Discover and read the best of Twitter Threads about #usfda

Most recents (6)

#glandpharma
Injectable focused B2B company
Mkt includes US,Europe,India,Australia
Niche area - sterile injectables,Oncology,Opthalmic solns
Focus -complex injectables,first to file,NCE-1, 505(b)(2) filings
Chinese promoter Shanghai Fosun Pharma is a global pharma major
#pharma
Fosun acquired controlling stake in gland 74% in 2017 for $1.09 bn
Gland has 267 ANDA filings in the US Mkt, 215 approved
267 filings - 191 sterile injectables, 50 oncology ,26 ophthalmic
Out of 267,101 ANDA are owned by Gland of which 71 approved
Good regulatory compliance
No #USFDA warning letter till date
7 mftng facilities - 4 finished Formulations, 3 API
API facilities 100% captive consumption
63% of Fy20 revenue of 2633 cr were from US mkt
Focus on injs with high entry barrier, limited competition, strict regulatory reqs

#API #cdmo
Read 12 tweets
@GranulesIndia earnings call transcript Q2fy21
No longer a 5 product company
22 launched products
PAT growth up 80% H1fy21 compared to H1fy20,due to fast approval of filed ANDAs,rapid scale up production
Ebidta,PAT > Rev growth- better product mix,sales,op efficiency
#Stocks
32 approved ANDAs(6 yet to launch),13 waiting for approval
Expect 1 MUPS tech based ANDA in Q3 or Q4
Construction MUPS block on track,commercialize Q3fy22
High vol MUPS products & APIs next major driver
Q1fy21 recall of $2 mn tabs Metformin 750mg,this Q 1mn reversed into books
Covid expense 19.3 crs in H1fy21
Rev Q1fy20/21 858/700 cr up23% yoy
Gross margin moved 48.6 to 57.9% YoY thru new launches,increased finished dosages,product rationalization in PFI & Finished dosages
PAT 164 vs 96 crs,up 71% yoy
#Stocks #pharma #Nifty #sensex
Read 10 tweets
The long #thread on How #China became global #antiobiotic supplier and it's effect on US. #penicillin #vitamins #generics #USFDA #chloramphenicol #WhiteHouse (1/22)
During the Civil War, #MaoZedong had seen his troops fell in large numbers by diseases like dysentery, which was fatal when penicillin was unavailable.

history.state.gov/milestones/194…

2/22.
North #China became the centerpiece of Chinese government’s larger, state-directed plan for self reliance on Chinese #antibiotics.

3/22.
Read 25 tweets
I have been receiving requests to write about When to sell a stock/ investment ? #Whentosell

I’m writing this thread based on when I sell and logic behind the selling an investment

1. I sell when my investment thesis is wrong or the investment is playing out for wrong reasons
I invested in a few pharma companies with a hypothesis that #USFDA issues,pricing issues will be sorted and growth return to normal, but currently pharma has given me > 100 % returns for wrong reasons which I did not hypothesise #Covid19
2. I sell when my research or my analysis is wrong

In 2016 I invested in #Tarajewels based on #Graham net net, I was on a 30% profit, when i reanalyzed I found I missed to take into account #contingentliabilities and sold the position.
Read 13 tweets
📕 A Quick Story:
Ipca Labs and the rise of its stock price by +40% in the last 2 months.

🔸 For the last 5 years, US FDA had imposed a complete ban on import of any drugs from #IpcaLabs

🔸 The reason cited by #USFDA was manufacturing lapses at Ipca's factories

(1/5)
🔸 As the coronavirus pandemic broke across the world, a drug called #Hydrochloroquine (HCQ) was found to be effective against the virus.

🔸 India's pharma companies have always been producers of cheap generic drugs.

(2/5)
🔸 As the HCQ news was announced, India imposed a complete ban on export of HCQ drugs.

🔸 As many as 30 countries, including the US approached India to get a supply of #HCQ tablets.

🔸 US went as far as threatening with a "retaliation" if India does not supply them HCQ.

(3/5)
Read 5 tweets
- Pharma MNCs riding on innovation & operating in niche therapies (less competition), focus on few brand & enjoy premium pricing, 100% focus on India market.
- Indian cos; struggle with regulatory hurdles (US FDA), 70% revenue from overseas biz, currency & geopolitical risks. Image
Indian pharma companies are facing a lot of compliance issues. If current situation continues, they might not get approval of pending products which ultimately impact on topline of these companies
#Lupin
#AurobindoPharma
#Cipla

@caniravkaria @_N_U_P_K_Y
Pfizer Q2 sales 567crs vs 519 crs, net profits up 60% at 154 crs vs 96

As mentioned, Pharma MNCs are exceedingly doing well compared to Indian pharma players!!

#Pfizer
#Abbott
#Merck
#Sanofi
#Glaxosmith
Read 10 tweets

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