GOVERNMENT OF N.C.

T OF DELHI, DRUG CONTROL DEPARTMENT, 4th FLOOR, F-17, KARKARDOOMA, DELHI- 110032 CERTIFICATE OF PHARMACEUTICAL PRODUCT AS PER GMP
Certificate No. GMP/CERT/PROD/1615-1616/1997

Dated: 1 1.1 1.2 1.3 Names (if Applicable) and dosage form : LV-SIN

Exporting Country Importing Country

: :

INDIA NIGERIA

Active Ingredient2 (s) and amount(s) per unit dose3: Each film coated Tablets contains: Levofloxacin 500mg, colour sunset yellow + titanium dioxide. Is this product licensed to placed on the market for use in the exporting country?5 YES} As Product is permitted for export purpose only. Same product as per Is this product actually in the market in the exporting country ? YES} Indian Pharmacopoeia Standard is marketed in the exporting country A B 2B.1 Applicant for certificate (Name and Address)

2A.1 2A.2

Number of product license and date of issue : 1615&1616, dated 31-07-1997 Product license holder: (Name and Address) Abyss Pharma Pvt. Ltd B-121 Phase 1 Mayapuri, Industrial Area New Delhi, India-110064.

2A.3 2A3.1

Status of Product License holder8 : a. MANUFACTURER EXPORTER For category B & C the name and address of manufacturer producing the dosage form9 : N.A

2B.2 2B.3

Status of Applicant : Why is authorization lacking not not requested under consideration refused

2A.4 2A.5 2A.6

Is an approved summary basis appended10? NO Is the attached product information complete and consonance with the licence11? YES Applicant for certificate if different from the license holder : NA. (Name and address)
12

required 2B.3.1

or 2B2.1 Mfr. Remark13:

3. 3.1 3.2 3.3 4.

Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced? Periodicity of routine inspection (Years) Has the manufacture of this type of dosage form been inspected: Do the facilities and operations conform to Good Manufacturing Practices as per Indian Drugs and Costmetics Acts?15 Does the information submitted by the applicant satisfy the certifying authority in all aspect of the manufacture of the product?16

YES ONCE IN A YEAR YES YES YES

This certificate is valid upto 2 years from the date of issue. Address of Certifying Authority Drug Control Department, 4th Floor, F-17 Karkardooma, Shahdara Delhi- 110032