Shilpa Medicare -Racing away on the Oncology API highway!

(MONK88888) #548

Just some musings to get to EPS of 18.5 (as per certain research reports)-at current rate of EPS , its is a tall target
The CRAMS which was in standalone had a turnover of 220 cr of which 100 cr would be transferred to Raichem by end FY18 As the capacity stabilization is happening the loss on consolidated on account of CRAMs is around 4.89 cr as on H1 2018. This may end flat for FY2018
Plan A: With Jadcherla , they ramp up azac. & capac. but one has to note that the prices of these drugs have been sliding since 2012 & are at all time lows. So even if they do well on the above ,it may not move the needle much (again low probability to move the EPS)
Plan B: They move 100 cr CRAMS to Raichem (as per their plan) & get the batches stabilised & meanwhile get Japan approval (tranexamic acid production from new plant along with ursodeoxy.) , which will utilise the Raichem capacity & could add around 15 cr to NP as opposed to flat to slight negative (as anticipated by FY2018 end-based on 50 pct profit sharing)
Plan C: With Jadcherla approval , more ANDA`s get approved leading to increase in sales in US (again a decent probability event). Also increased sales for Onco in Europe is another high probability event
Plan D: Growth in non Onco products like oral strips / opthalmic -driven by capacity available post shift of CRAMS to Raichem (like Acebrophylline / Ambroxol etc.-not sure of how probable this is )

Also Dec quarter based on seasonality is a lot lower than Sep unless either of above plan materializes

Assuming that I have funds I will add to position around 575 or on a break 700. At current , just hold on to my existing

(Sarabjeet Singh) #549

Shilpa got some observations from USFDA , declared after market hours

a) Total 10 observations were cited during the close up meeting.
b) 7 observations are improvement in procedures and practices.
c) 3 observations are related to setting of analytical specifications, test procedures
and method validation.

(Divyansh Gupta) #550

Came across this video on CAR-T which can cure cancer naturally… this info was mentioned earlier in the forum as well

(Sandeep Patel) #551

Update by Motilal Oswal…

The Form 483 resolution may take 3-6 months.

  • The USFDA, at its inspection held from 20-30th November 2017, issued 10 observations for the company‚Äôs Jadcherla facility. This is the fourth USFDA inspection at this facility over the past three years.
  • One observation highlights the need for (i) thorough investigation of complaints and out of specification (OOS) laboratory results and (ii) strengthening of procedures. In our view, resolution of this issue would not take more than three months. The USDFA appears to have made its norms stricter for OOS (it has been part of 483s for many companies of late), and thus, SPLA needs to be more vigilant about OOS-related compliance.
  • Another observation highlights the gaps in performing activities during filling which might lead to microbial contamination of drug, which again necessitates strengthening of procedures. As Jadcherla is a sterile facility, resolution of this issue is critical, which could take at least three months, in our view.
  • One of the observations highlights that the written stability program does not include reliable, meaningful and specific test methods. This indicates the need for review of the acceptance criteria for stability indicating parameters. In some cases, the company may have to re-look at the methods from the reliability perspective. Resolution of this issue may take at least three months.
  • Furthermore, the USFDA, in one of its observations, highlighted the need for a change in software or existing software to provide permit to single processing method. Resolution of this issue may take 1-3 months.
  • Another observation highlighted the need for review of acceptance criteria for sampling/testing, as they are not adequate to assure that drug products meet appropriate specification. Resolution of this issue may take three months.
  • Another observation indicates that company may have to provide scientific and statistical rational for sample sizes, or change the method as mentioned in pharmacopeia and reconfirm their test results. This may take 3-6 months.

Either product approvals or the receipt of EIR for this facility will be an indication of successful USFDA compliance.


(Bhaskar Jain) #552

Saw this article today, thought of sharing with you -

(Shivashankar) #553

Recent FDA inspection report findings has 10 observations … not sure of the implications… can anyone let us know how big is this finding?

(Rajarshi) #554