Label Formula:

Mecobalamin ,Alpha Lipoic Acid, Benfothiamine ,Vitamin B6 , Calcium Pantothenate, Folic

Acid Zinic Oxide , Chromium picolinate, Inositol and leutin Capsules
 DRAFT LABEL
Each capsule contains

Mecobalamin 1500mcg
Alpha Lipoic Acid USP 100 mg
Benfotiamine 15 mg
Vitamin B6 IP 3 mg
Calcium Pantothenate IP 25 mg
Folic Acid IP 1.5 mg
Zinc Oxide IP 22.5 mg
Chromim Picolinate USP 65 mcg
Inositol BP 10 mcg
Leutin USP 5 mg
Excipients qs

Dosage: As directed by the Physician. Storage: Keep in a Cool Dry

Place. Protect from light.
Mfg License No: 564 MB
Batch No:
Mfg Date :
Exp Date : FOR THERAPEUTIC USE
MRP Rs :
(Inclusive of all taxes)

Manufactured By:
Aaron Babcon (India) Pvt. Ltd.
766, Garia Main Road ; Kolkata : 700 084 .
 MANUFACTURING PROCEDURE
Batch Size : 50,000 capsules

Master Formula

Serial Ingredients Composition per Quantity for 50,000

No Capsule (mg) capsules
Active Ingredient
1 Mecobalamin 1500mcg 75 g
2 Alpha Lipoic Acid USP 100 mg 5 kg
3 Benfotiamine 15 mg 0.75 kg
4 Vitamin B6 IP 3 mg 0.15 kg
5 Calcium Pantothenate IP 25 mg 1.25 kg
6 Folic Acid IP 1.5 mg 0.075 kg
7 Zinc Oxide IP 22.5 mg 1.125 kg
8 Chromim Picolinate USP 65 mcg 3.25 g
9 Inositol BP 10 mcg 0.5 g
10 Leutin USP 5 mg 250 g

Step 1
Weigh each of the ingredient in a dispensing booth.

Step 2
Pass all the ingredients through a sieve shaker

Step 3
Mix all the ingredients in a cone blender for 15.0 min

Step 4
Fill the mixture in ‘Size 2’ capsule

Step 5
Polishing of capsules

Step 6
Blister
 STANDARD TESTING PROTOCOL

Ingredient Testing Protocol Reference

1 Mecobalamin USP Page No:
2 Alpha Lipoic Acid USP USP Page No :
3 Benfotiamine HPLC ; Reference International
Journal of Analytical and
Bioanalytical Chemistry ; ISSN-
2231-5012 ;attached
4 Vitamin B6 IP IP 2014 ; Page 2600-2601
5 Calcium Pantothenate IP IP 2014 ; Page 1257
6 Folic Acid IP IP 2014; Page No 1821 -1822
7 Zinc Oxide IP IP 2014; Page 3010
8 Chromim Picolinate USP USP Page No:
9 Inositol BP BP Page No:
10 Leutin USP USP Page No:

REFERENCE PRODUCT
FIXED DOSE COMBINATIONS APPROVED BY DCG (I) SINCE 1961 NO : 778 ; date of
Approval 30/01/2008
 Label Formula:
Mecobalamin ,Alpha Lipoic Acid, Benfothiamine ,Pyridoxine , Biotin and Folic Acid Capsules
 DRAFT LABEL

Each capsule contains

Mecobalamin 500 mcg
Alpha Lipoic Acid USP 200 mg
Benfotiamine 10 mg
Pyridoxine IP 3 mg
Biotin USP 5 mg
Folic Acid IP 1.5mg
Excipients qs

Dosage: As directed by the Physician. Storage: Keep in a Cool Dry

Mfg License No: 564 MB Place. Protect from light.
Batch No:
Mfg Date :
Exp Date : FOR THERAPEUTIC USE
MRP Rs :
(Inclusive of all taxes)

Manufactured By:
Aaron Babcon (India) Pvt. Ltd.
766, Garia Main Road ; Kolkata : 700 084 .
 MANUFACTURING PROCEDURE
Batch Size : 50,000 capsules

Master Formula

Serial Ingredients Composition per Quantity for 50,000

No Capsule (mg) capsules
Active Ingredient
1 Mecobalamin 500mcg 25 g
2 Alpha Lipoic Acid USP 200 mg 10 kg
3 Benfotiamine 10 mg 0.5 kg
4 Vitamin B6 IP 3 mg 0.15 kg
5 Biotin USP 5mg 0.25 kg
6 Folic Acid IP 1.5 mg 75 g

Step 1
Weigh each of the ingredient in a dispensing booth.

