04 Jul 2016
Reply
Enquiry//eCTD Dossiers required for various products [ENA00027]
Bilcare, a reliable and credible long-term partner of the global pharmaceutical industry for Clinical Trial Material Supplies has received requests for the following products -
1. Colesevalam tablets 625 mg for US market.
2. Nitrofurantoin capsules 50/ 100mg for UK, South Africa, Italy and Croatia markets
3. Cetirizine tablets 20 mg for Canada /Us/EU market
4. Colchicine tablets 0.5 mg for UK market
5. Carbimazole tablets 5 & 20 mg for UK market
6. Tolterodine ER capsule 2/4 mg for US market
7. Sevelamer Carbonate tablets 800 mg for US market
8. Sevelamer suspension for US
9. Carbidopa tablets for EU.
10. Azithromycin 250 mg capsules for EU
11. Mesalamine 1200 mg tabs for EU
12. Mesalazine 400 mg and 800 mg for EU
13. Alimemazine 10mg tab for EU
14. Hydrocortisone 10 mg tab for EU
15. Diclofenac sod.3%, sodium hyaluronate 2.5% (Solaraze) for EU
16. Ciprofibrate 100 mg tab for EU
17. Hydroxy urea capsules for US/EU
18. Tamoxifen citrate tabs for US/EU
19. Gefitinib tabs for US/EU
20. Sunitinib capsules for US/EU
21. Lacosamide for EU
22. Aripiprazole tabs for US
23. Darifenacin ER for US
24. Memantine tablets 5/10mg, Oral solution 2mg/ml, ER capsules 7/14/21/28mg for US,
25. Memantine ER + Donepezil capsules 14mg+10mg/ 28mg+10mg for US
Interested companies should respond immediately to Chhanda Das, VP-QA and Regulatory, Bilcare Limited at Chhanda.Das_GCS@bilcare.com.
1. Colesevalam tablets 625 mg for US market.
2. Nitrofurantoin capsules 50/ 100mg for UK, South Africa, Italy and Croatia markets
3. Cetirizine tablets 20 mg for Canada /Us/EU market
4. Colchicine tablets 0.5 mg for UK market
5. Carbimazole tablets 5 & 20 mg for UK market
6. Tolterodine ER capsule 2/4 mg for US market
7. Sevelamer Carbonate tablets 800 mg for US market
8. Sevelamer suspension for US
9. Carbidopa tablets for EU.
10. Azithromycin 250 mg capsules for EU
11. Mesalamine 1200 mg tabs for EU
12. Mesalazine 400 mg and 800 mg for EU
13. Alimemazine 10mg tab for EU
14. Hydrocortisone 10 mg tab for EU
15. Diclofenac sod.3%, sodium hyaluronate 2.5% (Solaraze) for EU
16. Ciprofibrate 100 mg tab for EU
17. Hydroxy urea capsules for US/EU
18. Tamoxifen citrate tabs for US/EU
19. Gefitinib tabs for US/EU
20. Sunitinib capsules for US/EU
21. Lacosamide for EU
22. Aripiprazole tabs for US
23. Darifenacin ER for US
24. Memantine tablets 5/10mg, Oral solution 2mg/ml, ER capsules 7/14/21/28mg for US,
25. Memantine ER + Donepezil capsules 14mg+10mg/ 28mg+10mg for US
Interested companies should respond immediately to Chhanda Das, VP-QA and Regulatory, Bilcare Limited at Chhanda.Das_GCS@bilcare.com.
balu.kontact@gmail.com
Hi I have a dossier under dcp filing for Hydrocortisone 10mg and 20mg do let me know volumes of EU market
best regards
Balu
balu.kontact@gmail.com
22:53, 26 Jul 2016
laura.olteanu@qualitypharmserv.com
Dear Balu,
I am also interested in the Hydrocortizone 10 mg and 20 mg dossier in EU-CTD and with registration by DCP, for UK, for one of our customers.
Can y ou give me updated information, please?
Many thanks! Best regards.
Laura
21:39, 28 Oct 2016
