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.

08 Jan 2024
Admin
News Article

FDA Issues Warning Letter to Inopak Ltd. for Significant CGMP Violations in Drug Manufacturing Facility

Inopak Ltd.'s drug manufacturing facility in Ringwood, New Jersey, underwent an FDA inspection from July 24 to August 3, 2023, resulting in significant violations of CGMP regulations for finished pharmaceuticalsInopak Ltd.’s drug manufacturing facility in Ringwood, New Jersey, underwent an FDA inspection from July 24 to August 3, 2023, resulting in significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The inspection revealed non-conformance to CGMP in manufacturing, processing, and holding practices, rendering the drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Inopak’s response to the Form FDA 483 findings, submitted on August 24, 2023, was acknowledged, addressing violations observed during the inspection are-

Inopak Ltd. failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d))

The firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a))

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