PIL- Thalidomide 50mg Hard Capsules: Change history

1.) To register the addition of Glutamine content test procedure

for the active substance thalidomide used in the manufacturing

process of the active substance.

2.) To register the addition of Bluepharma Industria Farmaceutica S.A., Eiras, Rua Adriano Lucas Coimbra,3020-

430 Portugal as an alternative site responsible for manufacturing of the finished product.

3.) To register the addition of Bluepharma Industria

Farmaceutica S.A., Eiras, Rua Adriano Lucas

Coimbra, 3020-430 Portugal as an alternative site responsible

for primary packaging of the finished product.

4.) To register the addition of Bluepharma Industria

Farmaceutica S.A., Eiras, Rua Adriano Lucas Coimbra, 3020-

430 Portugal as an alternative site responsible for secondary

packaging of the finished product.

5.) To register the addition of Bluepharma Industria

Farmaceutica S.A., Eiras, Rua Adriano Lucas Coimbra, 3020-

430 Portugal as an alternative site responsible for batch

release including batch testing of the finished product.

6.) To register the addition of Bluepharma Industria

Farmaceutica S.A., S. Martinho do Bispo Coimbra, 3045-016

Portugal as an alternative site responsible for batch release

including batch testing of the finished product.

7.) To register minor changes in the manufacturing process of

the finished product to change pre-blending and blending time,

and rpm.

8.) To register minor changes to the test procedure for the

excipient hard gelatine capsules to update the Average mass

method from n=20 to n=100 caps.

9.) To register minor changes to the related substance test

procedure for the finished product to update the RSD number

of injections.

10.) To widen the Total thickness specification limit for the

immediate packaging PVC/PCTFE for the finished product from

272 micrometres plus/minus 15 micrometres to 277

micrometres plus/minus 17 micrometres.

11.) To register the deletion of the non-significant parameter

Measurements from the immediate

packaging (LDPE bag) specifications of the finished product.

12.) To register the deletion of the non-significant parameter

Thickness from the immediate packaging

(LDPE bag) specifications of the finished product.

13.) To register the deletion of the non-significant parameter

Microbiological control from the immediate packaging (LDPE

bag) specifications of the finished product.

Consequentially, the label and leaflet have been updated.

[14.) IA, B.III.1.b.3 – Register an updated Gelatin TSE certificate from ROUSSELOT from R1-CEP 2000-029-Rev 05 to R1-CEP 2000-029-Rev 06, dated 06 June 2023.

15.) IA, B.III.1.b.3 – Register an updated Gelatin TSE certificate from TESSENDERLO GROUP N.V., Division PB Leiner (formerly PB Gelatins), from R1-CEP 2000-045-Rev 03 to CEP 2000-045-Rev 06, dated 24 January 2024.

16.) IA, B.III.1.b.3 – Register an updated Gelatin TSE certificate from NITTA GELATIN INDIA LTD from R1-CEP 2000-344-Rev 02 to R1-CEP 2000-344-Rev 03, dated 10 October 2019.

17.) IA, B.III.1.b.3 – Register an updated Gelatin TSE certificate from NITTA GELATIN INC., from R1-CEP 2005-217-Rev 00 to R1-CEP 2005-217-Rev 02, dated 16 July 2019.

18.) IA, B.III.1.b.4 – Register the deletion of gelatin TSE certificate R1-CEP 2004-247-Rev 00 from NITTA GELATIN INC.

19.) IA, B.III.1.b.4 – Register the deletion of gelatin TSE certificate R1-CEP 2004-320-Rev 00 from NITTA GELATIN INC.

20.) IA, B.III.1.b.2 – Register a new Gelatin TSE certificate R1-CEP 2008-048-Rev 00, dated 30 January 2014 from a new manufacturer, PIONEER JELLICE INDIA PRIVATE LIMITED.]

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