Annexure –II

Annexure to Biological Drug Manufacturing License No.:………. Of

M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur

Drug Admin. Name of the product, Composition

(Triclabendazole BP(Vet) 900mg & Levamisole
Reg. No.
Hydrochloride BP 708.0 mg equivalent to Levamisole
600mg )/ bolus (VET)
Each Bolus Contain

Active Ingredient Specification Quantity Overage

Triclabendazole BP 900 mg
Levamisole Hydrochloride BP 708 mg
equivalent to
Levamisole 600mg
Inclusion Excipients
Date: Maize Starch BP 1557 mg
Colloidal Anhydrous Silica BP 25 mg
Povidone K-30 BP 100 mg
Microcrystalline Cellulose BP 1410 mg
Product Magnesium Stearate BP 50 mg
Valid Up to: Purified Talc BP 50 mg
Sodium Starch Glycolate BP 200 mg

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
 Annexure to Biological Drug Manufacturing License No.:………. Of
M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur

Drug Admin. Name of the product, Composition

Reg. No. Ciprofloxacin Hydrochloride  USP 1165 mg equivalent to
Ciprofloxacin 1000 mg/ bolus (VET)
Each Bolus Contain

Specificatio
Active Ingredient Quantity Overage
n
Ciprofloxacin BP 1165 mg
Hydrochloride
equivalent to
Ciprofloxacin 1000 mg
Excipients
Inclusion
Lactose BP 840 mg
Date: Maize Starch BP 1365 mg
Povidone K-30 BP 20 mg
Microcrystalline Cellulose BP 450 mg
Product Magnesium Stearate BP 20 mg
Valid Up to: Purified Talc BP 40 mg
Sodium Starch Glycolate BP 100 mg

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
 Annexure to Biological Drug Manufacturing License No.:………. Of
M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur

Drug Admin. Name of the product, Composition

Reg. No. Sulfadiazine BP 400 mg and Trimethoprim BP 80 mg / ml
suspension (VET)
Each ml Contain

Specificatio Overag
Active Ingredient Quantity
n e
Sulfadiazine BP 400 mg
Trimethoprim BP 80 mg

Excipients
Inclusion Sodium Carboxymethyl BP 3.00 mg
Date: Cellulose
Saccharine Sodium BP 1.50 mg
Methyl Parahydroxy BP 1.75 mg
Benzoate
Propyl Parahydroxy Benzoate BP 0.18 mg
Product Propylene Glycol BP 20.00 mg
Valid Up to: Polysorbate 80 BP 2.00 mg
Colloidal Anhydrous Silica BP 1.20 mg
Simethicone 30% BP 0.50 mg
Purified Water qs to BP 1 ml

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
Annexure to Biological Drug Manufacturing License No.:………. Of
 M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur

Drug Name of the product, Composition

Admin. Reg. Levofloxacin Hemihydrate USP 102.5 mg equivalent to
No. Levofloxacin 100 mg / ml solution (VET)

Each ml Contain

Overag
Active Ingredient Specification Quantity
e
Levofloxacin Hemihydrate USP 102.5 mg
(equivalent to
Levofloxacin 100 mg )

Excipients
Inclusion
Glycerin BP 50 mg
Date:
Sodium Hydroxide BP 1.5 mg
Sodium Chloride BP 1.5 mg
Product Purified Water qs to BP 1 ml
Valid Up to:

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
Annexure to Biological Drug Manufacturing License No.:………. Of
M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur
Drug Name of the product, Composition
Admin. Reg.
No. Ketoprofen BP 100 mg / ml Injectable solution (VET)

Each ml Contain

Specificatio Overag
Active Ingredient Quantity
n e
Ketoprofen BP 100 mg

Excipients
Inclusion
L-Arginine BP 5.750 mg
Date:
Benzyl Alcohol BP 1.920 mg
Citric Acid Monohydrate BP 0.140 mg
Sodium Hydroxide BP 0.475 mg
Product Water For Injection qs to BP 1 ml
Valid Up to:

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
Annexure to Biological Drug Manufacturing License No.:………. Of
M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur
Drug Name of the product, Composition
Admin. Reg.
No. Ivermectin BP 10 mg / ml Injectable solution(VET)

Each ml Contain

Specificatio Overag
Active Ingredient Quantity
n e
Ivermectin BP 10 mg

Excipients
Inclusion
Propylene Glycol BP 850.00 mg
Date:
Benzyl Alcohol BP 10.00 mg
Glycerol BP 130.00 mg
Product
Valid Up to:

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
Annexure to Biological Drug Manufacturing License No.:………. Of
M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur
Drug Admin. Name of the product, Composition
Reg. No. Oxytetracycline Dihydrate BP 215.64 mg equivalent to
Oxytetracycline BP 200 mg / ml Injectable solution(VET)
Each ml Contain

Specificatio Overag
Active Ingredient Quantity
n e
Oxytetracycline BP 215.65 mg
Dihydrate
(equivalent to
Oxytetracycline BP 200
mg )

Excipients
Inclusion Sodium Formaldehyde BP 6.00 mg
Sulfoxylate (42.51%)
Date:
Monoethanolamine BP 67.00 mg
(98.85%)
2-Pyrrolidone (Soluphor- BP 520.00 mg
P)
Magnesium Chloride BP 80.00 mg
Hexahydrate
Citric Acid BP 5.00 mg
Product
Water For Injection qs BP 1 ml
Valid Up to:
to

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
Annexure to Biological Drug Manufacturing License No.:………. Of
M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur
Drug Admin. Name of the product, Composition
Reg. No. Synthetic Oxytocin BP 17 mcg equivalent to Oxytocin BP
10 IU / ml Injectable solution(VET)
Each ml Contain

Specificatio Overag
Active Ingredient Quantity
n e
Synthetic Oxytocin BP 0.017 mg
(equivalent to Oxytocin
BP 10 IU)

Excipients
Inclusion
Chlorobutanol BP 4.75 mg
Date:
Hemihydrate
Sodium Chloride BP 2.00 mg
Acetic acid BP 2.50 mg
Product Valid Water For Injection qs to BP 1 ml
Up to:

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
Annexure to Biological Drug Manufacturing License No.:………. Of
M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur
Drug Admin. Name of the product, Composition
Reg. No. Gonadorelin Acetate BP 105 mcg eq. to Gonadorelin 100
mcg / ml Injectable solution(VET)
Each ml Contain

Specificatio Overag
Active Ingredient Quantity
n e
Gonadorelin Acetate BP 0.105 mcg
(equivalent to
Gonadorelin 100 mcg)
Inclusion
Date:
Excipients
Sodium Chloride BP 6.00 mg
Product Benzyl Alcohol BP 20.00 mg
Valid Up to: Water For Injection qs to BP 1 ml

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh

Annexure –II
Annexure to Biological Drug Manufacturing License No.:………. Of
M/S SHINIL Pharma Ltd. B K Bari, Mirzapur, Gazipur
Drug Admin. Name of the product, Composition
Reg. No. Dinoprost Tromethamine BP 6.7 mg equivalent to
Dinoprost 5 mg / ml Injectable solution(VET)
Each ml Contain

Specificatio Overag
Active Ingredient Quantity
n e
Dinoprost Tromethamine BP 6.70 mg
(equivalent to Dinoprost
5 mg)

Inclusion Excipients
Date: Benzyl Alcohol BP 16.50 mg
Sodium Hydroxide BP 2.00 mg
Product Valid Water For Injection qs to BP 1 ml
Up to:

Major General Md. Mustafizur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority ( Drugs)
Govt. of the People’s Republic of Bangladesh