Bioequivalence and Bioavailability Forum

Dear Mr.Rave,

If the drugs are approved in the 2007 and the drug is available in the Indian market for more than 04 years, then there is no need for BE NOC. However, you may need to apply for T License if your are planning to import the investigational product from foreign countries in case if your are planing to conduct the above two studies for USFDA/EMEA/other foreign regulatory bodies.

❝ Rest two are Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg FDC & Levonorgestrel 0.75 mg but we are manufacturing them for more than 4 years. please help!!!

Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg FDC was approved by CDSCO on 13.10.10.
Ref: http://cdsco.nic.in/LIST%20OF%20APPROVED%20DRUG%20FROM%2001.htm

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]