PXL/HO/BEC-003/2021-22 Dt: 17.04.2021
Subject: Trade query from Brazilian company for urgent import of medicine from India-Reg
Pharmexcil is in receipt of communication from Consulate General of India, Sao Paulo, wherein a Brazilian company named “M/s Osteofix (Grupo Fix), importer and distributor of medicines (information from Osteofix is attached herewith), seeking support for access to drug manufacturers for prompt supply of medicines from India as shown in the table below:
Sl. No.
|
Therapeutic Indication
|
Product Description
|
Unit Package
|
No. of Units per shipment
|
Estimated Annual Requirement
|
Approx. Target
CIF
US$/Unit
|
Remarks
|
1
|
Sedative-hypnotic agent, Intensive Care Unit (ICU) sedation
|
Propofol 200mg (10mg/mL), 20 mL; Injectable Emulsion
|
5 Ampoules per box
|
50.000 (Ampoules)
|
500.000
|
0,50
|
Emergency❗️
(prompt shipment)
|
2
|
skeletal muscle relaxation
|
Cisatracurium Besilate10mg (2mg/mL), 5mL, Injectable
|
10 Ampoules per box
|
15.000 (Ampoules)
|
150.000
|
0,89
|
Emergency❗️
(prompt shipment)
|
3
|
Induction of general anesthesia
|
Midazolam 50mg (5mg/mL) 10mL, Injectable
|
5 Ampoules per box
|
50.000 (Ampoules)
|
500.000
|
0,79
|
Emergency❗️
(prompt shipment)
|
4
|
skeletal muscle relaxation
|
Rocuronium bromide 50mg (10mg/mL) 5mL, Injectable
|
5 Ampoules per box
|
15.000 (Ampoules)
|
200.000
|
1,93
|
Emergency❗️
(prompt shipment)
|
The company has also shared information to the mission about the Brazilian legislation (copy attached) which has included India as one of the countries where from Brazilian companies can import medicines, provided the drugs must be registered with Central Drugs Standard Control Organization (CDSCO) and the factory must have a certificate of good manufacturing practices issued by Central Drugs Standard Control Organization (CDSCO).
In view of the regulatory requirements mentioned above, the Brazilian company wishes the interested Indian manufacturers to provide the following documents in advance: GMP – Good Manufacturing Practice and Product Registration, both from Central Drugs Standard Control Organization (CDSCO), analytical quality control methodology report for each product, and medicine information leaflet.
The Brazilian company also requires the following documents with product import: COA - batch release certificate for the product.
The Airport destination is: Guarulhos – São Paulo – Brazil.
The details of the Brazilian company are as follows:
Mr. Rander Avelar,
Director Presidente,
Grupo Fix / M/s Osteofix
Email: avelar@fixgrupo.com.br
Contact No: +55 61 98134-8692
Members who are able to fulfil the regulatory criteria as per the Brazilian legislation and the advance document requirement of the Brazilian company as mentioned above, may reach out directly to the Brazilian company.
With regards
Uday Bhaskar
Director General
Encl:
BEC003202122Osteofix.pdf
BEC003202122ResolutionNo.489.pdf
Disclaimer:
Members may please note that the above information is circulated on the basis of information received from our Mission in Sao Paulo regarding Trade enquiry from M/s. Ostofix. Members are advised to kindly go the legislations attached and make their own decisions before finalizing their business transactions.
Members who have got Business orders from Brazil Company are requested to share the order details with Pharmexcil.
|