Gland Pharma said that the United States Food and Drug Administration (US FDA) has conducted an un-announced inspection of the company’s Pashamylaram Facility at Hyderabad for good manufacturing practices (GMP).

US FDA issues 3 Form 483 observations to Gland Pharma’s Pashamylaram facility

The inspection at the Hyderabad facility took place between July 25, 2024 and August 02, 2024.

USFDA issues 3 observations to Gland Pharma Hyderabad Unit, stock down 6%

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Gland Pharma’s Dundigal facility receives Form 483 with two procedural observations from U.S. FDA, corrective actions underway.

U.S. FDA issues two observations for Gland Pharma facility

The two observations received were neither repeated nor related to data integrity, the company said.

Gland Pharma’s Hyderabad Facility Gets Two US FDA Observations

The inspection was concluded with TWO (2) 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity.

USFDA conducts surprise inspection of Gland Pharma’s Dundigal facility

Gland Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024%.

Gland Pharma receives USFDA tentative approval for Latanoprostene Bunod Ophthalmic Solution

Gland Pharma receives USFDA tentative approval for Latanoprostene Bunod Ophthalmic Solution, a generic version of Vyzulta with exclusivity potential.

Gland Pharma gets USFDA nod for glaucoma drug

Gland Pharma USFDA approvals: Gland Pharma, a Hyderabad-based generic injectable-focused company, received tentative approval for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent

Gland Pharma, Zydus Lifesciences secure USFDA approvals for key medications

Gland Pharma’s stock is poised to break its ₹2,100 resistance and may rise to ₹2,600. Buy at ₹1,992, accumulate at ₹1,700, and use a stop-loss at ₹1,450, adjusting as the price moves towards ₹2,250 and ₹2,450, with profits to be booked at ₹2,580. Tata Teleservices (Maharashtra) gained 33% last week and has established ₹74 as a solid support. Buy now at ₹102, add more at ₹85, and use a stop-loss at ₹45. Exit one-fourth of your holdings at ₹140, adjust the stop-loss to ₹115, and further adjust to ₹160 on a rise to ₹175, with full exit at ₹200. Timken India, after peaking at ₹4,816 in June, is now at ₹3,937.55. Buy at ₹3,930, add at ₹3,650, with a stop-loss initially at ₹3,200, and aim for ₹5,000.

Technical Analysis: Gland Pharma, Tata Teleservices (Maharashtra) and Timken India

Gland Pharma Ltd is quoting at Rs 1950.1, up 3.45% on the day as on 12:49 IST on the NSE. The stock is up 79.77% in last one year as compared to a 26.03% spurt in NIFTY and a 49.06% spurt in the Nifty Pharma index.

Gland Pharma Ltd spurts 3.45%, gains for third straight session

Hasn't fared well - amongst the low performers

Performance

Seems to be overvalued vs the market average

Valuation

Lagging behind the market in financials growth

Growth

Showing good signs of profitability & efficiency

Profitability

The stock is overpriced but is not in the overbought zone

Current price is more than the intrinsic value

Fundamentals

Good time to consider, stock is not in the overbought zone

Technicals

Entry point

Promoter pledged holding

Unsolicited messages

Default probability

Red flags

Gland Pharma is engaged in manufacturing small volume parenterals (SVPs) and contract development services.

Gland Pharma Ltd