Celecoxib (169590-42-5) API Manufacturers & Suppliers in India

Celecoxib is a widely used pharmaceutical compound that belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs). Specifically, it is classified as a COX-2 inhibitor, which means it selectively inhibits the cyclooxygenase-2 enzyme (COX-2) that plays a key role in the inflammatory process. Celecoxib is primarily used in the management of conditions like osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea, making it a key drug in the treatment of pain and inflammation.

The active pharmaceutical ingredient (API) Celecoxib, with the chemical structure identified by CAS number 169590-42-5, is produced in India by several pharmaceutical manufacturers that adhere to international quality standards. India, with its well-established pharmaceutical manufacturing sector, has become a leader in the production and export of high-quality Celecoxib API, making it a critical supplier to pharmaceutical companies worldwide.

In this article, we will explore the details of Celecoxib API, its manufacturing process, and why India is a preferred destination for sourcing this highly potent and complex compound.

What is Celecoxib (169590-42-5)?

Chemical Structure and Properties

Celecoxib, with the molecular formula C17H14F3N3O2S, is a white to off-white crystalline powder. It is highly soluble in organic solvents such as ethanol, methanol, and acetone but only slightly soluble in water. The unique chemical structure of Celecoxib allows it to selectively inhibit the COX-2 enzyme, which is responsible for producing prostaglandins — chemicals that promote inflammation, pain, and fever. By blocking the COX-2 enzyme, Celecoxib helps reduce inflammation and pain without significantly affecting the COX-1 enzyme, which is responsible for protecting the stomach lining.

The CAS number for Celecoxib is 169590-42-5, which is widely used in the pharmaceutical industry to identify the specific compound. Celecoxib has been proven to be effective for a range of medical conditions, including:

• Osteoarthritis: A degenerative joint disease causing pain and stiffness.


• Rheumatoid Arthritis: An autoimmune disease that leads to joint inflammation.


• Acute Pain: Pain associated with various injuries or surgeries.


• Dysmenorrhea: Painful menstrual cramps.

Celecoxib's selective action on COX-2 results in a reduced risk of gastrointestinal side effects, a common problem associated with traditional NSAIDs that inhibit both COX-1 and COX-2 enzymes. As a result, Celecoxib has gained popularity among patients who require long-term anti-inflammatory treatment.

Pharmaceutical Formulations

Celecoxib is typically formulated in the form of oral capsules, and its dosage varies depending on the condition being treated. For example:

• Osteoarthritis: 200 mg once daily or 100 mg twice daily.


• Rheumatoid Arthritis: 100 to 200 mg twice daily.


• Acute Pain: 400 mg as a single dose, followed by 200 mg after 12 hours if needed.

These formulations are crucial for ensuring proper dosage, bioavailability, and therapeutic effectiveness. Celecoxib is often prescribed for long-term use to manage chronic conditions, requiring consistent quality in both the raw API and finished products.

Manufacturing of Celecoxib API in India

India has become a global hub for the production of high-quality pharmaceutical APIs, including Celecoxib. The manufacturing process for Celecoxib API is highly specialized and involves several critical steps, from synthesis to final quality testing, ensuring that the API is both potent and safe for use in pharmaceutical formulations.

Synthesis of Celecoxib

The production of Celecoxib begins with the synthesis of the base chemical, which involves advanced organic chemistry techniques. The synthetic route includes multiple steps to create the core structure of Celecoxib, with specific attention paid to the selective inhibition of COX-2. Some of the key steps in the synthesis process include:

1. Building the Core Structure: The core structure of Celecoxib is built through a series of chemical reactions involving aromatic ring formation, fluorination, and other organic chemistry reactions. This process involves high precision and control to ensure the correct molecular configuration of the compound.


2. Fluorination: Fluorine is incorporated into the chemical structure of Celecoxib, as it is a critical feature that helps improve the drug's potency and selectivity for COX-2 inhibition. Fluorination is a challenging and delicate process that requires expertise in handling reactive chemicals and maintaining reaction conditions.


3. Sulfonation: The addition of a sulfonyl group is another key step in synthesizing Celecoxib. The sulfonyl group contributes to the solubility and stability of the API, which are crucial for its effectiveness in pharmaceutical formulations.


4. Purification: After synthesizing Celecoxib, the product undergoes rigorous purification processes to remove impurities and by-products. These include solvent extraction, crystallization, and filtration to ensure that the API is pure and meets pharmacopoeial standards.


5. Hydration and Final Processing: Depending on the final formulation requirements, Celecoxib may undergo additional steps such as hydration, drying, and blending to achieve the desired specifications for use in tablets or capsules.

