DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam.

Transcription

1 DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin: Name of the product : DXN GANOCELIUM (GL) 2. Composition : As enclosed in Annex I 3. Method of manufacture : As enclosed in Annex II 4. Precautions in manufacturing : As enclosed in Annex II 5. Product specification : As enclosed in Annex III Application for the license of manufacturing Ayurvedic medicines Patent and Proprietary Medicine of Capsule Category 6. Packaging and storage : Bottle pack of 30 caps, 90 caps and 360 caps, label enclosed, store in cool dry place. 7. Dosage : One capsule to be taken three times daily. 8. Vehicle : Water. 9. Time of dosage : Before meals. 10. Pharmacological action of : As enclosed in Annex I. Capsule DXN Ganocelium (GL) is useful in general weakness and improve body immune system. each ingredient and the drug 11. Indications : Useful as Balya and Poshak. 12. Side effects and remedy : No side effects have been reported. 13. Chemical testing report : DXN Ganocelium capsule constitutes of Ayurvedic herb which has been arrived at the basis of text reference and is a safe medicine. 14. Clinical trial report : If required, then it will be submitted after approval of product. 15. Declaration : Daehsan Biotech Private Limited will manufacture product name DXN GANOCELIUM (GL). 16. Additional information, if any : Keeping in view the above narrated facts, it is requested that the permission to manufacture the above said medicene may kindly be granted. 17. Signature of the Firm :

2 DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin: Composition along with pharmacological indication of each ingredient Each capsule contains 450 mg Annex I DXN GANOCELIUM (GL) CAPSULE No. Hindi / Sanskrit name Latin name Part used Properties Text reference Each capsule contains Quantity for 1 lakh cap 1 Chatrakh Ganoderma lucidum Mycelium Balya, poshak Charak Samhita 450 mg 45 kg Batch size: 100,000 capsules Text reference: Charak Samhita

3 DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin: Annex II DXN GANOCELIUM (GL) CAPSULE METHOD OF MANUFACTURE: The raw materials purchased from source are sent to store. Raw materials from store are collected for testing to quality control department. After the acceptance from quality control, the raw materials are sent to raw materials room and then production unit. In the production unit, the capsules are filled with mushroom powder in capsule filling machine at controlled temperature 20 C 25 C and room humidity at 41% - 45%. Filled capsules are sorted for breakage and polished in sorting and polishing machine and then are bottle packed. Bottle are packed in mono cartons and stored in quarantine room. The finished product is sent for testing to quality control and once accepted are sent to finished product store ready for dispatch. PRECAUTIONS DURING MANUFACTURING Powder should be dry while filling and should not adhere together or become moist.

4 PRODUCT SPECIFICATION DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin: Annex III DXN GANOCELIUM (GL) CAPSULE 1 Name of the product DXN GANOCELIUM (GL) 2 Description of capsule shell Capsule shell Size Category Description of powder Transparent capsule shell 1 Veg capsule Colour Odour Taste Mesh size Surface Pale yellow to yellow Characteristic Sweet to sourish 60 mesh Free flowing powder 4 Disintegration time 3 to 5 minutes 5 Average weight of Empty capsules Filled capsules Filling in the capsule (weight of powder) 75 mg (70 to 80 mg) 525 mg ± 7.5% 450 mg

5 Specimen label of DXN GANOCELIUM (GL) 30 / 90 / 360 CAPSULES DXN GANOCELIUM (GL) AYURVEDIC MEDICINE COMPOSITION: Each capsule contains: Chatrakh Mushroom 450 mg Dosage: One capsule to be taken three times daily. Indications: Balya and Poshak. Batch No. Date of Mfg. Date of Expiry M.R.P. incl. Of all taxes. Manufacturing Lic. No. Manufactured by: DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin:

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9 DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin: Name of the product : DXN REISHIGANO (RG) 2. Composition : As enclosed in Annex I 3. Method of manufacture : As enclosed in Annex II 4. Precautions in manufacturing : As enclosed in Annex II 5. Product specification : As enclosed in Annex III Application for the license of manufacturing Ayurvedic medicines Patent and Proprietary Medicine of Capsule Category 6. Packaging and storage : Bottle pack of 30 caps, 90 caps and 360 caps, label enclosed, store in cool dry place. 7. Dosage : One capsule to be taken three times daily. 8. Vehicle : Water. 9. Time of dosage : Before meals. 10. Pharmacological action of : As enclosed in Annex I, capsule DXN Reishigano (RG) is useful in general weakness and improve body immune system. each ingredient and the drug 11. Indications : Useful as Balya and Poshak. 12. Side effects and remedy : No side effects have been reported. 13. Chemical testing report : DXN Reishigano capsule constitutes of Ayurvedic herb which has been arrived at the basis of text reference and is a safe medicine. 14. Clinical trial report : If required, then it will be submitted after approval of product. 15. Declaration : Daehsan Biotech Private Limited will manufacture product name DXN REISHIGANO (RG). 16. Additional information, if any : Keeping in view the above narrated facts, it is requested that the permission to manufacture the above said medicine may kindly be granted. 17. Signature of the Firm :

10 DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin: Composition along with pharmacological indication of each ingredient Each capsule contains 270 mg Annex I DXN REISHIGANO (RG) CAPSULE No. Hindi / Sanskrit name Latin name Part used Properties Text reference Each capsule contains Quantity for 1 lakh cap 1 Chatrakh Ganoderma lucidum Fruit body Balya, poshak Charak Samhita 270 mg 27 kg Batch size: 100,000 capsules Text reference: Charak Samhita

11 DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin: Annex II DXN REISHIGANO (RG) CAPSULE METHOD OF MANUFACTURE: The raw materials purchased from source are sent to store. Raw materials from store are collected for testing to quality control department. After the acceptance from quality control, the raw materials are sent to raw materials room and then production unit. In the production unit, the capsules are filled with mushroom powder in capsule filling machine at controlled temperature 20 C 25 C and room humidity at 41% - 45%. Filled capsules are sorted for breakage and polished in sorting and polishing machine and then are bottle packed. Bottle are packed in mono cartons and stored in quarantine room. The finished product is sent for testing to quality control and once accepted are sent to finished product store ready for dispatch. PRECAUTIONS DURING MANUFACTURING Powder should be dry while filling and should not adhere together or become moist.

12 PRODUCT SPECIFICATION DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin: Annex III DXN REISHIGANO (RG) CAPSULE 1 Name of the product DXN REISHIGANO (RG) 2 Description of capsule shell Capsule shell Size Category Description of powder Transparent capsule shell 1 Veg capsule Colour Odour Taste Mesh size Surface Brown to dark brown Characteristic Bitter 60 mesh Free flowing powder 4 Disintegration time 3 to 5 minutes 5 Average weight of Empty capsules Filled capsules Filling in the capsule (weight of powder) 75 mg (70 to 80 mg) 345 mg ± 7.5% 270 mg

13 Specimen label of DXN REISHIGANO (RG) 30 / 90 / 360 CAPSULES DXN REISHIGANO (RG) AYURVEDIC MEDICINE COMPOSITION: Each capsule contains: Chatrakh Mushroom 270 mg Dosage: One capsule to be taken three times daily. Indications: Balya and Poshak. Batch No. Date of Mfg. Date of Expiry M.R.P. incl. Of all taxes. Manufacturing Lic. No. Manufactured by: DAEHSAN BIOTECH PRIVATE LIMITED Industrial Growth Centre, Assam Industrial Development Corporation, Balipara, Sonitpur, Assam. Pin:

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