DOBLE 40 mg CAPSULE

(Duloxetine 40 mg)

Product description : Delayed release pellets filled in hard

Content weight of capsule
Presentation
No. of capsules per batch
No. of packs per batch
Packaging material
Each capsule contains
gelatin capsules (shell # 3).
: 149.733 mg (±10.0%)
: 2 x 7’s = 14 capsules
: 300,000 capsules
: 21,428 packs
: Alu/Alu blisters in cardboard carton with
insert.

Duloxetine (as Hydrochloride) = 40 mg

Formulation

No. Ingredients RM Specs Function mg / unit kg / batch

Duloxetine Hydrochloride Delayed
1 Manufacturer’s specs API 199.644 59.893
Release Pelletes (22.5 %)
2 Hard gelatin cap # 3 Manufacturer’s specs - 52.000 15.600

Production Capacity

 One batch can be manufactured in one shift.

 Packaging of one batch can be done in one shift.

__________________
Head of
Product Development

Page 1 of 2
 DOBLE 40 mg CAPSULE
(Duloxetine 40 mg)

MANUFACTURING PROCEDURE

Precautions

1. Follow Good Manufacturing Practices for the manufacturing of pharmaceutical

specialties.
2. Workers directly handling the products must wear gloves and masks.

Procedure

1. Encapsulate the Duloxetine Hydrochloride Delayed Release Pelletes (22.5 %)

at 199.644 mg per capsule in shell # ‘’3’’ using encapsulation machine.

2. Sample to QA for analysis.

3. After the release from QA, blister the capsules using the recommended tooling.

Critical steps

1. Weight the ingredients carefully.

2. Check average weight after every 30 minutes during encapsulation.

__________________
Head of
Product Development

Page 2 of 2