Drug Listing Clause Samples
Drug Listing. It shall be the responsibility of Reliant Regulatory to submit FDA Form #2657 every June and December updating the Drug Product Listing. When no changes have occurred since the previously submitted list, no report is required.
Drug Listing. The PRODUCTS are intended to be registered as a component of a medical device. In the event that the PRODUCTS are registered as a drug, TransMedics is responsible for drug listing domestic products as the REGULATORY APPROVAL holder, and distributor of the PRODUCTS. Fresenius will provide TransMedics with all reasonably required information related to Fresenius’s facility and operations needed to register the PRODUCTS.
Drug Listing. 14 APPENDIX I - The PRODUCTS........................... 15 APPENDIX II - List of Quality Contracts.............. 16 APPENDIX III - Release Documentation.................. 17 -34-
Drug Listing. 12.2.1 C*P is responsible for drug listing as the manufacturer of the PRODUCTS, while ORPHAN is responsible for drug listing as the distributor of the PRODUCTS. ORPHAN will provide C*P with all required information needed by them for their listing. ORPHAN will notify C*P of the scheduled PRODUCTS launch date.
Drug Listing. 12.2.1 C*P is responsible for drug listing as the manufacturer of the PRODUCTS, while POZEN is responsible for drug listing as the distributor of the PRODUCTS. POZEN will provide C*P with all required information needed by them for their listing. POZEN will notify C*P of the scheduled PRODUCTS launch date.
APPENDIX I The PRODUCTS MT 100 Tablets APPENDIX II List of Quality Contacts (name, phone, fax, e-mail) -------------------------------------------- ----------------------------------------- -------------------------------------------- ISSUE POZEN C*P -------------------------------------------- ----------------------------------------- -------------------------------------------- Product Release Donna Gilbert Jason Williams Ph: (919) ▇▇▇-▇▇▇▇ Ph: (252) 707-2182 Fax: (919) ▇▇▇-▇▇▇▇ Fax: (252) 707-7306 Dgilbert@▇▇▇▇▇.▇▇▇ jwilliams@catalytica-pharm.▇▇▇ -------------------------------------------- ----------------------------------------- -------------------------------------------- QC Testing Donna Gilbert Kirit Amin Ph: (919) 490-▇▇▇▇ Ph: (252) 707-2372 Fax: (919) ▇▇▇-▇▇▇▇ Fax: (252) 707-7027 Dgilbert@▇▇▇▇▇.▇▇▇ kamin@catalytica-pharm.com -------------------------------------------- ----------------------------------------- -------------------------------------------- Investigations Donna Gilbert Kathleen Bussell Ph: (91▇) ▇▇▇-▇▇▇▇ Ph: (252) 707-2128 Fax: (919) ▇▇▇-▇▇▇▇ Fax: (252) 707-2207 Dgilbert@▇▇▇▇▇.▇▇▇ kbussell@catalytica-pharm.c▇▇ -------------------------------------------- ----------------------------------------- -------------------------------------------- Stability Donna Gilbert Kirit Amin Ph: (919) 490-▇▇▇▇ Ph: (252) 707-2372 Fax: (919) ▇▇▇-▇▇▇▇ Fax: (252) 707-7027 Dgilbert@▇▇▇▇▇.▇▇▇ kamin@catalytica-pharm.com -------------------------------------------- ----------------------------------------- -------------------------------------------- Regulatory Affairs Donna Gilbert Beverly Lewis Ph: (919) ▇▇▇-▇▇▇▇ Ph: (252) 707-7913 Fax: (919) ▇▇▇-▇▇▇▇ Fax: (252) 707-2326 Dgilbert@▇▇▇▇▇.▇▇▇ Blewis@catalytica-pharm.com -------------------------------------------- ----------------------------------------- -------------------------------------------- Validation Donna Gilbert Frank Anasti Ph: (919) 4▇▇-▇▇▇▇ Ph: (252) 707-2651 Fax: (919) ▇▇▇-▇▇▇▇ Fax: (252) 707-7678 Dgilbert@▇▇▇▇▇.▇▇▇ Fanasti@catalytica-pharm.co▇ -------------------------------------------- ----------------------------------------- -------------------------------------------- Compliance Audit...
Drug Listing. 12.2.1 LONZA is responsible for drug listing as the manufacturer of the PRODUCT for ORPHAN, while ORPHAN is responsible for drug listing as the distributor of the PRODUCT. ORPHAN will provide LONZA with all required information needed to register the PRODUCT. ORPHAN will notify LONZA of the scheduled PRODUCT launch. {Appendices are attached} Bulk Drug Substance: Sodium Oxybate Powder Retest Date*: 56 months Storage Conditions: 15-30°C in packaging specified as follows Closure: Electrogalvanized Steel Lock Ring Cover: 24 Gauge Varnish/Precoated Chime Bands: Electrogalvanized Steel Top and Bottom Gasket: Urethane Supplier: Grief Brothers or Berenfield Containers Container: Polyethylene Bag Semi-Transparent Plastic Film EF603GU LDPE (95%), 100323 Anti-Stat (5%)
Drug Listing. C*P is responsible for drug listing as the manufacturer of the PRODUCTS, while CLIENT is responsible for drug listing as the distributor of the PRODUCTS. CLIENT will provide C*P with all required information needed by them for their listing. CLIENT will notify C*P of the scheduled product launch.
Drug Listing. 12.2.1 LONZA is responsible for drug listing as the manufacturer of the PRODUCT for ORPHAN, while ORPHAN is responsible for drug listing as the distributor of the PRODUCT. ORPHAN will provide LONZA with all required information needed to register the PRODUCT. ORPHAN will notify LONZA of the scheduled PRODUCT launch. {Appendices are attached} [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Some specification requirements for release of the bulk drug substance will be more restrictive than those approved in the NDA to ensure drug adequacy upon analytical retesting or anticipated degradation over time. Sodium Oxybate Powder must meet BP/EP/EC/Japan standards. Orphan Medical Quality Assurance will issue a certificate of analysis as the final release for the bulk drug substance. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Product Release [ * ] [ * ] QC Testing [ * ] [ * ] Investigations [ * ] [ * ] Regulatory Affairs [ * ] [ * ] Validation [ * ] [ * ] Compliance Audits [ * ] [ * ] Product Complaints [ * ] [ * ] Change Management [ * ] [ * ] Note: *[ * ], as the Product Manager for SXB is the backup for all contacts. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Drug Listing. SkyePharma is responsible for drug listing domestic products as the manufacturer of the PRODUCTS, while Enzon is responsible for drug listing as the distributor of the PRODUCTS. Enzon and SkyePharma will provide each other with all required information needed to register the PRODUCTS.
Drug Listing. DSM is responsible for drug listing as the manufacturer of the Products for Barrier, while Barrier is responsible for drug listing as the distributor of the Products. Barrier will provide DSM with all required information needed to register the Products. Barrier will notify DSM of the scheduled Product launch, where applicable. [Appendices are attached] • Zimycan ointment ▇▇▇, ▇▇▇▇, & 60gm Product Release *** *** QC Testing *** *** Investigations *** *** Regulatory Affairs *** *** Validation *** *** Compliance Audits *** *** Product Complaints *** *** Change Management *** ***