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Looking for 169590-42-5 / Celecoxib API manufacturers, exporters & distributors?

Celecoxib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Celecoxib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Celecoxib manufacturer or Celecoxib supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Celecoxib manufacturer or Celecoxib supplier.

PharmaCompass also assists you with knowing the Celecoxib API Price utilized in the formulation of products. Celecoxib API Price is not always fixed or binding as the Celecoxib Price is obtained through a variety of data sources. The Celecoxib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Celecoxib

Synonyms

169590-42-5, Celebrex, Celebra, Onsenal, Celocoxib, Celecox

Cas Number

169590-42-5

Unique Ingredient Identifier (UNII)

JCX84Q7J1L

About Celecoxib

A pyrazole derivative and selective CYCLOOXYGENASE 2 INHIBITOR that is used to treat symptoms associated with RHEUMATOID ARTHRITIS; OSTEOARTHRITIS and JUVENILE ARTHRITIS, as well as the management of ACUTE PAIN.

Celecoxib Manufacturers

A Celecoxib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Celecoxib, including repackagers and relabelers. The FDA regulates Celecoxib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Celecoxib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Celecoxib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Celecoxib Suppliers

A Celecoxib supplier is an individual or a company that provides Celecoxib active pharmaceutical ingredient (API) or Celecoxib finished formulations upon request. The Celecoxib suppliers may include Celecoxib API manufacturers, exporters, distributors and traders.

click here to find a list of Celecoxib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Celecoxib USDMF

A Celecoxib DMF (Drug Master File) is a document detailing the whole manufacturing process of Celecoxib active pharmaceutical ingredient (API) in detail. Different forms of Celecoxib DMFs exist exist since differing nations have different regulations, such as Celecoxib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Celecoxib DMF submitted to regulatory agencies in the US is known as a USDMF. Celecoxib USDMF includes data on Celecoxib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Celecoxib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Celecoxib suppliers with USDMF on PharmaCompass.

Celecoxib JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Celecoxib Drug Master File in Japan (Celecoxib JDMF) empowers Celecoxib API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Celecoxib JDMF during the approval evaluation for pharmaceutical products. At the time of Celecoxib JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Celecoxib suppliers with JDMF on PharmaCompass.

Celecoxib KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Celecoxib Drug Master File in Korea (Celecoxib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Celecoxib. The MFDS reviews the Celecoxib KDMF as part of the drug registration process and uses the information provided in the Celecoxib KDMF to evaluate the safety and efficacy of the drug.

After submitting a Celecoxib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Celecoxib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Celecoxib suppliers with KDMF on PharmaCompass.

Celecoxib CEP

A Celecoxib CEP of the European Pharmacopoeia monograph is often referred to as a Celecoxib Certificate of Suitability (COS). The purpose of a Celecoxib CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Celecoxib EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Celecoxib to their clients by showing that a Celecoxib CEP has been issued for it. The manufacturer submits a Celecoxib CEP (COS) as part of the market authorization procedure, and it takes on the role of a Celecoxib CEP holder for the record. Additionally, the data presented in the Celecoxib CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Celecoxib DMF.

A Celecoxib CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Celecoxib CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Celecoxib suppliers with CEP (COS) on PharmaCompass.

Celecoxib WC

A Celecoxib written confirmation (Celecoxib WC) is an official document issued by a regulatory agency to a Celecoxib manufacturer, verifying that the manufacturing facility of a Celecoxib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Celecoxib APIs or Celecoxib finished pharmaceutical products to another nation, regulatory agencies frequently require a Celecoxib WC (written confirmation) as part of the regulatory process.

click here to find a list of Celecoxib suppliers with Written Confirmation (WC) on PharmaCompass.

Celecoxib NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Celecoxib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Celecoxib API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Celecoxib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Celecoxib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Celecoxib NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Celecoxib suppliers with NDC on PharmaCompass.

Celecoxib GMP

Celecoxib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Celecoxib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Celecoxib GMP manufacturer or Celecoxib GMP API supplier for your needs.

Celecoxib CoA

A Celecoxib CoA (Certificate of Analysis) is a formal document that attests to Celecoxib's compliance with Celecoxib specifications and serves as a tool for batch-level quality control.

Celecoxib CoA mostly includes findings from lab analyses of a specific batch. For each Celecoxib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Celecoxib may be tested according to a variety of international standards, such as European Pharmacopoeia (Celecoxib EP), Celecoxib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Celecoxib USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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