Quality Control and Testing

Quality control is a critical aspect of the manufacturing process for Celecoxib API. The API must meet stringent regulatory standards to ensure safety, efficacy, and consistency. Several tests are conducted throughout the manufacturing process, including:

• Identification: Confirming the chemical identity of Celecoxib through techniques such as spectroscopic analysis (e.g., NMR, IR).


• Purity Testing: Analyzing the API for impurities or residual solvents that may compromise the safety and efficacy of the drug.


• Assay: Measuring the potency of the API to ensure that it contains the required amount of active ingredient.


• Microbial Testing: Ensuring that the API is free from harmful microorganisms.


• Stability Testing: Evaluating the stability of the API under various storage conditions to ensure long-term shelf-life.

Regulatory bodies like the US FDA, EMA, and WHO impose strict guidelines on the manufacturing processes of APIs, and Indian manufacturers comply with these standards to produce Celecoxib API that meets global quality requirements.

Packaging and Distribution

Once the Celecoxib API passes all quality tests, it is packaged in appropriate containers that protect the product from moisture, light, and contamination. Packaging materials used may include plastic drums, glass containers, or vacuum-sealed bags. The packaging is designed to ensure the API remains stable until it reaches the pharmaceutical companies that will use it in final drug formulations.

Celecoxib API is then distributed to pharmaceutical manufacturers, who convert it into tablets, capsules, and other dosage forms for use by patients.

Why India is the Leading Destination for Celecoxib API Manufacturing

India has become a global leader in the production and export of Celecoxib API due to several reasons:

1. Cost-Effective Production

India offers a competitive advantage in terms of labor costs, raw materials, and operational expenses, allowing manufacturers to produce Celecoxib API at a lower cost compared to other countries. This cost-efficiency is particularly valuable to international pharmaceutical companies that seek affordable yet high-quality APIs.

2. Adherence to International Quality Standards

Indian manufacturers of Celecoxib API strictly adhere to global regulatory standards such as Good Manufacturing Practices (GMP), ISO certifications, and other pharmacopoeial requirements. This commitment to quality ensures that the APIs produced meet the safety and efficacy standards required by regulatory authorities such as the US FDA, EMA, and WHO.

3. Expertise in Complex API Synthesis

India's pharmaceutical industry is renowned for its expertise in the synthesis of complex and high-potency APIs like Celecoxib. The country's skilled workforce, advanced infrastructure, and knowledge in organic chemistry allow manufacturers to produce APIs with high precision and purity.

4. Strong Export Market

India is a significant exporter of Celecoxib API, catering to markets in North America, Europe, Asia, and Africa. The country’s well-established export channels and logistical infrastructure ensure that Celecoxib API reaches global customers on time and in optimal condition.

5. R&D and Innovation

Indian pharmaceutical companies invest heavily in research and development (R&D) to enhance the quality, potency, and efficiency of APIs like Celecoxib. These companies continually innovate to optimize production processes and improve the overall quality of the APIs.

Top Celecoxib API Manufacturers in India

Several leading pharmaceutical companies in India specialize in the production of Celecoxib API. These manufacturers have state-of-the-art facilities and follow rigorous quality control procedures to ensure the production of premium-quality Celecoxib API.

KekulePharma

KekulePharma is one of India’s leading manufacturers and suppliers of high-quality Celecoxib API. The company’s commitment to product excellence, regulatory compliance, and cost-effectiveness makes it a preferred supplier for pharmaceutical companies worldwide.

Aurobindo Pharma

Aurobindo Pharma is another prominent player in the API manufacturing sector in India. The company produces Celecoxib API in large quantities, ensuring that it meets global standards of quality and safety.

Hetero Drugs

Hetero Drugs is a well-established API manufacturer in India known for its expertise in the production of complex and potent APIs, including Celecoxib. The company has a strong presence in international markets, providing reliable and high-quality APIs to pharmaceutical companies across the world.

Celecoxib (CAS number 169590-42-5) is a crucial API used in the treatment of pain and inflammation associated with various medical conditions, including osteoarthritis, rheumatoid arthritis, and acute pain. India has established itself as a leading hub for the production and export of Celecoxib API due to its cost-effective manufacturing processes, skilled workforce, and adherence to international quality standards. Pharmaceutical companies in India, such as KekulePharma, Aurobindo Pharma, and Hetero Drugs, are at the forefront of Celecoxib API production, ensuring global availability of this vital compound.

As the global demand for Celecoxib continues to grow, India will remain a key player in the API manufacturing sector, providing high-quality products at competitive prices to pharmaceutical companies around the world. Whether you're a pharmaceutical company looking for a reliable supplier or seeking to learn more about the manufacturing process, India is the destination for sourcing high-quality Celecoxib API.