availability and pricing of key raw materials.

What are the current market dynamics impacting the supply of ketorolac tromethamine?

The ketorolac tromethamine API market is influenced by several factors, including demand from generic drug manufacturers, regulatory changes, and supply chain vulnerabilities.

Demand Drivers:
- Generic Pharmaceutical Market: Ketorolac tromethamine is widely used in pain management, with numerous generic formulations available globally, driving consistent demand for API.
- Therapeutic Applications: Primarily used for short-term management of moderate to moderately severe pain, particularly post-operative pain.
Supply Chain Considerations:
- Geographic Concentration: Reliance on a few key manufacturing hubs (India, China) can create supply risks due to geopolitical events, natural disasters, or trade restrictions.
- Raw Material Availability: Fluctuations in the cost and availability of key starting materials and intermediates can impact production costs and lead times.
- Regulatory Scrutiny: Increased scrutiny by regulatory agencies on API quality and cGMP compliance can lead to production halts or recalls for non-compliant manufacturers, affecting overall supply.
- Quality Control: Stringent quality requirements necessitate robust quality assurance processes, which can add to production timelines and costs.
Competitive Landscape:
- Price Sensitivity: As a widely genericized drug, pricing is a significant competitive factor among API suppliers.
- Lead Times: Ability to provide consistent and timely delivery is crucial for pharmaceutical formulators.

What are the key considerations for pharmaceutical companies sourcing ketorolac tromethamine API?

Sourcing ketorolac tromethamine API requires a rigorous evaluation of suppliers to ensure quality, reliability, and regulatory compliance.

Supplier Qualification Process:
- Regulatory Compliance: Verification of FDA DMF availability, CEPs, or equivalent documentation for target markets. Audit history of manufacturing sites.
- Quality Management System (QMS): Assessment of the supplier's cGMP adherence, including robust change control, deviation management, and CAPA systems.
- Technical Capabilities: Evaluation of manufacturing processes, analytical testing capabilities, and impurity profiling.
- Supply Chain Security: Assessment of the supplier's raw material sourcing, inventory management, and business continuity plans.
- Financial Stability: Ensuring the long-term viability of the supplier.
Contractual Agreements:
- Clearly defined specifications, quality parameters, and release testing procedures.
- Provisions for audits, change notification, and supply disruptions.
- Intellectual property considerations and confidentiality.
Risk Mitigation:
- Diversifying supplier base where possible to reduce reliance on a single source.
- Maintaining buffer stock of critical raw materials and finished API.
- Establishing strong communication channels with suppliers.

What is the outlook for the ketorolac tromethamine API market?

The ketorolac tromethamine API market is expected to remain stable, driven by continued demand for pain management therapies.

Projected Trends:
- Continued Generic Dominance: The market will largely be served by generic manufacturers, maintaining competitive pricing.
- Increasing Regulatory Expectations: Sharpened focus on API quality and traceability by global regulatory bodies will favor suppliers with strong compliance records.
- Supply Chain Resilience: Greater emphasis on supply chain transparency and risk management may lead to strategic sourcing adjustments.
- Potential for Process Improvements: Ongoing research into more efficient or environmentally friendly synthesis routes could emerge, though significant shifts are unlikely given the mature nature of the product.

Key Takeaways

The global supply of ketorolac tromethamine API is dominated by manufacturers in India and China, with Divi's Laboratories, Dr. Reddy's Laboratories, Laurus Labs, Aarti Industries, Nanjing Pharmaceutical Factory, Zhejiang Jiuzhou Pharmaceutical, and Hubei Biocause Pharmaceutical being key players.
API quality adheres to strict pharmacopeial standards (USP, EP, JP) concerning purity, related substances, and residual solvents.
Regulatory oversight by the FDA, EMA, PMDA, CDSCO, and NMPA is critical for market access.
The market is characterized by price sensitivity, driven by the generic nature of ketorolac tromethamine formulations.
Supply chain resilience and consistent cGMP compliance are paramount for pharmaceutical companies sourcing this API.

Frequently Asked Questions

What is the typical lead time for bulk ketorolac tromethamine API from major suppliers? Lead times can vary significantly based on supplier inventory, production schedules, and order volume, but generally range from 4 to 12 weeks for established suppliers with regular production runs. Expedited orders may incur additional costs.
Are there any significant patent expiries or new patent filings relevant to ketorolac tromethamine API manufacturing processes? The primary patents for ketorolac tromethamine itself have long expired. While new patents might exist for specific polymorphs, novel formulations, or improved manufacturing processes, these generally do not block the supply of standard API to generic markets.
How does the cost of tromethamine impact the overall cost of ketorolac tromethamine API? Tromethamine is a crucial, albeit relatively simple, raw material. Its market price can influence the final API cost, but typically the complexity of the ketorolac acid synthesis and purification processes contribute more significantly to the overall manufacturing expense.
What are the primary risks associated with relying on a single supplier for ketorolac tromethamine API? Reliance on a single supplier exposes a company to risks including production disruptions (e.g., plant shutdowns, quality issues, natural disasters), price increases, and potential supply shortages that could halt drug manufacturing.
Does the use of ketorolac tromethamine in different dosage forms (e.g., injectable vs. oral) necessitate different API specifications? While the core chemical identity and purity standards remain consistent, API specifications may differ slightly based on the intended dosage form. For instance, particle size distribution, polymorphic form, and bulk density can be tailored to optimize dissolution and bioavailability for oral formulations or to ensure solubility and stability for injectable solutions.

Citations

[1] United States Pharmacopeia. (n.d.). Ketorolac Tromethamine. Retrieved from USP-NF Online. [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Ketorolac Tromethamine. Retrieved from EDQM Website. [3] Divi's Laboratories. (n.d.). API Portfolio. Retrieved from Divi's Laboratories Official Website. [4] Dr. Reddy's Laboratories. (n.d.). APIs. Retrieved from Dr. Reddy's Laboratories Official Website. [5] Laurus Labs. (n.d.). APIs. Retrieved from Laurus Labs Official Website. [6] Aarti Industries. (n.d.). Pharmaceuticals. Retrieved from Aarti Industries Official Website. [7] Nanjing Pharmaceutical Factory Co., Ltd. (n.d.). Products. Retrieved from Nanjing Pharmaceutical Factory Official Website. [8] Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from Zhejiang Jiuzhou Pharmaceutical Official Website. [9] Hubei Biocause Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from Hubei Biocause Pharmaceutical Official Website. [10] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1997). Impurities: Guideline for Residual Solvents Q3C(R6). ICH. [11] U.S. Food and Drug Administration. (n.d.). Inspections, Compliance, Enforcement, and Criminal Investigations. Retrieved from FDA Website. [12] European Medicines Agency. (n.d.). Active substances. Retrieved from EMA Website.

Suppliers and packagers for KETOROLAC TROMETHAMINE