DMF Filings & Regulatory Approvals
Where our dossiers are filed, and what we can support in your submission.
A supplier's filing position determines which markets you can take their material into, so it is worth being precise about it rather than implying broader coverage than exists.
The register below lists where we hold dossiers today. Filing numbers and letters of access are issued to customers under agreement.
Filing register
| Product | Authority | Type | Status |
|---|---|---|---|
| Paracetamol | US FDA | Type II DMF | Active |
| Paracetamol | EDQM | CEP | Granted |
| Metformin Hydrochloride | US FDA | Type II DMF | Active |
| Metformin Hydrochloride | CDSCO, India | Written Confirmation | Held |
| Ibuprofen | EDQM | CEP | Under assessment |
| Atorvastatin Calcium | US FDA | Type II DMF | Active |
Regulatory support we provide to customers
Letters of access
Issued for our filed dossiers so your submission can reference them, with the filing number and date stated.
Deficiency responses
We answer agency questions on our sections of your dossier directly, rather than sending you a summary to translate.
Open part documentation
Open part of the DMF supplied to customers under agreement, covering specification, methods, stability and impurity profile.
Questionnaires and audits
Supplier qualification questionnaires completed and on-site or remote audits accommodated as part of your vendor qualification.
Change notification
Advance written notice of any change that could affect your filing, with the regulatory impact assessment attached.
Market-specific certificates
Certificates of origin, GMP certificates, free sale certificates and other market-specific documents prepared per consignment.
Speak to someone who knows the answer
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