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Saturday, 30 December 2017

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Zydus receives final approval from the USFDA for Clomipramine Hydrochloride Capsules
Zydus Pharmaceuticals (USA) Inc, a wholly owned subsidiary of Cadila Healthcare Ltd has received the final approval from the USFDA to market Clomipramine Hydrochloride Capsules. The drug is used to treat obsessive compulsive disorder. This is positive news for the company, as it will consolidate Cadila’s position in the US generic market and improve its US Sales.
The company now has more than 175 approvals and has so far filed over 310 ANDAs since the commencement of the filing process in FY 2003-04. The stock is trading at 28x its FY19E P/E. We have negative outlook on the stock due to expensive valuation and increasing competitive intensity in Lialda, post AG launch.

Govt. approves construction of 5.45 lakh houses under Pradhan Mantri Awas Yojana
The Ministry of Housing and Urban Affairs approved the construction of an additional 5,45,090 houses under the Pradhan Mantri Awas Yojana (Urban) scheme. The additional construction is expected to require an investment of Rs31,003cr. Central assistance for the new construction would be Rs8,107cr. This takes the total homes sanctioned under PMAY(U) to 36,00,819.
Andhra Pradesh and Uttar Pradesh have got the nod for constructing 1,42,447 and 1,20,645 affordable houses respectively, while Karnataka and Madhya Pradesh have been sanctioned 1,18,646 and 1,00,341 affordable houses.

Alkem Labs gets USFDA nod for Triamcinolone Acetonide topical cream
Alkem Labs has received USFDA nod for its abbreviated new drug application (ANDA), Triamcinolone Acetonide topical cream. This medication is used to treat a variety of skin conditions (e.g. eczema, dermatitis, allergies, rash).
Alkem Labs' US business contributed 16.5% to its total sales in Q2FY18. The company has mentioned that dermatology therapy is one of its key area of focus. As on 30th September 2017, the company has filed a total of 95 ANDAs (including 1 new drug application (NDA)) with the USFDA and has received 43 approvals (including 5 tentative approvals and 1 NDA).

Lupin receives USFDA nod for Calcipotriene Topical Solution, generic of Dovonex Scalp solution
Lupin, through its filing on BSE, has informed that it has received final approval for its Calcipotriene Topical Solution, 0.005% (Scalp Solution) from the United States Food and Drug Administration (USFDA) to market a generic version of Dovonex Scalp Solution, 0.005% of Leo Pharmaceutical Products Ltd.
Lupin’s Calcipotriene Topical Solution, 0.005% (Scalp Solution) is the AT rated generic equivalent of Leo Pharmaceutical Products Ltd’s Dovonex Scalp Solution, 0.005%. It is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp.
Calcipotriene Topical Solution, 0.005% (Scalp Solution) had annual sales of approximately USD 5.9 million in the US (IMS MAT October 2017).

Bank of Baroda enters into SPA to buy out JV partner’s stake
Bank of Baroda (BoB) has entered into an agreement with UniCredit S.p.A. to acquire their 51% stake in Baroda Pioneer Asset Management Company, as per the BSE filing.
Pursuant to the share purchase agreement (SPA), the Bank will be purchasing from its joint venture partner, UniCredit, their entire equity stake of 51% in the Baroda Pioneer AMC and the Trustee company. Post the acquisition, BoB will become the sole shareholder of the AMC and the Trustee company and sole sponsor of the Baroda Pioneer Mutual Fund. The agreement is subject to approval from regulatory authorities.
The move comes on the back of the acquisition of Pioneer Investments by Amundi earlier this year. Amundi already has a presence in an Indian AMC. The management indicated that they see great opportunity in creating AMC business given the rapid growth in the mutual fund industry. It aims at becoming a meaningful player in the asset and wealth management space.

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