The company is confident of addressing these observations effectively through a Corrective and Preventive Action (CAPA) plan, expeditiously, it added.
Biocon will be responsible for the development, manufacturing and supply of the products while CMS will be responsible for registration and commercialisation of the products in China.
Index of Industrial Production and Consumer Price Index data will be released on September 12.
Founded in 2016, Biocon Biologics India (BBIL) is reported to be the fastest-growing division within Biocon, with a 97 percent growth in revenue to Rs 1,516 crore in FY19 compared to FY18.
The company will be selling the drug under brand name Ogivri, which will be used for the treatment of HER2 sub-type breast cancer and metastatic stomach cancer.
ICICI Direct is bullish on Biocon has recommended buy rating on the stock with a target price of Rs 330 in its research report dated July 26, 2019.
The biosimilar launched by Amgen and Allergan hit the Biocon scrip, which dropped 8.17 percent and was trading at Rs 241.55 on the BSE at 3 pm.
Trends on SGX Nifty indicate a flat to negative opening for the broader index in India, a fall of 7.5 points or 0.06 percent. Nifty futures were trading around 11,539-level on the Singaporean Exchange.
As per the USFDA, the Form 483 notifies the company's management of objectionable conditions after the conclusion of an inspection.
The European agency inspected Bengaluru unit in March 2019.
At 1114 hrs, Biocon was quoting Rs 606.50, down 2.15 percent on the BSE.
ICICI Direct is bullish on Biocon has recommended buy rating on the stock with a target price of Rs 730 in its research report dated April 26, 201
Total revenue during the quarter grew by 26 percent to Rs 1,557 crore.
Net Sales are expected to increase by 31.6 percent Y-o-Y (down 0.1 percent Q-o-Q) to Rs. 1,538.7 crore, according to Kotak.
'The inspection at the Bengaluru facility took place between February 25-March 5, resulting in a Form 483 with six observations,' it added.
Hamacher comes with more than 20 years of leadership experience in both strategic and operational roles across the value chain in global pharma spanning Asia, Europe and the US, Biocon said in a BSE filing.
Biocon is at the confluence of multiple technical indicators and post a smart rally
ICICI Direct is bullish on Biocon has recommended buy rating on the stock with a target price of Rs 760 in its research report dated January 25, 2019.
Biocon's Q3 net profit more than doubled, rising 136.34 percent YoY to Rs 217.2 crore.
Revenues from the biologics vertical, that comprises biosimilars, rose 136 percent to Rs 449 crore driven by the biosimilar Pegfilgrastim gaining market share in the US.