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 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. 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) 000-0000 Ph: (252) 707-2182 Fax: (919) 000-0000 Fax: (252) 707-7306 Dgilbert@xxxxx.xxx jwilliams@catalytica-pharm.xxx -------------------------------------------- ----------------------------------------- -------------------------------------------- QC Testing Donna Gilbert Kirit Amin Ph: (919) 490-0000 Ph: (252) 707-2372 Fax: (919) 000-0000 Fax: (252) 707-7027 Dgilbert@xxxxx.xxx kamin@catalytica-pharm.com -------------------------------------------- ----------------------------------------- -------------------------------------------- Investigations Donna Gilbert Kathleen Bussell Ph: (910) 000-0000 Ph: (252) 707-2128 Fax: (919) 000-0000 Fax: (252) 707-2207 Dgilbert@xxxxx.xxx kbussell@catalytica-pharm.cxx -------------------------------------------- ----------------------------------------- -------------------------------------------- Stability Donna Gilbert Kirit Amin Ph: (919) 490-0000 Ph: (252) 707-2372 Fax: (919) 000-0000 Fax: (252) 707-7027 Dgilbert@xxxxx.xxx kamin@catalytica-pharm.com -------------------------------------------- ----------------------------------------- -------------------------------------------- Regulatory Affairs Donna Gilbert Beverly Lewis Ph: (919) 000-0000 Ph: (252) 707-7913 Fax: (919) 000-0000 Fax: (252) 707-2326 Dgilbert@xxxxx.xxx Blewis@catalytica-pharm.com -------------------------------------------- ----------------------------------------- -------------------------------------------- Validation Donna Gilbert Frank Anasti Ph: (919) 400-0000 Ph: (252) 707-2651 Fax: (919) 000-0000 Fax: (252) 707-7678 Dgilbert@xxxxx.xxx Fanasti@catalytica-pharm.cox -------------------------------------------- ----------------------------------------- -------------------------------------------- Compliance Audit...
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. 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. APPENDIX I The PRODUCTS Provigil 100 mg, bulk tablets Provigil 100 mg, 30 count blister Provigil 100 mg, 100 count bottle Provigil 200 mg, bulk tablets Provigil 200 mg, 6 count bottle Carton x 2 bottles Provigil 200 mg x 100 count
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] APPENDIX I: SPECIFICATIONS FOR THE PRODUCTS QUALITY AGREEMENT • Zimycan ointment 0xx, 00xx, & 60gm APPENDIX II: LIST OF QUALITY CONTACTS QUALITY AGREEMENT ISSUE BARRIER DSM Product Release *** *** QC Testing *** *** Investigations *** *** Regulatory Affairs *** *** Validation *** *** Compliance Audits *** *** Product Complaints *** *** Change Management *** *** APPENDIX III: RELEASE DOCUMENTATION The lot release document package will include a Certificate of Analysis (“COA”) and a Certificate of Compliance (“COC”). Certificate of Analysis: A COA which is generated by DSM Quality Assurance/Regulatory Affairs will be provided and will include the name of the Products, lot number, date of manufacture, and analytical specifications. The COA will list the release tests performed by DSM laboratories (and/or qualified third-party laboratories) and actual test results.
