Pharmaceutical Grade CBD for Research, Clinical Trials, and Contract Manufacturing
Vantage Hemp has now submitted two Drug Master Files to the FDA for its pharmaceutical grade CBD – one for Broad Spectrum CBD Distillate (DMF #036876) and one for pure CBD Isolate (DMF #037784) A DMF is a regulatory filing containing confidential details about Vantage Hemp’s manufacturing processes, ingredients sourcing, quality control procedures, and more. It is used to inform the regulator about Vantage Hemp’s ability to produce safe, consistent, and effective pharmaceutical products. Only a small handful of CBD companies are able to accomplish this regulatory filing.
``We built the facility to be compliant with not only the food regulations, but more importantly, we built the facility to be compliant with the Good Manufacturing Practices for active pharmaceutical ingredients.”
Deepank Utkhede, Chief Operating Officer at Vantage
Your guide to science-based solutions.
Vantage offers world-class capabilities in the production of CBD extracts and manufactured goods. Our facilities have achieved ICH Q7 and WHO Good Manufacturing Practices (GMP) certifications from SGS – a global leader in manufacturing standards. Vantage provides CBD contract manufacturing solutions through the supply of CBD API for clinical studies, finished product formulation, and commercial production for global markets.
Your ally in rigorous pharmaceutical compliance.
Vantage understands the pharmaceutical regulatory filing and new drug business model. At Vantage, we provide cGMP (WHO GMP, FDA 21 CFR 210/211, ICHQ7) compliant clinical trial dosage formats to support your pursuit of regulatory approvals through all phases of clinical study, registration batches, and regulatory submissions for market approval. Vantage will actively meet your manufacturing needs with regard to phased clinical studies and commercialization finish and fill.
Your API partner of choice.
Vantage believes that industry relationships are founded on trust, capability, transparency, and expertise. Our manufacturing partnerships are just as important as the products we produce. Leveraging our extraction methods, manufacturing processes, and human resources will give you extensive and dedicated access to a team of CBD industry experts, clinical trial solutions, and global regulatory and commercial insights.
Clinical Trial Package
Work with Vantage Hemp to support your investigational new drug, clinical trial, and commercialization needs. Our team of experts has deep experience in pharmaceutical API manufacturing, drug delivery, and commercialization. Our clinical trials package includes:
Project Initiation
- Team Formation
- Project Governance
- Workstreams: Regulatory and Commercial
- Kick-off Meeting
- Project Monitoring and Reporting
Manufacturing Development Plan
- Description and number of required batches (active and non-active)
- Pre-formulation and formulation development using client cGMP SOPs
- Development of novel cGMP SOPs as required by client or regulator
- Manufacture, release, and perform stability testing for one (1) cGMP placebo clinical batch
- Manufacture, release, and perform stability testing for one (1) cGMP active clinical batch
- Phased studies – clinical batch planning, manufacturing planning (includes active and placebo), and distribution (finish & fill) support
- Demand planning and scaling for full commercialization
Prototype/Fill/Test
- Formulation Development
- Product Development
- Evaluation Criteria Development
- Materials Sourcing
- Clinical Product and Finished Product Manufacturing
- Release and Testing of Pre-clinical and Clinical Supplies
Required Studies
- Submit all required DEA requests, drug substance quantities, laboratory activity reports
- Submit regulatory filings for FDA, NIH, other bodies
- Conduct solubility and stability evaluations of the required APIs
- Identify excipient classes and conduct as needed compatibility screening
- Perform drug solubility testing and analysis
- Ensure if possible sourced excipients are listed on regulatory authorities Inactive Ingredients Database (IID) or identified as “Generally Regarded as Safe” (GRAS)
Ad Hoc Regulatory Support
- Provide regulatory and cGMP compliance advice in relation to product development and the associated regulatory filing strategy as required.
In developing novel drugs for novel indications, pharmaceutical companies and drug developers must have faith that their API provider and contract manufacturer can stay with them for the long haul. Vantage invests in world-class pharmaceutical manufacturing capabilities with a long-term view toward the CBD market. View our case study Formulation Development and cGMP Clinical Batch Manufacturing to learn more.
Pharmaceutical-Grade CBD Products by Vantage Hemp FAQs
What is Pharmaceutical Grade CBD?
Pharmaceutical Grade CBD products are created and tested in a laboratory setting to meet the compliance standards of the pharmaceutical industry. These include WHO GMP, FDA 21 CFR 210/211, and ICH Q7. Additionally, Vantage Hemp’s submission of a Drug Master File (DMF) to the US FDA indicates that all of Vantage’s products are manufactured using high-quality ingredients and under strict guidelines for purity, safety, and efficacy.
What is ICH Q7 certification, and why is it important?
Anyone who manufactures, tests, or packs pharmaceuticals or active pharmaceutical ingredients (APIs) must follow strict quality standards set forth by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q7 lays out these quality standards for Good Manufacturing Practices in the pharmaceutical industry. To obtain ICH Q7 certification, a company must pass a rigorous audit of its facilities, equipment, personnel, and quality control procedures.
What is cGMP CBD?
Current Good Manufacturing Practices (cGMP) is a product safety protocol that companies must follow during the CBD manufacturing process. cGMP CBD products are formulated in a way that human error is eliminated and the ingredients used have been tested, examined, and properly processed to create a finished product. cGMP ensures current innovation processes and production methods follow established scientific standards for data capture, data analysis, record keeping, and product labeling – and are constantly updated to the highest global standards.
What is WHO GMP and FDA 21 CFR 210/211 and why do they matter?
WHO GMP (World Health Organization – Good Manufacturing Practices) and FDA 21 CFR 210/211 (Food and Drug Administration Code of Federal Regulations Title 21) are guidelines that provide a framework for manufacturing quality pharmaceutical products. WHO GMP covers all aspects of production from raw materials used across the supply chain to the packaging and labeling of finished products on pharmacy shelves. Most countries have adopted WHO GMP as the gold standard in pharmaceutical manufacturing with FDA CFR 210/211 and ICH Q7.