1. What is the Chemxpert database?

Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

2. How can I subscribe to the Chemxpert database?

You can gain access to the Chemxpert database after subscribing to it by visiting this link: - https://chemxpert.com/pricing

3. How many countries' data is available on your portal?

The Chemxpert database covers more than 200 countries. We are working in the direction of expanding our data coverage in more countries.

4. What are the different sources you use for obtaining information?

The different sources we use for data collection are as follows: - • Primary researc • DMF, ANDA, & CEP list • Conferences, Exhibitions, & Tradeshow • Company annual reports • DMF, ANDA, & CEP list • Subject matter experts & KOL survey. Apart from these, our other valuable sources include application-wise manufacturers list, subscribed and non-subscribed databases, corporate partners, US FDA Orange book, publicly available sources, industry associates, national statistics, regulatory websites, etc. You can gain access to the Chemxpert database after subscribing to it by visiting this link: -https://chemxpert.com/sources

5. What is the expected time for account activation?

Your Chemxpert account will be activated instantly if the payment is made through our website. If you choose to use RTGS, NEFT, or IMPS systems for payment, your account will be activated within 24 hours.

Understanding Drug Master File (DMF) for Corticosteroids

Admin
Drug Master File (DMF)
16 May 2024

Introduction:

Drug Master Files or DMFs are confidential submissions from drug or excipient producers to the FDA.
Details on the facilities, processes or articles used for manufacturing, processing, packaging and storage of human medicinal products are included in these files.
DMFs are used as reference documents for regulatory authorities and do not disclose their contents to third parties.
In particular, DMFs are not approved or disapproved; instead, FDA reviews their technical content in connection with applications referring to them. (e.g., NDAs, ANDAs, INDs, BLAs).
This blog addresses the significance of DMF in corticosteroids, explaining its components, submission process and implications for pharmaceutical companies as well as regulators.

Corticosteroids Overview:

Corticosteroids, irrespective of their natural or synthetic origin, are potent anti-inflammatory and immunosuppressive agents. Given that they are commonly prescribed for a wide variety of illnesses, such as asthma, allergies and autoimmune diseases, their regulation requires particular attention to detail.

Importance of DMF for Corticosteroids:

By providing comprehensive information on corticosteroid products, DMF ensures regulatory compliance. It ensures confidentiality, streamlines the review process, guarantees quality assurance and facilitates access to global markets.

Components of DMF for Corticosteroids:

The DMF consists of essential sections on the product's introduction, drug substances, drugs products, production processes, excipient controls, analytical techniques, stability studies, container closure systems, reference standards and legal status.

Types of DMFs:

DMFs are classified into different types, such as type I, type II, type III and so on, each serving a particular purpose.
For example, Type II DMFs contain information related to drug substance, drug substance intermediates, and material used in their preparation.

Submission Process for DMF: https://chemxpert.com/

The DMF submission process requires a high degree of precision and compliance with regulatory standards from the preparation of the dossier to the submission, review and maintenance of the dossier.

Chemxpert Database

The complete information on corticosteroid DMFs can be found through Chemxpert database. This includes information about the mechanism of action, synthesis method, buyer, seller, industry use, market size, clinical trials, currently conducted research studies, regulations and pricing trends. Chemxpert database contains valuable insights on corticosteroids such as hydrocortisone, prednisone, triamcinolone, Methylprednisolone, etc.

Conclusion:

In conclusion, in order to guarantee excellence, safety and compliance with the rules on corticosteroids it is essential that a Drug Master File are made available. By providing complete documentation of manufacturing procedures, quality control protocols and analytical methods, it facilitates the approval of applications for marketing authorizations and contributes to a higher level of health protection. Regulatory authorities shall cooperate with manufacturers in order to examine DMF submissions and assess the quality and safety of products, so as to accelerate their entry into the market for corticosteroids. Finally, the DMF plays a key role in ensuring regulatory oversight, effectiveness and patient centered health care within the pharmaceutical industry.

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