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.

10 Apr 2024
Admin
News Article

Boehringer Ingelheim Gains Approval for Supply of EU and US Markets

Boehringer Ingelheim Biopharmaceuticals China receives approval for supply of EU and US markets

Overview

Boehringer Ingelheim Biopharmaceuticals China (BioChina), in collaboration with a customer, has successfully passed pre-approval inspections by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

Approval for Transforming Lives

As a result, the customer is now approved for the supply of the biopharmaceutical to the EU and US markets from product manufactured by Boehringer Ingelheim Biopharmaceuticals China.
The inspections validated compliance with ICH, GxP regulations, international manufacturing standards, and patient safety requirements at Boehringer Ingelheim’s OASIS manufacturing site in Shanghai.
As part of the Boehringer Ingelheim Biopharmaceutical’s global manufacturing network, BioChina continues to uphold the corporate values and commitment to providing safe, effective, and high-quality medications.
“For us as a world-leading contract manufacturer of biopharmaceuticals, the official approvals for our site are a confirmation of our own aspiration to transform lives for generations,” explains Ulrike Falk, head of global quality biopharma operations at Boehringer Ingelheim.

Boehringer Ingelheim’s contract manufacturing activities in China, began in 2013, as a pioneer under a new regulatory framework of the CMO/MAH trial project by the local authority, National Medical Products Administration (NMPA).

First Authorization Holder

Through its collaboration and the provision of manufacturing services for this biopharmaceutical, Boehringer Ingelheim Biopharmaceuticals China was the first company to successfully apply the adopted Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law (DAL).
As a result, this customer product is the first innovative biologic commissioned under the new MAH model in China.

Words from Boehringer Ingelheim

“With recent approvals of this biologic by renowned health authorities including EMA, MFDS, and now the FDA, BioChina continues on a transformative journey supplying our long-time partner in expanding global reach. By offering our partner top-tier quality products, BioChina is fully devoted to improving the lives of patients worldwide,” states Dr. Yuguo Zang, head of BioChina at Boehringer Ingelheim.

This important milestone underscores Boehringer Ingelheim's capabilities in high quality manufacturing services to support local partners with global patient supplies.

On Breakthrough Therapies

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come.
As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need.

Boehringer Ingelheim BioXcellence

Boehringer Ingelheim BioXcellence creates solutions with its customers to reliably supply innovative therapies.
One of the world’s largest manufacturers of biopharmaceuticals and an industry pioneer with in-depth experience, Boehringer Ingelheim BioXcellence so far has supplied more than 40 commercial products through its global network.

Let’s apply Data-Driven Pricing to Your APIs

Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.

Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.

Start using market intelligence today and allow yourself to be in control in the API market.

Check it out today and make more informed sourcing decisions! Learn More!