Orchid's Piperacillin-Tazobactam ANDA gets FDA nod

Sirisha Pingali's picture
4.5
Your rating: None Average: 4.5 (6 votes)

India based pharma major - Orchid Chemicals and Pharmaceuticals has received approvals from FDA for its ANDAs for Piperacillin and Tazobactam. These are available in both vial and Bulk Dosage forms. Orchid is the "first applicant" and a 180day generic drug exclusivity was granted by FDA. The Indian firm has marketing and distribution partnership with Apotex a US based company. Speaking at a conference, Mr K Raghavendra Rao, Managing Director, Orchid said, “This is a great milestone in our US Generics journey. We are not only the first generic product to be approved but also have been granted 180-days generic drug exclusivity. These approvals demonstrate Orchid’s world-class technological and regulatory skills. Given the premium nature of this life-saving antibiotic and our first generic status with exclusivity, we anticipate significant contribution to our revenues and profitability from this product in the ensuing quarters.”
Anyways, this is a good start from our side..These sort of improvements in the near future helps us to raise our global image..

Reference:
Biospectrum - Business Of Life Sciences.

Juhi Sharma's picture

great acheivement!

Sirisha Pingali's picture

dear juhi.. thank you for

dear juhi..
thank you for your valuable comment..

Zarrin Faria's picture

A great blog..wonderful

5

A great blog..wonderful information...we should be really proud of this achievemnt being a part of the Indian pharma world...
Regards,
Faria Zarrin
Team: BLOGBUSTERS

Sirisha Pingali's picture

dear faria.. thank you for

dear faria..
thank you for your valuable comment..

Supriya vavilapalli's picture

dear sirisha, yes orchid had

5

dear sirisha,
yes orchid had really made india proud.............nice blog.......keep blogging

Supriya vavilapalli

THE COGNITIVE MOLECULES

http://www.pharmainfo.net/supriya-vavilapalli

Sirisha Pingali's picture

dear supriya.. thank you for

dear supriya..
thank you for your valuable comment..

Dr.S.Gunasakaran's picture

Teamwork

3

Orchid also received its first MA (Marketing Authorisation) approval for Piperacillin-Tazobactam in the EU market during the second quarter of this fiscal. This approval will spearhead the European generics foray in distribution partnership with Hospira, a leading global injectable generics player and will lead to a strong revenue base for the company in this geography from the current quarter onwards.

The product has already been launched in Australia through Hospira and in Canada through Apotex.

The extensive teamwork helps us in bringing out this magnificient launch in US, of being the first generic with data exclusivity for piperazillin tazobactam.

Dr.S.Gunasakaran,MBBS,MD

Sirisha Pingali's picture

sir.. thank you for your

sir..
thank you for your valuable comment..Please post your suggestions for our blogs..

Supriya vavilapalli's picture

good information sir

good information sir

Supriya vavilapalli

THE COGNITIVE MOLECULES

http://www.pharmainfo.net/supriya-vavilapalli

KHAN's picture

atleast

5

Atleast some one is gaining trust (Orchid) when others like Ranbaxy is loosing trust in Generic World in USA

Sirisha Pingali's picture

sir..thank you for your

sir..
thank you for your valuable comment..Orchid pharmaceuticals has really made India proud..In my view if we continue to work in some loopholes of our profession..definitely we can reach a peak level.