Granules India Ltd

(Rajeev M. Parashar) #551

Granules India receives 11 observations from Portuguese drug regulator

Granules India Ltd has received eleven observations from Infarmed, the Portuguese drug
regulator, for its facility located at Gagillapur, Telangana. These observations were issued by Infarmed after it conducted a renewal inspection on the company’s Gagillapur facility, which manufactures pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).

“The company has initiated necessary and preventive action plan within the stipulated time. It will also be requesting the Infarmed for re-inspection of the Gagillapur facility at the earliest. The company is committed to comply with all the required regulatory requirements and follow the best practices of the industry. The company acknowledges the observations as area of continuous improvements,”

Disclosure: Invested

(Rajesh_R) #552

Seems like minor observations - will wait for official confirmation but 11 observations seems like a lot.

(amil) #553

Is this not the same facility that cleared USFDA inspection (w/o obs.) sometime October?

It seems like an irony that FDA cleared inspection has met with 11 obs fm portugal authorities. And the price today seems to take this harshly (I know the voting vs weighing machine theory but still the news has been viewed serious)

Either Granules materially altered (or became lax post FDA ins.) their functioning at the plant or Portugal has stricter norms? Both seem less likely. Am I missing seeing something here?

Also, if some experienced members may share, is there a case wherein pharma facilities’ areas are demarcated country wise? (seems unlikely to me but just want to understand better)

Disc: Invested


See Rs 28 cr sales hit on Gagillapur unit observations: Granules


The headline is slightly misleading as the worst case scenario is 28cr for a quarter. They have suspended sales In Portugal from Granules. I didn’t understand why there is a confusion regarding eGMP certificate. Overall minor hit to revenue/PAT but slightly higher hit on clean regulatory record.

Disc: Invested

(csteja) #556
  1. Any idea when equity dilution of about 10% due to promoter warrants will be complete and its status ?
  2. Did they stop manufacturing only to Portugal or entire Europe which brings the question does portugal has a different regulator from Europe ?
  3. The Vizag plant which received 7 observations is continuing sales. The mgmt said “We also produce only intermediates in that plant so there is no effect on sales and there is no impact on revenues”. I have a question here. Does impact varies depending upon whether they manufacture API, CRAMPS or formulations in a plant ? Can some pharma expert enlighten on this.

DISC: Sold recently. Currently no holdings.

(csteja) #557

This article says banned from sale in Europe
Read more at:

(rkothuri) #559

That article doesn’t say that it’s resolved.

Here is the summary:

  1. Most of the items are resolved and expect to complete everything and send details by Jan 17.
  2. It’s still unclear what happens to the sales?
    Whether sales in Portugal(1.5 cr) gets affected or whole EU sales (28 cr) gets affected.
  3. Also there is no clear date on when they come for re-inspection.

(csteja) #560

Any idea guys from where (sources) we can check the observations report ?

(Praveen Balla) #561

Looks like promoter stake slightly up with insider buying. Good signs?

Name of Person Category of Person * Securities held pre Transaction Securities Acquired / Disposed Securities held post Transaction Period ## Mode of Acquisition # Trading in Derivatives Reported to Exchange
Type of Securities ** Number Value Transaction Type Type of Contract Buy Value (Units~) Sale Value (Units~)
Ramanavarapu Vidya Promoter 422604 (0.19) Equity Shares 1450 1.52 Lakhs Acquisition 424054 (0.19) 10/01/2017 10/01/2017 Market 18/01/2017
Priyanka Chigurupati Promoter 1947898 (0.88) Equity Shares 2500 2.62 Lakhs Acquisition 1950398 (0.88) 10/01/2017 10/01/2017 Market 12/01/2017
Pragnya Chigurupati Promoter 1959520 (0.89) Equity Shares 4800 5.01 Lakhs Acquisition 1964320 (0.89) 10/01/2017 10/01/2017 Market 11/01/2017

Results on 28th and Concall on 30th

Disc: Invested

(Harpreet Singh) #562

sir this is too insignificant anything to be of any consequence to an investment decision in my opinion !

(Praveen Balla) #563

Ok, thank you for teaching me Sir :slight_smile: Still a student.

(Harpreet Singh) #564

rather such small buyings are often used to mislead …so i would be wary unless its consistent buying or a large significant buying !

(Praveen Balla) #565

What should be made of this? Please note that this is in Q4 and different from the small% in Q1/Jan above.

What constitutes a significant buying? 1% or 5%?

(Harpreet Singh) #566

This is decent commitment …1% should normally be significant !


need to check but I think it is warrant subscription. I have not seen any update of market purchase.

(MHS) #568

Q3 Results are out:

(Furkan Alam) #569

(Furkan Alam) #570

Gagillapur unit observations by Portugal authority - clarified in ConCAll by Granules management that the observations were quite procedural and nothing realted to quality and Granules have taken measures on that already and expect the Portugal authority to re-inspect in next 1-3 days. They expect these to be cleared.

(Amit) #571

Capacity addition (under implementation) is Metformin and Guaifenesin is a high growth CAGR business and no more capacity expanision highlighted for ibuprofen.