 Hey, I want to invite you to join Stocktwits. It’s the largest global community of active traders. You’ll get access to the real-time market insights, news, discussion and much more! You can sign up using my unique link below 
 


 has invited you to join Stocktwits

Shilpa Medicare announced that the 36th Annual General Meeting (AGM) of the company will be held on 29 September 2023.

Shilpa Medicare AGM scheduled

In an exchange filing, the pharma company said that Shilpa Pharma Lifesciences active pharmaceutical ingredient (API) manufacturing facility, Unit II, situated at Raichur in Karnataka state has undergone a GMP inspection by Pharmaceuticals and Medical Devices Agency (PMDA), Japan starting 29 August 2023.The inspection has concluded successfully on 1 September 2023 without any criticalmajor observation, it added.The facility is involved in manufacturing various oncology and non&#8208;oncology APIs.  The company stated that it remains committed to maintain the GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities. Meanwhile, Shilpa Medicare informed that it has received marketing authorization from Medicines and Healthcare Products Regulatory Agency (MHRA), UK, for Betahistine Dihydrochloride Orodispersible Films, 24 mg.Betahistine is indicated for the treatment of vertigo, tinnitus, hearing loss and nausea associated with Menieres syndrome and is available as tablets and oral liquid dosage forms in various strengths across UK, Europe. The Orally dispersibledissolvable film formulation offers benefits with respect to patient compliance and ease of administration.The drug maker said that it is the first company to receive approval for the 24 mg strength as a Film formulation in UK. The companys approval is a hybrid product application, which is bioequivalent to the reference product, it added.This approval has come from the companys finished dosage form manufacturing facility, Shilpa Medicare, Unit VI, located at Dabaspet, Bengaluru, Karnataka. The facility is approved by MHRA UK and this is the first approval for a prescription Oral Film product in regulated market from this facility. The facility is involved in manufacturing, packaging, labelling and testing of finished dosage forms (oral dispersibledissolving Films and Transdermal Patches).  Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated marketsThe companys consolidated net profit jumped 38.8% to Rs 1.18 crore as compared with Rs 0.85 crore in Q1 FY23. Net sales fell 0.4% year on year to Rs 260.17 crore in Q1 FY24.Shares of Shilpa Medicare gained 0.98% to Rs 374.60 on the BSE.

Shilpa Medicare Karnataka unit clears PMDA inspection 

The company received marketing authorization from Medicines and Healthcare Products Regulatory Agency, UK, for Betahistine Dihydrochloride Orodispersible Films, 24 mg

Shilpa Medicare up on UK nod to market vertigo drug, clearing Japanese inspection

 Shilpa Medicare announced that the Companyfs finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana state has undergone a GMP inspection by ANVISA, Brazil starting 21 August 2023. The inspection has concluded successfully on 24 August 2023 without any observations.  The facility is involved in manufacturing, packaging, labelling and testing of finished dosage forms (sterile injections and non]sterile oral solids) for the treatment of various forms of cancer and adjuvant therapy.  This inspection is the third major regulatory inspection (after Russia and Canada), cleared by this Site in the past two years. This inspection and subsequent approval will allow the company for the commercial distribution of products in Brazil market and enable approval of new applications for Brazil market.  

Shilpa Medicare's Unit IV clears inspection by Brazilian Health Authority - ANVISA 

The facility is involved in manufacturing, packaging, labelling and testing of finished dosage forms (sterile injections and non&#8208;sterile oral solids) for the treatment of various forms of cancer and adjuvant therapy.    The inspection was carried from 21 August 2023 to 24 August 2023, the inspection has concluded without any observations.This inspection is the third major regulatory inspection (after Russia and Canada), cleared by this Site in the past two years. This inspection and subsequent approval will allow the company for the commercial distribution of products in Brazil market and enable approval of new applications for Brazil market. The firm said that it remains committed to maintain the GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities.   Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated marketsThe companys consolidated net profit jumped 38.8% to Rs 1.18 crore as compared with Rs 0.85 crore in Q1 FY23. Net sales fell 0.4% year on year to Rs 260.17 crore in Q1 FY24. The scrip declined 0.56% to Rs 363.55 on the BSE.

Shilpa Medicare's Telangana facility clears ANVISA, Brazil inspection 

Shilpa Consolidated June 2023 Net Sales at Rs 260.17 crore, down 0.38% Y-o-Y

Shilpa Medicare will hold a meeting of the Board of Directors of the Company on 10 August 2023.

Shilpa Medicare to declare Quarterly Result

Shilpa Standalone March 2023 Net Sales at Rs 66.50 crore, down 8.75% Y-o-Y

This was the second US FDA inspection of the facility, which tests drugs, raw material and packing materials, within a year

Shilpa Medicare continues to fall despite US FDA relief for Hyderabad unit

In an exchange filing made after trading hours on Monday, the company said that it has received U.S Food and Drug Administration (US FDA) final approval for its abbreviated new drug application (ANDA), Apremilast Tablets, 10 mg, 20 mg, and 30 mg for the treatment of adult patients with active psoriatic arthritis. The product is executed from a contract manufacturing site.Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.Apremilast is a medication for the treatment of certain types of psoriasis and psoriatic arthritis. It may also be useful for other immune system-related inflammatory diseases.According to IQVIA MAT Q4 2022 data, the US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately $3.55 billion.Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.The company reported a consolidated net loss of 6.62 crore in Q3 FY23 as against a net profit of Rs 9.57 crore posted in Q3 FY22. Net sales declined 3.6% year on year to Rs 262.50 crore during the quarter.

Shilpa Medicare spurts after US FDA grants approval for psoriatic arthritis drug

Shilpa Medicare Ltd. engages in the manufacturing of pharmaceutical products and wind power generation. The company was founded on November 20, 1987 and is headquartered in Raichur, India.

Watchers	26
52-Wk Low	222.60
52-Wk High	387.50

Market Cap	31.13B
Volume (M)	99,148.00
52-Wk High	387.50
52-Wk Low	222.60

SHILPAMED.NSE Shilpa Medicare Ltd.

About

Feed

News

Sentiment

Fundamentals