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Looking for 58-55-9 / Theophylline API manufacturers, exporters & distributors?

Theophylline manufacturers, exporters & distributors 1


PharmaCompass offers a list of Theophylline 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 Theophylline manufacturer or Theophylline supplier for your needs.

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

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

API | Excipient name



58-55-9, 1,3-dimethylxanthine, Elixophyllin, Theophyllin, Theophylline anhydrous, Theolair

Cas Number


Unique Ingredient Identifier (UNII)


About Theophylline

A methyl xanthine derivative from tea with diuretic, smooth muscle relaxant, bronchial dilation, cardiac and central nervous system stimulant activities. Theophylline inhibits the 3',5'-CYCLIC NUCLEOTIDE PHOSPHODIESTERASE that degrades CYCLIC AMP thus potentiates the actions of agents that act through ADENYLYL CYCLASES and cyclic AMP.

Theophylline Manufacturers

A Theophylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Theophylline, including repackagers and relabelers. The FDA regulates Theophylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Theophylline 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 Theophylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Theophylline Suppliers

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

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

Theophylline USDMF

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

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

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

Theophylline 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 Theophylline Drug Master File in Japan (Theophylline JDMF) empowers Theophylline 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 Theophylline JDMF during the approval evaluation for pharmaceutical products. At the time of Theophylline 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 Theophylline suppliers with JDMF on PharmaCompass.

Theophylline CEP

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

A Theophylline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Theophylline 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 Theophylline suppliers with CEP (COS) on PharmaCompass.

Theophylline WC

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

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

Theophylline 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 Theophylline as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Theophylline 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 Theophylline 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 Theophylline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Theophylline NDC to their finished compounded human drug products, they may choose to do so.

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

Theophylline GMP

Theophylline 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 Theophylline 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 Theophylline GMP manufacturer or Theophylline GMP API supplier for your needs.

Theophylline CoA

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

Theophylline CoA mostly includes findings from lab analyses of a specific batch. For each Theophylline 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.

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