Step 2
Pass all the ingredients through a sieve shaker

Step 3
Mix all the ingredients in a cone blender for 15.0 min

Step 4
Fill the mixture in ‘Size 2’ capsule

Step 5
Polishing of capsules

Step 6
Blister
 STANDARD TESTING PROTOCOL
Ingredient Testing Protocol Reference
1 Mecobalamin USP Page No:
2 Alpha Lipoic Acid USP USP Page No :
3 Benfotiamine HPLC ; Reference International
Journal of Analytical and
Bioanalytical Chemistry ; ISSN-
2231-5012 ;attached
4 Vitamin B6 IP IP 2014 ; Page 2600-2601
5 Biotin USP USP ; Page No
6 Folic Acid IP IP 2014; Page No 1821 -1822

REFERENCE PRODUCT
FIXED DOSE COMBINATIONS APPROVED BY DCG (I) SINCE 1961 NO : ; date of Approval
 Label Formula:
Methylcobalamin Vitamin C, Vitamin B6 , Folic Acid and Carbonyl Iron Capsules
 DRAFT LABEL

Each capsule contains

Methylcobalamin 500mcg
Vitamin C IP 75 mg
Vitamin B6 IP 10 mg
Folic Acid IP 5 mg
Carbonyl Iron 100 mg
Excipients qs

Dosage: As directed by the Physician. Storage: Keep in a Cool Dry

Mfg License No: 564 MB Place. Protect from light.
Batch No:
Mfg Date :
Exp Date : FOR THERAPEUTIC USE
MRP Rs :
(Inclusive of all taxes)

Manufactured By:
Aaron Babcon (India) Pvt. Ltd.
766, Garia Main Road ; Kolkata : 700 084 .
 MANUFACTURING PROCEDURE
Batch Size : 50,000 capsules

Master Formula

Serial Ingredient Weight for 1 capsule Weight for 50,000

No capsules (kg)
Active Ingredient
Methyl cobalamin 500 mcg 0.025
Vitamin C IP 75 mg 3.75
Vitamin B6 IP 10 mg 0.5
Folic Acid IP 5 mg 0.25
Carbonyl Iron 100 mg 5

Step 1
Weigh each of the ingredient in a dispensing booth.

Step 2
Pass all the ingredients through a sieve shaker

Step 3
Mix all the ingredients in a cone blender for 15.0 min

Step 4
Fill the mixture in ‘Size 2’ capsule

Step 5
Polishing of capsules

Step 6
Blister
 TESTING PROTOCOL

Methylcobalamin :

Vitamin C IP : (Ascorbic Acid ) : Page 1086 ; IP 2014

Vitamin B6 IP : (Pyridoxine Hydrochloride) Page 2600 -2601 IP 2014

Folic Acid IP: Page 1821 -1822 IP 2014

REFERENCE
FIXED DOSE COMBINATIONS APPROVED BY DCG (I) SINCE 1961 NO : ; date of Approval
 LABEL FORMULA

Pantaprazole (Enteric Coated) and Domperidone (Sustain Release) Capsules

 DRAFT LABEL
Each Capsule contains

Pantaprazole Sodium IP
Equivalent to
Pantaprazole (Enteric Coated) 40 mg
Domperidone Maleate IP
Equivalent to
Domperidone (Sustain Release) 30 mg

Dosage: As directed by the Physician. Storage: Keep in a Cool Dry

Mfg License No: 564 MB Place. Protect from light.
Batch No:
Mfg Date :
Exp Date : SCHEDULE ‘H’ DRUG
MRP Rs :
Warning: To be sold by retail on
(Inclusive of all taxes)
the prescription of a registered
Manufactured By: medical practitioner only.
Aaron Babcon (India) Pvt. Ltd.
766, Garia Main Road ; Kolkata : 700 084 .
 MANUFACTURING PROCEDURE
Batch Size : 50,000 capsules

Master Formula

Serial Ingredients Composition per Quantity for 50,000

No Capsule (mg) capsules (kg)
Active Ingredient
1 Pantaprazole Sodium IP 45.23 2.27 kg
2 Domperidone Maleate IP 38.18 1.91 kg
In active Ingredient
1 Lactulose 116.59 5.83 kg

Step 1
Weigh each of the ingredient in a dispensing booth.

Step 2
Pass all the ingredients through a sieve shaker

Step 3
Mix all the ingredients in a cone blender for 15.0 min

Step 4
Fill the mixture in ‘Size 2’ capsule

Step 5
Polishing of capsules

Step 6
Blister
 TESTING PROTOCOL

Pantaprazole Sodium : IP 2014 page No : 2426 - 2427

Domperidone Maleate : IP 2014 page No : 1613

REFERENCE
FIXED DOSE COMBINATIONS APPROVED BY DCG (I) SINCE 1961 NO : ; date of Approval 30