In the document shared, its clear that bortezomib was filed with a partner, so the ANDA will be in the name of the partner (and not gland pharma).
The ANDA approval letter on FDA website doesn’t provide details on API or medical device supplier. In some instances, you can find the label where manufacturer name will be mentioned.
Where can I look for ANDA application on US FDA site
I have picked up one drug from Gland Pharma
First I have looked up on FDA Orange Book , took the chemical entity name and then looked up the below site
I can’t find any Gland Pharma reference anywhere in the document and unable to locate the original ANDA application.
I am trying to understand all the parties involved to manufacture this medicine, API providers, syringe providers etc…
One more observation is Gland reported it on 4th May 2002 that they have approval from USFDA where as on the US FDA site it shows it is approved in 2013 .
@harsh.beria93 or any pharma experts please help me to understand this better
If you or anyone can share how much of their current overall housing loan book and current quarter growth is from developer loans and how much from retail, would be helpful…
I would also tend to believe that Neuland is one company which has high promise but the delivery fall far short of expectations. This obviously has to do with the competitive Generic industry in which they operate. Even the CSM segment is not able to scale up significantly over the last many quarters. The molecules that they are working on are fairly challenging and complex and taking them to the finish line (themselves and for the partner) is always going to be challenging.
In nutshell, I believe given the industry that they are in and the complexities of FDA/Technical etc and their small size, it is not going to become a secular growth story for some time. even if they do well in 1-2 quarter, business may revert back to mean margins and growth thus disappointing investors. The only way to play this can be buying at fairly low valuations and then hoping for management to deliver numbers for 1-2 quarter and moving out after making some trading profits.
Regards,
NIkhil
Disc: Not invested but following.
The Q1FY23 result is awesome. All thanks to whooping export growth!!
growth guidance from delivering 18-20% revenue growth to delivering 20%+ revenue growth.
What is the problem withthis CO? Consectively giving poor results including the Q1-23. What are the future prospects?
Attended AGM today: Based on Share holder speakers Queries management responses: 1.Oracle Corp Parent CO advantage gives them direct entry into big ticket clients .with Zero cost they use the overseas offices of Oracle Corp without any overhead costs. 2. They believe in margins and value than volume. 3.Migration of clients from legacy Software to Cloud is taking some time. Revenue sharing to Cloud platforms they are yet to work out. 4.Huge cash RESERVES are kept for any attractive valuations available for acquisitions in Startup space. 5.No change in dividend Policy and will be continued. So my reading is the Parent Company is very conservative in approach and will take UP only High margin projects. We can not expect high Growth but dividends are going to be much attractive with a possibility of Special dividend also next year. As of now doesn’t look like any delisiting in near future!
Management reply for bonus issue:
“We are even in an expansion mode but there are regulatory responsibilities which are also increasing and our prime focus as MII is to ensure the regulatory responsibilities, that thrust in the system is being built, technology also is our second focus . We have all seen that there have been huge amount of attrition all around especially in the IT sector but also in the other areas so to get the right people, the right expertise you need to ensure that you adequately compensating.”
“I will say that we need to understand that CDSL is on a growth trajectory and two principle costs are technology and employees. So we need the right people and we need to expand our employee teams to kind of garner and able to achieve the increased growth on a sustainable basis both from a business standpoint, the technology standpoint and operational standpoint and lastly but most importantly from an regulatory standpoint. So, I think what is important to state is that as the revenue is growing the employee cost will also have to kind of being link in some form or the other to ensure that it is able to it is sustained the growth is expected.”
What I understand is that they gave a bonus to reduce attrition and compensate for growth in the business to all employees. There is some regulatory requirement to link employee salary with profit (not sure). They are not guiding for future expenses. Higher employee cost will reduce margin if growth stagnates in coming quarters.
